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Nicotine
Nicotine Polacrilex · Gum, Chewing
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Cholinergic Nicotinic Agonist [EPC] | EPC | All 61 members |
| Nicotine [CS] | CS | All 61 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 206393-001 | NICOTINE POLACRILEX | GUM, CHEWING | NICOTINE POLACRILEX | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 14 | Labeling | Approved | September 21, 2023 | Standard |
| Supplement | 13 | Manufacturing (CMC) | Approved | January 5, 2022 | Unknown |
| Original application | 1 | Approved | December 15, 2016 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260824). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Purpose
openFDA Drug LabelingPurpose Stop smoking aid
Dosage and Administration
openFDA Drug LabelingDirections - 2 mg • if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User's Guide for complete directions and other important information • begin using the gum on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours • nicotine gum is a medicine and must be used a certain way to get the best results • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again until the tingle returns. • repeat this process until most of the tingle is gone (about 30 minutes) • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. • do not use more than 24 pieces a day • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.
Directions - 4 mg • if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User's Guide for complete directions and other important information • begin using the gum on your quit day • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours • nicotine gum is a medicine and must be used a certain way to get the best results • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again until the tingle returns. • repeat this process until most of the tingle is gone (about 30 minutes) • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. • do not use more than 24 pieces a day • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to our health care provider.
Warnings
openFDA Drug LabelingWarnings If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Ask a doctor before use if you have • a sodium-restricted diet • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. • high blood pressure not controlled with medication. Nicotine can increase blood pressure. • stomach ulcer or diabetes • history of seizures Ask a doctor or pharmacist before use if you are • using a non-nicotine stop smoking drug • taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if • mouth, teeth or jaw problems occur • irregular heartbeat or palpitations occur • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat • oral blistering occurs • you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children and pets. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have • a sodium-restricted diet • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. • high blood pressure not controlled with medication. Nicotine can increase blood pressure. • stomach ulcer or diabetes • history of seizures
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • mouth, teeth or jaw problems occur • irregular heartbeat or palpitations occur • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat • oral blistering occurs • you have symptoms of an allergic reaction (such as difficulty breathing or rash)
Active Ingredient
openFDA Drug LabelingActive ingredient (in each chewing piece) - 2 mg Nicotine Polacrilex (equal to 2 mg nicotine)
Active ingredient (in each chewing piece) - 4 mg Nicotine Polacrilex (equal to 4 mg nicotine)
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Product: 50090-6674 NDC: 50090-6674-0 110 GUM, CHEWING in a CARTON / 1 in a BLISTER PACK
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: NICOTINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-6674-0 | 50090-6674 | A-S Medication Solutions | 1 CARTON in 1 BLISTER PACK (50090-6674-0) / 110 GUM, CHEWING in 1 CARTON | December 28, 2023 |
| 72288-518-06 | 72288-518 | Amazon.com Services LLC | 160 BLISTER PACK in 1 CARTON (72288-518-06) / 1 GUM, CHEWING in 1 BLISTER PACK | August 12, 2026 |
| 72288-518-60 | 72288-518 | Amazon.com Services LLC | 20 BLISTER PACK in 1 CARTON (72288-518-60) / 1 GUM, CHEWING in 1 BLISTER PACK | August 20, 2026 |
| 72288-540-01 | 72288-540 | Amazon.com Services LLC | 310 BLISTER PACK in 1 CARTON (72288-540-01) / 1 GUM, CHEWING in 1 BLISTER PACK | August 27, 2026 |
| 72288-540-29 | 72288-540 | Amazon.com Services LLC | 220 BLISTER PACK in 1 CARTON (72288-540-29) / 1 GUM, CHEWING in 1 BLISTER PACK | May 18, 2026 |
| 46122-719-60 | 46122-719 | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 20 BLISTER PACK in 1 CARTON (46122-719-60) / 1 GUM, CHEWING in 1 BLISTER PACK | September 30, 2022 |
| 46122-724-25 | 46122-724 | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 110 BLISTER PACK in 1 CARTON (46122-724-25) / 1 GUM, CHEWING in 1 BLISTER PACK | February 13, 2023 |
| 46122-733-60 | 46122-733 | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 20 BLISTER PACK in 1 CARTON (46122-733-60) / 1 GUM, CHEWING in 1 BLISTER PACK | September 30, 2022 |
| 51316-151-10 | 51316-151 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 100 BLISTER PACK in 1 CARTON (51316-151-10) / 1 GUM, CHEWING in 1 BLISTER PACK | May 26, 2026 |
| 51316-151-16 | 51316-151 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 160 BLISTER PACK in 1 CARTON (51316-151-16) / 1 GUM, CHEWING in 1 BLISTER PACK | May 26, 2026 |
| 51316-151-20 | 51316-151 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 20 BLISTER PACK in 1 CARTON (51316-151-20) / 1 GUM, CHEWING in 1 BLISTER PACK | June 16, 2026 |
| 51316-309-10 | 51316-309 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 100 BLISTER PACK in 1 CARTON (51316-309-10) / 1 GUM, CHEWING in 1 BLISTER PACK | May 27, 2026 |
| 51316-309-16 | 51316-309 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 160 BLISTER PACK in 1 CARTON (51316-309-16) / 1 GUM, CHEWING in 1 BLISTER PACK | May 28, 2026 |
| 51316-309-20 | 51316-309 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 20 BLISTER PACK in 1 CARTON (51316-309-20) / 1 GUM, CHEWING in 1 BLISTER PACK | June 17, 2026 |
| 55154-6818-0 | 55154-6818 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-6818-0) / 1 GUM, CHEWING in 1 BLISTER PACK | August 24, 2026 |
| 55910-918-20 | 55910-918 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 20 BLISTER PACK in 1 CARTON (55910-918-20) / 1 GUM, CHEWING in 1 BLISTER PACK | May 1, 2023 |
| 55910-918-40 | 55910-918 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 40 BLISTER PACK in 1 CARTON (55910-918-40) / 1 GUM, CHEWING in 1 BLISTER PACK | May 1, 2023 |
| 37808-611-96 | 37808-611 | H E B | 170 BLISTER PACK in 1 CARTON (37808-611-96) / 1 GUM, CHEWING in 1 BLISTER PACK | July 31, 2023 |
| 37808-658-06 | 37808-658 | H E B | 160 BLISTER PACK in 1 CARTON (37808-658-06) / 1 GUM, CHEWING in 1 BLISTER PACK | May 3, 2019 |
| 37808-682-06 | 37808-682 | H E B | 160 BLISTER PACK in 1 CARTON (37808-682-06) / 1 GUM, CHEWING in 1 BLISTER PACK | May 6, 2019 |
| 37808-683-06 | 37808-683 | H E B | 160 BLISTER PACK in 1 CARTON (37808-683-06) / 1 GUM, CHEWING in 1 BLISTER PACK | July 1, 2019 |
| 37808-711-06 | 37808-711 | H E B | 160 BLISTER PACK in 1 CARTON (37808-711-06) / 1 GUM, CHEWING in 1 BLISTER PACK | May 2, 2019 |
| 37808-739-06 | 37808-739 | H E B | 160 BLISTER PACK in 1 CARTON (37808-739-06) / 1 GUM, CHEWING in 1 BLISTER PACK | May 1, 2019 |
| 37808-781-60 | 37808-781 | H E B | 20 BLISTER PACK in 1 CARTON (37808-781-60) / 1 GUM, CHEWING in 1 BLISTER PACK | April 12, 2019 |
| 37808-781-96 | 37808-781 | H E B | 170 BLISTER PACK in 1 CARTON (37808-781-96) / 1 GUM, CHEWING in 1 BLISTER PACK | April 12, 2019 |
| 37808-820-16 | 37808-820 | H E B | 160 BLISTER PACK in 1 CARTON (37808-820-16) / 1 GUM, CHEWING in 1 BLISTER PACK | October 28, 2022 |
| 37808-821-16 | 37808-821 | H E B | 160 BLISTER PACK in 1 CARTON (37808-821-16) / 1 GUM, CHEWING in 1 BLISTER PACK | October 28, 2022 |
| 37808-849-60 | 37808-849 | H E B | 20 BLISTER PACK in 1 CARTON (37808-849-60) / 1 GUM, CHEWING in 1 BLISTER PACK | April 16, 2019 |
| 37808-849-96 | 37808-849 | H E B | 170 BLISTER PACK in 1 CARTON (37808-849-96) / 1 GUM, CHEWING in 1 BLISTER PACK | April 16, 2019 |
| 37808-909-06 | 37808-909 | H E B | 160 BLISTER PACK in 1 CARTON (37808-909-06) / 1 GUM, CHEWING in 1 BLISTER PACK | June 26, 2019 |
| 42507-309-78 | 42507-309 | HyVee Inc | 100 BLISTER PACK in 1 CARTON (42507-309-78) / 1 GUM, CHEWING in 1 BLISTER PACK | February 25, 2026 |
| 42507-343-78 | 42507-343 | HyVee Inc | 100 BLISTER PACK in 1 CARTON (42507-343-78) / 1 GUM, CHEWING in 1 BLISTER PACK | February 25, 2026 |
| 30142-208-06 | 30142-208 | Kroger Company | 160 BLISTER PACK in 1 CARTON (30142-208-06) / 1 GUM, CHEWING in 1 BLISTER PACK | April 25, 2017 |
| 30142-208-60 | 30142-208 | Kroger Company | 20 BLISTER PACK in 1 CARTON (30142-208-60) / 1 GUM, CHEWING in 1 BLISTER PACK | April 25, 2017 |
| 30142-309-06 | 30142-309 | Kroger Company | 160 BLISTER PACK in 1 CARTON (30142-309-06) / 1 GUM, CHEWING in 1 BLISTER PACK | April 25, 2017 |
| 30142-309-60 | 30142-309 | Kroger Company | 20 BLISTER PACK in 1 CARTON (30142-309-60) / 1 GUM, CHEWING in 1 BLISTER PACK | April 25, 2017 |
| 30142-749-06 | 30142-749 | Kroger Company | 160 BLISTER PACK in 1 CARTON (30142-749-06) / 1 GUM, CHEWING in 1 BLISTER PACK | March 12, 2019 |
| 30142-749-60 | 30142-749 | Kroger Company | 20 BLISTER PACK in 1 CARTON (30142-749-60) / 1 GUM, CHEWING in 1 BLISTER PACK | March 12, 2019 |
| 30142-749-76 | 30142-749 | Kroger Company | 120 BLISTER PACK in 1 CARTON (30142-749-76) / 1 GUM, CHEWING in 1 BLISTER PACK | April 12, 2019 |
| 30142-749-78 | 30142-749 | Kroger Company | 100 BLISTER PACK in 1 CARTON (30142-749-78) / 1 GUM, CHEWING in 1 BLISTER PACK | March 12, 2019 |
| 30142-848-06 | 30142-848 | Kroger Company | 160 BLISTER PACK in 1 CARTON (30142-848-06) / 1 GUM, CHEWING in 1 BLISTER PACK | June 11, 2019 |
| 30142-848-60 | 30142-848 | Kroger Company | 20 BLISTER PACK in 1 CARTON (30142-848-60) / 1 GUM, CHEWING in 1 BLISTER PACK | June 11, 2019 |
| 30142-848-78 | 30142-848 | Kroger Company | 100 BLISTER PACK in 1 CARTON (30142-848-78) / 1 GUM, CHEWING in 1 BLISTER PACK | June 5, 2019 |
| 72224-930-10 | 72224-930 | Lucy Goods, Inc. | 100 BLISTER PACK in 1 CARTON (72224-930-10) / 1 GUM, CHEWING in 1 BLISTER PACK | April 25, 2025 |
| 72224-931-10 | 72224-931 | Lucy Goods, Inc. | 100 BLISTER PACK in 1 CARTON (72224-931-10) / 1 GUM, CHEWING in 1 BLISTER PACK | April 25, 2025 |
| 63739-369-10 | 63739-369 | McKesson Corporation dba SKY Packaging | 100 BLISTER PACK in 1 CARTON (63739-369-10) / 1 GUM, CHEWING in 1 BLISTER PACK | April 27, 2020 |
| 63739-371-63 | 63739-371 | McKesson Corporation dba SKY Packaging | 110 BLISTER PACK in 1 CARTON (63739-371-63) / 1 GUM, CHEWING in 1 BLISTER PACK | April 27, 2020 |
| 41250-029-29 | 41250-029 | Meijer Distribution Inc | 220 BLISTER PACK in 1 CARTON (41250-029-29) / 1 GUM, CHEWING in 1 BLISTER PACK | April 24, 2019 |
| 41250-029-96 | 41250-029 | Meijer Distribution Inc | 170 BLISTER PACK in 1 CARTON (41250-029-96) / 1 GUM, CHEWING in 1 BLISTER PACK | February 6, 2005 |
| 41250-170-29 | 41250-170 | Meijer Distribution Inc | 220 BLISTER PACK in 1 CARTON (41250-170-29) / 1 GUM, CHEWING in 1 BLISTER PACK | April 24, 2019 |
| 41250-170-96 | 41250-170 | Meijer Distribution Inc | 170 BLISTER PACK in 1 CARTON (41250-170-96) / 1 GUM, CHEWING in 1 BLISTER PACK | February 1, 2005 |
| 41250-209-06 | 41250-209 | Meijer Distribution Inc | 160 BLISTER PACK in 1 CARTON (41250-209-06) / 1 GUM, CHEWING in 1 BLISTER PACK | February 8, 2017 |
| 41250-209-78 | 41250-209 | Meijer Distribution Inc | 100 BLISTER PACK in 1 CARTON (41250-209-78) / 1 GUM, CHEWING in 1 BLISTER PACK | February 8, 2017 |
| 41250-456-06 | 41250-456 | Meijer Distribution Inc | 160 BLISTER PACK in 1 CARTON (41250-456-06) / 1 GUM, CHEWING in 1 BLISTER PACK | May 4, 2007 |
| 41250-456-60 | 41250-456 | Meijer Distribution Inc | 20 BLISTER PACK in 1 CARTON (41250-456-60) / 1 GUM, CHEWING in 1 BLISTER PACK | June 20, 2014 |
| 41250-456-70 | 41250-456 | Meijer Distribution Inc | 240 BLISTER PACK in 1 CARTON (41250-456-70) / 1 GUM, CHEWING in 1 BLISTER PACK | June 3, 2011 |
| 41250-456-76 | 41250-456 | Meijer Distribution Inc | 120 BLISTER PACK in 1 CARTON (41250-456-76) / 1 GUM, CHEWING in 1 BLISTER PACK | November 7, 2007 |
| 41250-456-78 | 41250-456 | Meijer Distribution Inc | 100 BLISTER PACK in 1 CARTON (41250-456-78) / 1 GUM, CHEWING in 1 BLISTER PACK | October 31, 2006 |
| 41250-510-06 | 41250-510 | Meijer Distribution Inc | 160 BLISTER PACK in 1 CARTON (41250-510-06) / 1 GUM, CHEWING in 1 BLISTER PACK | February 8, 2017 |
| 41250-510-78 | 41250-510 | Meijer Distribution Inc | 100 BLISTER PACK in 1 CARTON (41250-510-78) / 1 GUM, CHEWING in 1 BLISTER PACK | February 8, 2017 |
| 41250-529-06 | 41250-529 | Meijer Distribution Inc | 160 BLISTER PACK in 1 CARTON (41250-529-06) / 1 GUM, CHEWING in 1 BLISTER PACK | June 30, 2020 |
| 41250-529-76 | 41250-529 | Meijer Distribution Inc | 120 BLISTER PACK in 1 CARTON (41250-529-76) / 1 GUM, CHEWING in 1 BLISTER PACK | November 5, 2021 |
| 41250-529-78 | 41250-529 | Meijer Distribution Inc | 100 BLISTER PACK in 1 CARTON (41250-529-78) / 1 GUM, CHEWING in 1 BLISTER PACK | July 1, 2020 |
| 41250-532-06 | 41250-532 | Meijer Distribution Inc | 160 BLISTER PACK in 1 CARTON (41250-532-06) / 1 GUM, CHEWING in 1 BLISTER PACK | May 3, 2007 |
| 41250-532-60 | 41250-532 | Meijer Distribution Inc | 20 BLISTER PACK in 1 CARTON (41250-532-60) / 1 GUM, CHEWING in 1 BLISTER PACK | June 20, 2014 |
| 41250-532-70 | 41250-532 | Meijer Distribution Inc | 240 BLISTER PACK in 1 CARTON (41250-532-70) / 1 GUM, CHEWING in 1 BLISTER PACK | June 3, 2011 |
| 41250-532-78 | 41250-532 | Meijer Distribution Inc | 100 BLISTER PACK in 1 CARTON (41250-532-78) / 1 GUM, CHEWING in 1 BLISTER PACK | October 31, 2006 |
| 41250-689-06 | 41250-689 | Meijer Distribution Inc | 160 BLISTER PACK in 1 CARTON (41250-689-06) / 1 GUM, CHEWING in 1 BLISTER PACK | January 3, 2020 |
| 41250-689-60 | 41250-689 | Meijer Distribution Inc | 20 BLISTER PACK in 1 CARTON (41250-689-60) / 1 GUM, CHEWING in 1 BLISTER PACK | December 18, 2019 |
| 41250-689-78 | 41250-689 | Meijer Distribution Inc | 100 BLISTER PACK in 1 CARTON (41250-689-78) / 1 GUM, CHEWING in 1 BLISTER PACK | December 21, 2019 |
| 41250-854-76 | 41250-854 | Meijer Distribution Inc | 120 BLISTER PACK in 1 CARTON (41250-854-76) / 1 GUM, CHEWING in 1 BLISTER PACK | August 21, 2009 |
| 79481-0100-0 | 79481-0100 | Meijer, Inc. | 220 BLISTER PACK in 1 CARTON (79481-0100-0) / 1 GUM, CHEWING in 1 BLISTER PACK | June 15, 2023 |
| 79481-0100-1 | 79481-0100 | Meijer, Inc. | 170 BLISTER PACK in 1 CARTON (79481-0100-1) / 1 GUM, CHEWING in 1 BLISTER PACK | April 14, 2026 |
| 79481-0103-0 | 79481-0103 | Meijer, Inc. | 100 BLISTER PACK in 1 CARTON (79481-0103-0) / 1 GUM, CHEWING in 1 BLISTER PACK | June 23, 2023 |
| 79481-0103-2 | 79481-0103 | Meijer, Inc. | 160 BLISTER PACK in 1 CARTON (79481-0103-2) / 1 GUM, CHEWING in 1 BLISTER PACK | March 31, 2026 |
| 79481-0601-0 | 79481-0601 | Meijer, Inc. | 220 BLISTER PACK in 1 CARTON (79481-0601-0) / 1 GUM, CHEWING in 1 BLISTER PACK | August 3, 2023 |
| 79481-0601-1 | 79481-0601 | Meijer, Inc. | 170 BLISTER PACK in 1 CARTON (79481-0601-1) / 1 GUM, CHEWING in 1 BLISTER PACK | April 7, 2026 |
| 79481-0755-0 | 79481-0755 | Meijer, Inc. | 100 BLISTER PACK in 1 CARTON (79481-0755-0) / 1 GUM, CHEWING in 1 BLISTER PACK | June 29, 2023 |
| 79481-0755-1 | 79481-0755 | Meijer, Inc. | 120 BLISTER PACK in 1 CARTON (79481-0755-1) / 1 GUM, CHEWING in 1 BLISTER PACK | February 12, 2024 |
| 79481-0755-2 | 79481-0755 | Meijer, Inc. | 160 BLISTER PACK in 1 CARTON (79481-0755-2) / 1 GUM, CHEWING in 1 BLISTER PACK | April 7, 2026 |
| 59726-592-16 | 59726-592 | P & L Development, LLC | 160 BLISTER PACK in 1 CARTON (59726-592-16) / 1 GUM, CHEWING in 1 BLISTER PACK | March 1, 2024 |
| 59726-913-16 | 59726-913 | P & L Development, LLC | 160 BLISTER PACK in 1 CARTON (59726-913-16) / 1 GUM, CHEWING in 1 BLISTER PACK | March 1, 2024 |
| 59726-929-17 | 59726-929 | P & L Development, LLC | 170 BLISTER PACK in 1 CARTON (59726-929-17) / 1 GUM, CHEWING in 1 BLISTER PACK | March 1, 2024 |
| 59726-935-17 | 59726-935 | P & L Development, LLC | 170 BLISTER PACK in 1 CARTON (59726-935-17) / 1 GUM, CHEWING in 1 BLISTER PACK | March 1, 2024 |
| 45802-651-25 | 45802-651 | Padagis Israel Pharmaceuticals Ltd | 110 BLISTER PACK in 1 CARTON (45802-651-25) / 1 GUM, CHEWING in 1 BLISTER PACK | August 14, 2023 |
| 45802-827-25 | 45802-827 | Padagis Israel Pharmaceuticals Ltd | 110 BLISTER PACK in 1 CARTON (45802-827-25) / 1 GUM, CHEWING in 1 BLISTER PACK | May 22, 2023 |
| 56062-019-60 | 56062-019 | Publix Super Markets Inc | 20 BLISTER PACK in 1 CARTON (56062-019-60) / 1 GUM, CHEWING in 1 BLISTER PACK | June 11, 2026 |
| 56062-019-78 | 56062-019 | Publix Super Markets Inc | 100 BLISTER PACK in 1 CARTON (56062-019-78) / 1 GUM, CHEWING in 1 BLISTER PACK | June 11, 2026 |
| 56062-298-71 | 56062-298 | Publix Super Markets Inc | 110 BLISTER PACK in 1 CARTON (56062-298-71) / 1 GUM, CHEWING in 1 BLISTER PACK | June 11, 2026 |
| 56062-646-60 | 56062-646 | Publix Super Markets Inc | 20 BLISTER PACK in 1 CARTON (56062-646-60) / 1 GUM, CHEWING in 1 BLISTER PACK | June 11, 2026 |
| 56062-646-78 | 56062-646 | Publix Super Markets Inc | 100 BLISTER PACK in 1 CARTON (56062-646-78) / 1 GUM, CHEWING in 1 BLISTER PACK | June 11, 2026 |
| 56062-812-71 | 56062-812 | Publix Super Markets Inc | 110 BLISTER PACK in 1 CARTON (56062-812-71) / 1 GUM, CHEWING in 1 BLISTER PACK | June 11, 2026 |
| 11822-0029-1 | 11822-0029 | Rite Aid Corporation | 110 BLISTER PACK in 1 CARTON (11822-0029-1) / 1 GUM, CHEWING in 1 BLISTER PACK | July 30, 2016 |
| 11822-0029-2 | 11822-0029 | Rite Aid Corporation | 170 BLISTER PACK in 1 CARTON (11822-0029-2) / 1 GUM, CHEWING in 1 BLISTER PACK | July 30, 2016 |
| 11822-0170-1 | 11822-0170 | Rite Aid Corporation | 110 BLISTER PACK in 1 CARTON (11822-0170-1) / 1 GUM, CHEWING in 1 BLISTER PACK | July 20, 2016 |
| 11822-0170-2 | 11822-0170 | Rite Aid Corporation | 170 BLISTER PACK in 1 CARTON (11822-0170-2) / 1 GUM, CHEWING in 1 BLISTER PACK | July 20, 2016 |
| 11822-0269-2 | 11822-0269 | Rite Aid Corporation | 160 BLISTER PACK in 1 CARTON (11822-0269-2) / 1 GUM, CHEWING in 1 BLISTER PACK | September 28, 2023 |
| 11822-0309-1 | 11822-0309 | Rite Aid Corporation | 20 BLISTER PACK in 1 CARTON (11822-0309-1) / 1 GUM, CHEWING in 1 BLISTER PACK | January 24, 2017 |
| 11822-0309-2 | 11822-0309 | Rite Aid Corporation | 100 BLISTER PACK in 1 CARTON (11822-0309-2) / 1 GUM, CHEWING in 1 BLISTER PACK | January 24, 2017 |
| 11822-0456-1 | 11822-0456 | Rite Aid Corporation | 100 BLISTER PACK in 1 CARTON (11822-0456-1) / 1 GUM, CHEWING in 1 BLISTER PACK | October 26, 2006 |
| 11822-0699-1 | 11822-0699 | Rite Aid Corporation | 100 BLISTER PACK in 1 CARTON (11822-0699-1) / 1 GUM, CHEWING in 1 BLISTER PACK | July 28, 2016 |
| 11822-0971-1 | 11822-0971 | Rite Aid Corporation | 20 BLISTER PACK in 1 CARTON (11822-0971-1) / 1 GUM, CHEWING in 1 BLISTER PACK | December 11, 2020 |
| 11822-0971-2 | 11822-0971 | Rite Aid Corporation | 160 BLISTER PACK in 1 CARTON (11822-0971-2) / 1 GUM, CHEWING in 1 BLISTER PACK | March 27, 2023 |
| 11822-1103-0 | 11822-1103 | Rite Aid Corporation | 20 BLISTER PACK in 1 CARTON (11822-1103-0) / 1 GUM, CHEWING in 1 BLISTER PACK | August 29, 2023 |
| 11822-1103-1 | 11822-1103 | Rite Aid Corporation | 100 BLISTER PACK in 1 CARTON (11822-1103-1) / 1 GUM, CHEWING in 1 BLISTER PACK | June 26, 2023 |
| 0536-1362-06 | 0536-1362 | Rugby Laboratories | 50 BLISTER PACK in 1 CARTON (0536-1362-06) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-1362-25) | July 29, 2004 |
| 0536-1362-23 | 0536-1362 | Rugby Laboratories | 110 BLISTER PACK in 1 CARTON (0536-1362-23) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-1362-25) | July 29, 2004 |
| 0536-1362-34 | 0536-1362 | Rugby Laboratories | 20 BLISTER PACK in 1 CARTON (0536-1362-34) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-1362-25) | July 29, 2004 |
| 0536-1372-06 | 0536-1372 | Rugby Laboratories | 50 BLISTER PACK in 1 CARTON (0536-1372-06) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-1372-25) | July 29, 2004 |
| 0536-1372-23 | 0536-1372 | Rugby Laboratories | 110 BLISTER PACK in 1 CARTON (0536-1372-23) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-1372-25) | July 29, 2004 |
| 0536-1372-34 | 0536-1372 | Rugby Laboratories | 20 BLISTER PACK in 1 CARTON (0536-1372-34) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-1372-25) | July 29, 2004 |
| 0536-3029-06 | 0536-3029 | Rugby Laboratories | 50 BLISTER PACK in 1 CARTON (0536-3029-06) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3029-25) | March 15, 1999 |
| 0536-3029-23 | 0536-3029 | Rugby Laboratories | 110 BLISTER PACK in 1 CARTON (0536-3029-23) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3029-25) | March 15, 1999 |
| 0536-3029-34 | 0536-3029 | Rugby Laboratories | 20 BLISTER PACK in 1 CARTON (0536-3029-34) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3029-25) | March 15, 1999 |
| 0536-3030-06 | 0536-3030 | Rugby Laboratories | 50 BLISTER PACK in 1 CARTON (0536-3030-06) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3030-25) | March 19, 1999 |
| 0536-3030-23 | 0536-3030 | Rugby Laboratories | 110 BLISTER PACK in 1 CARTON (0536-3030-23) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3030-25) | March 19, 1999 |
| 0536-3112-01 | 0536-3112 | Rugby Laboratories | 100 BLISTER PACK in 1 CARTON (0536-3112-01) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3112-25) | December 29, 2008 |
| 0536-3112-37 | 0536-3112 | Rugby Laboratories | 40 BLISTER PACK in 1 CARTON (0536-3112-37) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3112-25) | December 29, 2008 |
| 0536-3113-01 | 0536-3113 | Rugby Laboratories | 100 BLISTER PACK in 1 CARTON (0536-3113-01) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3113-25) | December 29, 2008 |
| 0536-3113-37 | 0536-3113 | Rugby Laboratories | 40 BLISTER PACK in 1 CARTON (0536-3113-37) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3113-25) | December 29, 2008 |
| 0536-3404-01 | 0536-3404 | Rugby Laboratories | 100 BLISTER PACK in 1 CARTON (0536-3404-01) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3404-25) | July 8, 2009 |
| 0536-3405-01 | 0536-3405 | Rugby Laboratories | 100 BLISTER PACK in 1 CARTON (0536-3405-01) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3405-25) | July 8, 2009 |
| 21130-389-25 | 21130-389 | Safeway | 110 BLISTER PACK in 1 CARTON (21130-389-25) / 1 GUM, CHEWING in 1 BLISTER PACK | July 17, 2024 |
| 30142-671-11 | 30142-671 | The Kroger Co. | 110 BLISTER PACK in 1 CARTON (30142-671-11) / 1 GUM, CHEWING in 1 BLISTER PACK | June 3, 2022 |
| 30142-859-11 | 30142-859 | The Kroger Co. | 110 BLISTER PACK in 1 CARTON (30142-859-11) / 1 GUM, CHEWING in 1 BLISTER PACK | June 3, 2022 |
| 0363-0456-06 | 0363-0456 | Walgreen Company | 160 BLISTER PACK in 1 CARTON (0363-0456-06) / 1 GUM, CHEWING in 1 BLISTER PACK | February 22, 2007 |
| 0363-0456-60 | 0363-0456 | Walgreen Company | 20 BLISTER PACK in 1 CARTON (0363-0456-60) / 1 GUM, CHEWING in 1 BLISTER PACK | September 27, 2013 |
| 0363-0456-78 | 0363-0456 | Walgreen Company | 100 BLISTER PACK in 1 CARTON (0363-0456-78) / 1 GUM, CHEWING in 1 BLISTER PACK | October 27, 2006 |
| 0363-0919-06 | 0363-0919 | Walgreen Company | 160 BLISTER PACK in 1 CARTON (0363-0919-06) / 1 GUM, CHEWING in 1 BLISTER PACK | January 31, 2018 |
| 0363-0919-60 | 0363-0919 | Walgreen Company | 20 BLISTER PACK in 1 CARTON (0363-0919-60) / 1 GUM, CHEWING in 1 BLISTER PACK | March 18, 2014 |
| 0363-0919-78 | 0363-0919 | Walgreen Company | 100 BLISTER PACK in 1 CARTON (0363-0919-78) / 1 GUM, CHEWING in 1 BLISTER PACK | March 18, 2014 |
| 0363-1012-78 | 0363-1012 | Walgreen Company | 100 BLISTER PACK in 1 CARTON (0363-1012-78) / 1 GUM, CHEWING in 1 BLISTER PACK | February 2, 2018 |
| 0363-2309-78 | 0363-2309 | Walgreen Company | 100 BLISTER PACK in 1 CARTON (0363-2309-78) / 1 GUM, CHEWING in 1 BLISTER PACK | January 4, 2018 |
| 0363-7050-06 | 0363-7050 | Walgreen Company | 160 BLISTER PACK in 1 CARTON (0363-7050-06) / 1 GUM, CHEWING in 1 BLISTER PACK | June 16, 2023 |
| 0363-7103-06 | 0363-7103 | Walgreen Company | 160 BLISTER PACK in 1 CARTON (0363-7103-06) / 1 GUM, CHEWING in 1 BLISTER PACK | June 19, 2023 |
| 0363-7269-06 | 0363-7269 | Walgreen Company | 160 BLISTER PACK in 1 CARTON (0363-7269-06) / 1 GUM, CHEWING in 1 BLISTER PACK | May 28, 2019 |
| 0363-7269-60 | 0363-7269 | Walgreen Company | 20 BLISTER PACK in 1 CARTON (0363-7269-60) / 1 GUM, CHEWING in 1 BLISTER PACK | May 28, 2019 |
| 0363-7269-78 | 0363-7269 | Walgreen Company | 100 BLISTER PACK in 1 CARTON (0363-7269-78) / 1 GUM, CHEWING in 1 BLISTER PACK | May 24, 2019 |
| 0363-7971-06 | 0363-7971 | Walgreen Company | 160 BLISTER PACK in 1 CARTON (0363-7971-06) / 1 GUM, CHEWING in 1 BLISTER PACK | May 28, 2019 |
| 0363-7971-60 | 0363-7971 | Walgreen Company | 20 BLISTER PACK in 1 CARTON (0363-7971-60) / 1 GUM, CHEWING in 1 BLISTER PACK | May 28, 2019 |
| 0363-7971-78 | 0363-7971 | Walgreen Company | 100 BLISTER PACK in 1 CARTON (0363-7971-78) / 1 GUM, CHEWING in 1 BLISTER PACK | May 24, 2019 |
| 0363-3911-10 | 0363-3911 | Walgreens | 100 BLISTER PACK in 1 CARTON (0363-3911-10) / 1 GUM, CHEWING in 1 BLISTER PACK | October 30, 2020 |
| 0363-3911-16 | 0363-3911 | Walgreens | 160 BLISTER PACK in 1 CARTON (0363-3911-16) / 1 GUM, CHEWING in 1 BLISTER PACK | October 30, 2020 |
| 0363-9250-10 | 0363-9250 | Walgreens | 100 BLISTER PACK in 1 CARTON (0363-9250-10) / 1 GUM, CHEWING in 1 BLISTER PACK | January 29, 2021 |
| 0363-9250-16 | 0363-9250 | Walgreens | 160 BLISTER PACK in 1 CARTON (0363-9250-16) / 1 GUM, CHEWING in 1 BLISTER PACK | January 29, 2021 |
| 0363-9250-20 | 0363-9250 | Walgreens | 20 BLISTER PACK in 1 CARTON (0363-9250-20) / 1 GUM, CHEWING in 1 BLISTER PACK | January 29, 2021 |
| 0363-9290-30 | 0363-9290 | Walgreens | 300 BLISTER PACK in 1 CARTON (0363-9290-30) / 1 GUM, CHEWING in 1 BLISTER PACK | December 27, 2019 |
| 0363-9310-10 | 0363-9310 | Walgreens | 100 BLISTER PACK in 1 CARTON (0363-9310-10) / 1 GUM, CHEWING in 1 BLISTER PACK | October 30, 2020 |
| 0363-9310-16 | 0363-9310 | Walgreens | 160 BLISTER PACK in 1 CARTON (0363-9310-16) / 1 GUM, CHEWING in 1 BLISTER PACK | October 30, 2020 |
| 0363-9310-20 | 0363-9310 | Walgreens | 20 BLISTER PACK in 1 CARTON (0363-9310-20) / 1 GUM, CHEWING in 1 BLISTER PACK | October 30, 2020 |
| 0363-9350-30 | 0363-9350 | Walgreens | 300 BLISTER PACK in 1 CARTON (0363-9350-30) / 1 GUM, CHEWING in 1 BLISTER PACK | December 27, 2019 |
| 50090-6674 | 50090-6674 | A-S Medication Solutions | — | August 14, 2023 |
| 72288-518 | 72288-518 | Amazon.com Services LLC | — | August 12, 2026 |
| 72288-540 | 72288-540 | Amazon.com Services LLC | — | May 18, 2026 |
| 46122-719 | 46122-719 | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | — | September 30, 2022 |
| 46122-724 | 46122-724 | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | — | February 13, 2023 |
| 46122-733 | 46122-733 | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | — | September 30, 2022 |
| 51316-151 | 51316-151 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | — | May 26, 2026 |
| 51316-309 | 51316-309 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | — | May 27, 2026 |
| 55154-6818 | 55154-6818 | Cardinal Health 107, LLC | — | August 24, 2026 |
| 55910-918 | 55910-918 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | — | May 1, 2023 |
| 37808-611 | 37808-611 | H E B | — | July 31, 2023 |
| 37808-658 | 37808-658 | H E B | — | May 3, 2019 |
| 37808-682 | 37808-682 | H E B | — | May 6, 2019 |
| 37808-683 | 37808-683 | H E B | — | July 1, 2019 |
| 37808-711 | 37808-711 | H E B | — | May 2, 2019 |
| 37808-739 | 37808-739 | H E B | — | May 1, 2019 |
| 37808-781 | 37808-781 | H E B | — | April 12, 2019 |
| 37808-820 | 37808-820 | H E B | — | October 28, 2022 |
| 37808-821 | 37808-821 | H E B | — | October 28, 2022 |
| 37808-849 | 37808-849 | H E B | — | April 16, 2019 |
| 37808-909 | 37808-909 | H E B | — | June 26, 2019 |
| 42507-309 | 42507-309 | HyVee Inc | — | February 25, 2026 |
| 42507-343 | 42507-343 | HyVee Inc | — | February 25, 2026 |
| 30142-208 | 30142-208 | Kroger Company | — | April 25, 2017 |
| 30142-309 | 30142-309 | Kroger Company | — | April 25, 2017 |
| 30142-749 | 30142-749 | Kroger Company | — | March 12, 2019 |
| 30142-848 | 30142-848 | Kroger Company | — | June 5, 2019 |
| 72224-930 | 72224-930 | Lucy Goods, Inc. | — | April 25, 2025 |
| 72224-931 | 72224-931 | Lucy Goods, Inc. | — | April 25, 2025 |
| 63739-369 | 63739-369 | McKesson Corporation dba SKY Packaging | — | April 27, 2020 |
| 63739-371 | 63739-371 | McKesson Corporation dba SKY Packaging | — | April 27, 2020 |
| 41250-029 | 41250-029 | Meijer Distribution Inc | — | February 6, 2005 |
| 41250-170 | 41250-170 | Meijer Distribution Inc | — | February 1, 2005 |
| 41250-209 | 41250-209 | Meijer Distribution Inc | — | February 8, 2017 |
| 41250-456 | 41250-456 | Meijer Distribution Inc | — | October 31, 2006 |
| 41250-510 | 41250-510 | Meijer Distribution Inc | — | February 8, 2017 |
| 41250-529 | 41250-529 | Meijer Distribution Inc | — | June 30, 2020 |
| 41250-532 | 41250-532 | Meijer Distribution Inc | — | October 31, 2006 |
| 41250-689 | 41250-689 | Meijer Distribution Inc | — | December 18, 2019 |
| 41250-854 | 41250-854 | Meijer Distribution Inc | — | February 21, 1992 |
| 79481-0100 | 79481-0100 | Meijer, Inc. | — | June 15, 2023 |
| 79481-0103 | 79481-0103 | Meijer, Inc. | — | June 23, 2023 |
| 79481-0601 | 79481-0601 | Meijer, Inc. | — | August 3, 2023 |
| 79481-0755 | 79481-0755 | Meijer, Inc. | — | June 29, 2023 |
| 59726-592 | 59726-592 | P & L Development, LLC | — | March 1, 2024 |
| 59726-913 | 59726-913 | P & L Development, LLC | — | March 1, 2024 |
| 59726-929 | 59726-929 | P & L Development, LLC | — | March 1, 2024 |
| 59726-935 | 59726-935 | P & L Development, LLC | — | March 1, 2024 |
| 45802-651 | 45802-651 | Padagis Israel Pharmaceuticals Ltd | — | August 14, 2023 |
| 45802-827 | 45802-827 | Padagis Israel Pharmaceuticals Ltd | — | May 22, 2023 |
| 56062-019 | 56062-019 | Publix Super Markets Inc | — | June 11, 2026 |
| 56062-298 | 56062-298 | Publix Super Markets Inc | — | June 11, 2026 |
| 56062-646 | 56062-646 | Publix Super Markets Inc | — | June 11, 2026 |
| 56062-812 | 56062-812 | Publix Super Markets Inc | — | June 11, 2026 |
| 11822-0029 | 11822-0029 | Rite Aid Corporation | — | July 30, 2016 |
| 11822-0170 | 11822-0170 | Rite Aid Corporation | — | July 20, 2016 |
| 11822-0269 | 11822-0269 | Rite Aid Corporation | — | December 11, 2020 |
| 11822-0309 | 11822-0309 | Rite Aid Corporation | — | January 24, 2017 |
| 11822-0456 | 11822-0456 | Rite Aid Corporation | — | October 26, 2006 |
| 11822-0699 | 11822-0699 | Rite Aid Corporation | — | July 28, 2016 |
| 11822-0971 | 11822-0971 | Rite Aid Corporation | — | December 11, 2020 |
| 11822-1103 | 11822-1103 | Rite Aid Corporation | — | June 26, 2023 |
| 0536-1362 | 0536-1362 | Rugby Laboratories | — | July 29, 2004 |
| 0536-1372 | 0536-1372 | Rugby Laboratories | — | July 29, 2004 |
| 0536-3029 | 0536-3029 | Rugby Laboratories | — | March 15, 1999 |
| 0536-3030 | 0536-3030 | Rugby Laboratories | — | March 19, 1999 |
| 0536-3112 | 0536-3112 | Rugby Laboratories | — | December 29, 2008 |
| 0536-3113 | 0536-3113 | Rugby Laboratories | — | December 29, 2008 |
| 0536-3404 | 0536-3404 | Rugby Laboratories | — | July 8, 2009 |
| 0536-3405 | 0536-3405 | Rugby Laboratories | — | July 8, 2009 |
| 21130-389 | 21130-389 | Safeway | — | July 17, 2024 |
| 30142-671 | 30142-671 | The Kroger Co. | — | June 3, 2022 |
| 30142-859 | 30142-859 | The Kroger Co. | — | June 3, 2022 |
| 0363-0456 | 0363-0456 | Walgreen Company | — | October 27, 2006 |
| 0363-0919 | 0363-0919 | Walgreen Company | — | March 18, 2014 |
| 0363-1012 | 0363-1012 | Walgreen Company | — | February 2, 2018 |
| 0363-2309 | 0363-2309 | Walgreen Company | — | January 4, 2018 |
| 0363-7050 | 0363-7050 | Walgreen Company | — | June 16, 2023 |
| 0363-7103 | 0363-7103 | Walgreen Company | — | June 11, 2023 |
| 0363-7269 | 0363-7269 | Walgreen Company | — | May 24, 2019 |
| 0363-7971 | 0363-7971 | Walgreen Company | — | May 24, 2019 |
| 0363-3911 | 0363-3911 | Walgreens | — | October 30, 2020 |
| 0363-9250 | 0363-9250 | Walgreens | — | January 29, 2021 |
| 0363-9290 | 0363-9290 | Walgreens | — | December 27, 2019 |
| 0363-9310 | 0363-9310 | Walgreens | — | October 30, 2020 |
| 0363-9350 | 0363-9350 | Walgreens | — | December 27, 2019 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.