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Nicorette
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 |
|---|---|---|---|---|---|---|---|
| 020066-002 | NICORETTE | GUM, CHEWING | NICOTINE POLACRILEX | Over-the-counter | — | RLD RS | |
| 020066-003 | NICORETTE (MINT) | GUM, CHEWING | NICOTINE POLACRILEX | Over-the-counter | — | RLD | |
| 020066-004 | NICORETTE | GUM, CHEWING | NICOTINE POLACRILEX | Over-the-counter | — | RLD |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Patents and exclusivity
Source: Orange Book| Patent | Expires | Product | Substance | Use code | Submitted |
|---|---|---|---|---|---|
| 8323683 | April 30, 2028 | 002 | No | January 3, 2013 |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 66 | Labeling | Approved | January 3, 2024 | Standard |
| Supplement | 65 | Labeling | Approved | April 23, 2021 | Standard |
| Supplement | 64 | Labeling | Approved | November 15, 2019 | Standard |
| Supplement | 62 | Labeling | Approved | November 14, 2018 | Standard |
| Supplement | 61 | Labeling | Approved | June 5, 2018 | Standard |
| Supplement | 60 | Labeling | Approved | December 11, 2017 | Standard |
| Supplement | 59 | Manufacturing (CMC) | Approved | September 11, 2017 | N/A |
| Supplement | 57 | Labeling | Approved | September 30, 2015 | Standard |
| Supplement | 55 | Labeling | Approved | October 30, 2014 | Standard |
| Supplement | 54 | Labeling | Approved | June 11, 2014 | Standard |
| Supplement | 53 | Labeling | Approved | June 11, 2014 | Standard |
| Supplement | 51 | Manufacturing (CMC) | Approved | April 17, 2014 | Standard |
| Supplement | 49 | Labeling | Approved | October 30, 2013 | Standard |
| Supplement | 48 | Manufacturing (CMC) | Approved | August 1, 2012 | Standard |
| Supplement | 46 | Labeling | Approved | July 16, 2012 | Standard |
| Supplement | 42 | Labeling | Approved | February 15, 2012 | Standard |
| Supplement | 41 | Labeling | Approved | February 1, 2012 | Standard |
| Supplement | 38 | Labeling | Approved | September 27, 2011 | Standard |
| Supplement | 37 | Labeling | Approved | May 17, 2011 | Standard |
| Supplement | 32 | Manufacturing (CMC) | Approved | April 21, 2010 | N/A |
| Supplement | 33 | Efficacy | Approved | May 6, 2009 | Unknown |
| Supplement | 31 | Manufacturing (CMC) | Approved | June 13, 2008 | N/A |
| Supplement | 30 | Manufacturing (CMC) | Approved | June 26, 2007 | N/A |
| Supplement | 24 | Manufacturing (CMC) | Approved | May 4, 2006 | N/A |
| Supplement | 23 | Manufacturing (CMC) | Approved | December 2, 2005 | Standard |
| Supplement | 17 | Labeling | Approved | June 23, 2004 | Standard |
| Supplement | 19 | Manufacturing (CMC) | Approved | June 18, 2004 | Standard |
| Supplement | 16 | Manufacturing (CMC) | Approved | April 23, 2004 | Standard |
| Supplement | 14 | Manufacturing (CMC) | Approved | November 15, 2002 | Standard |
| Supplement | 13 | Labeling | Approved | August 9, 2002 | Standard |
| Supplement | 8 | Labeling | Approved | August 24, 2001 | Standard |
| Supplement | 10 | Manufacturing (CMC) | Approved | September 25, 2000 | Standard |
| Supplement | 7 | Efficacy | Approved | December 23, 1998 | Unknown |
| Supplement | 6 | Manufacturing (CMC) | Approved | November 4, 1998 | Standard |
| Supplement | 4 | Efficacy | Approved | February 9, 1996 | Standard |
| Supplement | 3 | Manufacturing (CMC) | Approved | March 22, 1993 | Standard |
| Supplement | 1 | Manufacturing (CMC) | Approved | March 22, 1993 | Standard |
| Original application | 1 | Type 5 - New Formulation or New Manufacturer | Approved | June 8, 1992 | Standard |
Review documents
- 0 · Supplement · January 4, 2024
- 0 · Supplement · January 4, 2024
- 0 · Supplement · May 13, 2021
- 0 · Supplement · April 27, 2021
- 0 · Supplement · November 20, 2019
- 0 · Supplement · November 20, 2019
- 0 · Supplement · November 23, 2018
- 0 · Supplement · November 21, 2018
- 0 · Supplement · June 21, 2018
- 0 · Supplement · June 14, 2018
- 0 · Supplement · December 18, 2017
- 0 · Supplement · December 18, 2017
- 0 · Supplement · October 10, 2017
- 0 · Supplement · November 2, 2015
- 0 · Supplement · October 2, 2015
- 0 · Supplement · November 7, 2014
- 0 · Supplement · November 3, 2014
- 0 · Supplement · August 5, 2014
- 0 · Supplement · August 5, 2014
- 0 · Supplement · June 12, 2014
- 0 · Supplement · June 12, 2014
- 0 · Supplement · January 16, 2014
- 0 · Supplement · November 7, 2013
- 0 · Supplement · October 31, 2013
- 0 · Supplement · July 18, 2012
- 0 · Supplement · March 28, 2012
- 0 · Supplement · March 27, 2012
- 0 · Supplement · February 17, 2012
- 0 · Supplement · February 3, 2012
- 0 · Supplement · September 29, 2011
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240813). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse 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 your 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 a pharmacist before use if you are using a non-nicotine stop smoking drug taking a 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 (For Cinnamon Surge) 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.
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 (For Cinnamon Surge) 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) Nicotine polacrilex (equal to 2 mg nicotine) Nicotine polacrilex (equal to 4 mg nicotine)
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 |
|---|---|---|---|---|
| 0135-0157-07 | 0135-0157 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0157-07) / 110 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0157-10 | 0135-0157 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0157-10) / 170 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0157-11 | 0135-0157 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0157-11) / 200 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0158-07 | 0135-0158 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0158-07) / 110 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0158-10 | 0135-0158 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0158-10) / 170 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0158-11 | 0135-0158 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0158-11) / 200 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0229-05 | 0135-0229 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0229-05) / 170 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0230-03 | 0135-0230 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0230-03) / 50 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0230-05 | 0135-0230 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0230-05) / 170 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0241-02 | 0135-0241 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0241-02) / 100 GUM, CHEWING in 1 BLISTER PACK | September 14, 2009 |
| 0135-0241-05 | 0135-0241 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0241-05) / 160 GUM, CHEWING in 1 BLISTER PACK | September 14, 2009 |
| 0135-0241-06 | 0135-0241 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0241-06) / 20 GUM, CHEWING in 1 BLISTER PACK | September 14, 2009 |
| 0135-0241-08 | 0135-0241 | Haleon US Holdings LLC | 20 GUM, CHEWING in 1 CARTON (0135-0241-08) | September 14, 2009 |
| 0135-0241-17 | 0135-0241 | Haleon US Holdings LLC | 2 CARTON in 1 PACKAGE (0135-0241-17) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK | August 1, 2014 |
| 0135-0241-18 | 0135-0241 | Haleon US Holdings LLC | 12 BLISTER PACK in 1 CARTON (0135-0241-18) / 10 GUM, CHEWING in 1 BLISTER PACK | September 1, 2018 |
| 0135-0241-19 | 0135-0241 | Haleon US Holdings LLC | 18 BLISTER PACK in 1 CARTON (0135-0241-19) / 10 GUM, CHEWING in 1 BLISTER PACK | December 3, 2018 |
| 0135-0242-02 | 0135-0242 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0242-02) / 100 GUM, CHEWING in 1 BLISTER PACK | September 14, 2009 |
| 0135-0242-05 | 0135-0242 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0242-05) / 160 GUM, CHEWING in 1 BLISTER PACK | September 14, 2009 |
| 0135-0242-06 | 0135-0242 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0242-06) / 20 GUM, CHEWING in 1 BLISTER PACK | September 14, 2009 |
| 0135-0242-08 | 0135-0242 | Haleon US Holdings LLC | 20 GUM, CHEWING in 1 CARTON (0135-0242-08) | September 14, 2009 |
| 0135-0242-11 | 0135-0242 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0242-11) / 10 GUM, CHEWING in 1 BLISTER PACK | September 14, 2009 |
| 0135-0242-17 | 0135-0242 | Haleon US Holdings LLC | 2 CARTON in 1 PACKAGE (0135-0242-17) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK | August 1, 2014 |
| 0135-0242-18 | 0135-0242 | Haleon US Holdings LLC | 12 BLISTER PACK in 1 CARTON (0135-0242-18) / 10 GUM, CHEWING in 1 BLISTER PACK | September 1, 2018 |
| 0135-0242-19 | 0135-0242 | Haleon US Holdings LLC | 18 BLISTER PACK in 1 CARTON (0135-0242-19) / 10 GUM, CHEWING in 1 BLISTER PACK | December 3, 2018 |
| 0135-0355-03 | 0135-0355 | Haleon US Holdings LLC | 16 BLISTER PACK in 1 CARTON (0135-0355-03) / 10 GUM, CHEWING in 1 BLISTER PACK | September 13, 2017 |
| 0135-0466-01 | 0135-0466 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0466-01) / 20 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0466-02 | 0135-0466 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0466-02) / 100 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0466-03 | 0135-0466 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0466-03) / 190 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0466-05 | 0135-0466 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0466-05) / 160 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0466-07 | 0135-0466 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0466-07) / 40 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0466-08 | 0135-0466 | Haleon US Holdings LLC | 20 GUM, CHEWING in 1 CARTON (0135-0466-08) | June 29, 2009 |
| 0135-0467-01 | 0135-0467 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0467-01) / 20 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0467-02 | 0135-0467 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0467-02) / 100 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0467-05 | 0135-0467 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0467-05) / 160 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0467-07 | 0135-0467 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0467-07) / 40 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0467-08 | 0135-0467 | Haleon US Holdings LLC | 20 GUM, CHEWING in 1 CARTON (0135-0467-08) | June 29, 2009 |
| 0135-0474-01 | 0135-0474 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0474-01) / 20 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0474-02 | 0135-0474 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0474-02) / 100 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0474-05 | 0135-0474 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0474-05) / 160 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0474-08 | 0135-0474 | Haleon US Holdings LLC | 20 GUM, CHEWING in 1 CARTON (0135-0474-08) | June 29, 2009 |
| 0135-0474-17 | 0135-0474 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0474-17) / 10 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0474-18 | 0135-0474 | Haleon US Holdings LLC | 2 CARTON in 1 PACKAGE (0135-0474-18) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK | August 1, 2014 |
| 0135-0474-19 | 0135-0474 | Haleon US Holdings LLC | 12 BLISTER PACK in 1 CARTON (0135-0474-19) / 10 GUM, CHEWING in 1 BLISTER PACK | September 1, 2018 |
| 0135-0474-20 | 0135-0474 | Haleon US Holdings LLC | 18 BLISTER PACK in 1 CARTON (0135-0474-20) / 10 GUM, CHEWING in 1 BLISTER PACK | December 3, 2018 |
| 0135-0475-01 | 0135-0475 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0475-01) / 20 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0475-02 | 0135-0475 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0475-02) / 100 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0475-05 | 0135-0475 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0475-05) / 160 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0475-08 | 0135-0475 | Haleon US Holdings LLC | 20 GUM, CHEWING in 1 CARTON (0135-0475-08) | June 29, 2009 |
| 0135-0475-17 | 0135-0475 | Haleon US Holdings LLC | 1 BLISTER PACK in 1 CARTON (0135-0475-17) / 10 GUM, CHEWING in 1 BLISTER PACK | June 29, 2009 |
| 0135-0475-18 | 0135-0475 | Haleon US Holdings LLC | 2 CARTON in 1 PACKAGE (0135-0475-18) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK | August 1, 2014 |
| 0135-0475-19 | 0135-0475 | Haleon US Holdings LLC | 12 BLISTER PACK in 1 CARTON (0135-0475-19) / 10 GUM, CHEWING in 1 BLISTER PACK | September 1, 2018 |
| 0135-0475-20 | 0135-0475 | Haleon US Holdings LLC | 18 BLISTER PACK in 1 CARTON (0135-0475-20) / 10 GUM, CHEWING in 1 BLISTER PACK | December 3, 2018 |
| 0135-0532-02 | 0135-0532 | Haleon US Holdings LLC | 10 BLISTER PACK in 1 CARTON (0135-0532-02) / 10 GUM, CHEWING in 1 BLISTER PACK | September 13, 2017 |
| 0135-0532-03 | 0135-0532 | Haleon US Holdings LLC | 16 BLISTER PACK in 1 CARTON (0135-0532-03) / 10 GUM, CHEWING in 1 BLISTER PACK | September 13, 2017 |
| 0135-0532-12 | 0135-0532 | Haleon US Holdings LLC | 2 CARTON in 1 PACKAGE (0135-0532-12) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK | March 1, 2018 |
| 0135-0532-13 | 0135-0532 | Haleon US Holdings LLC | 12 BLISTER PACK in 1 CARTON (0135-0532-13) / 10 GUM, CHEWING in 1 BLISTER PACK | September 1, 2018 |
| 0135-0532-14 | 0135-0532 | Haleon US Holdings LLC | 18 BLISTER PACK in 1 CARTON (0135-0532-14) / 10 GUM, CHEWING in 1 BLISTER PACK | December 3, 2018 |
| 0135-0533-02 | 0135-0533 | Haleon US Holdings LLC | 10 BLISTER PACK in 1 CARTON (0135-0533-02) / 10 GUM, CHEWING in 1 BLISTER PACK | September 13, 2017 |
| 0135-0533-12 | 0135-0533 | Haleon US Holdings LLC | 2 CARTON in 1 PACKAGE (0135-0533-12) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK | March 1, 2018 |
| 0135-0533-13 | 0135-0533 | Haleon US Holdings LLC | 12 BLISTER PACK in 1 CARTON (0135-0533-13) / 10 GUM, CHEWING in 1 BLISTER PACK | September 1, 2018 |
| 0135-0533-14 | 0135-0533 | Haleon US Holdings LLC | 18 BLISTER PACK in 1 CARTON (0135-0533-14) / 10 GUM, CHEWING in 1 BLISTER PACK | December 3, 2018 |
| 0135-0157 | 0135-0157 | Haleon US Holdings LLC | — | June 29, 2009 |
| 0135-0158 | 0135-0158 | Haleon US Holdings LLC | — | June 29, 2009 |
| 0135-0229 | 0135-0229 | Haleon US Holdings LLC | — | June 29, 2009 |
| 0135-0230 | 0135-0230 | Haleon US Holdings LLC | — | June 29, 2009 |
| 0135-0241 | 0135-0241 | Haleon US Holdings LLC | — | September 14, 2009 |
| 0135-0242 | 0135-0242 | Haleon US Holdings LLC | — | September 14, 2009 |
| 0135-0355 | 0135-0355 | Haleon US Holdings LLC | — | September 13, 2017 |
| 0135-0466 | 0135-0466 | Haleon US Holdings LLC | — | June 29, 2009 |
| 0135-0467 | 0135-0467 | Haleon US Holdings LLC | — | June 29, 2009 |
| 0135-0474 | 0135-0474 | Haleon US Holdings LLC | — | June 29, 2009 |
| 0135-0475 | 0135-0475 | Haleon US Holdings LLC | — | June 29, 2009 |
| 0135-0532 | 0135-0532 | Haleon US Holdings LLC | — | September 13, 2017 |
| 0135-0533 | 0135-0533 | Haleon US Holdings LLC | — | September 13, 2017 |
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 |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 13 sections on this page.