On this page
Aleve
Naproxen Sodium · Tablet
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Naproxen Sodium | 220 mg/1 | 849431 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 020204-002 | ALEVE | TABLET | NAPROXEN SODIUM | Over-the-counter | — | RLD RS |
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.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 90 | Labeling | Approved | March 10, 2026 | Standard |
| Supplement | 89 | Labeling | Approved | April 24, 2025 | Standard |
| Supplement | 88 | Labeling | Approved | September 11, 2024 | Standard |
| Supplement | 84 | Manufacturing (CMC) | Approved | April 4, 2023 | N/A |
| Supplement | 83 | Labeling | Approved | March 10, 2022 | Standard |
| Supplement | 81 | Labeling | Approved | April 1, 2021 | Standard |
| Supplement | 80 | Labeling | Approved | December 31, 2020 | Standard |
| Supplement | 79 | Labeling | Approved | December 31, 2020 | Standard |
| Supplement | 78 | Labeling | Approved | December 31, 2020 | Standard |
| Supplement | 77 | Labeling | Approved | December 31, 2020 | Standard |
| Supplement | 76 | Labeling | Approved | October 28, 2020 | Standard |
| Supplement | 72 | Labeling | Approved | May 8, 2020 | Standard |
| Supplement | 71 | Labeling | Approved | April 23, 2020 | Standard |
| Supplement | 70 | Labeling | Approved | March 2, 2020 | Standard |
| Supplement | 68 | Labeling | Approved | August 7, 2019 | Standard |
| Supplement | 67 | Labeling | Approved | July 23, 2019 | Standard |
| Supplement | 66 | Labeling | Approved | July 2, 2019 | Standard |
| Supplement | 65 | Labeling | Approved | May 13, 2019 | Standard |
| Supplement | 64 | Labeling | Approved | May 13, 2019 | Standard |
| Supplement | 63 | Labeling | Approved | May 13, 2019 | Standard |
| Supplement | 61 | Labeling | Approved | January 28, 2019 | Standard |
| Supplement | 62 | Labeling | Approved | January 3, 2019 | Standard |
| Supplement | 59 | Labeling | Approved | September 21, 2018 | Standard |
| Supplement | 58 | Labeling | Approved | August 28, 2018 | Standard |
| Supplement | 57 | Labeling | Approved | July 25, 2018 | Standard |
| Supplement | 56 | Labeling | Approved | June 11, 2018 | Standard |
| Supplement | 55 | Labeling | Approved | June 8, 2018 | Standard |
| Supplement | 54 | Labeling | Approved | March 29, 2018 | Standard |
| Supplement | 53 | Labeling | Approved | March 27, 2018 | Standard |
| Supplement | 52 | Labeling | Approved | September 14, 2017 | Standard |
| Supplement | 51 | Labeling | Approved | August 22, 2017 | Standard |
| Supplement | 49 | Manufacturing (CMC) | Approved | July 28, 2016 | Standard |
| Supplement | 48 | Manufacturing (CMC) | Approved | February 25, 2016 | Standard |
| Supplement | 46 | Manufacturing (CMC) | Approved | February 4, 2015 | Standard |
| Supplement | 44 | Labeling | Approved | April 18, 2013 | Standard |
| Supplement | 38 | Labeling | Approved | February 7, 2013 | Standard |
| Supplement | 43 | Manufacturing (CMC) | Approved | January 7, 2013 | Standard |
| Supplement | 42 | Manufacturing (CMC) | Approved | January 3, 2013 | Standard |
| Supplement | 41 | Manufacturing (CMC) | Approved | November 13, 2012 | Standard |
| Supplement | 40 | Labeling | Approved | March 16, 2012 | Standard |
| Supplement | 39 | Labeling | Approved | March 15, 2012 | Standard |
| Supplement | 37 | Labeling | Approved | April 8, 2011 | Standard |
| Supplement | 36 | Labeling | Approved | February 18, 2011 | Standard |
| Supplement | 35 | Labeling | Approved | November 3, 2010 | Standard |
| Supplement | 32 | Labeling | Approved | April 15, 2009 | Standard |
| Supplement | 31 | Labeling | Approved | November 24, 2008 | Standard |
| Supplement | 23 | Labeling | Approved | January 6, 2006 | Standard |
| Supplement | 21 | Labeling | Approved | May 4, 2005 | Standard |
| Supplement | 19 | Labeling | Approved | March 22, 2004 | Standard |
| Supplement | 16 | Manufacturing (CMC) | Approved | August 30, 2002 | Standard |
| Supplement | 8 | Labeling | Approved | March 19, 2002 | Standard |
| Supplement | 15 | Manufacturing (CMC) | Approved | December 21, 2001 | Standard |
| Supplement | 14 | Manufacturing (CMC) | Approved | March 27, 2001 | Standard |
| Supplement | 7 | Labeling | Approved | March 6, 2001 | Standard |
| Supplement | 13 | Manufacturing (CMC) | Approved | January 3, 2001 | Standard |
| Supplement | 10 | Labeling | Approved | August 23, 2000 | Standard |
| Supplement | 12 | Manufacturing (CMC) | Approved | June 7, 2000 | Standard |
| Supplement | 11 | Manufacturing (CMC) | Approved | May 11, 2000 | Standard |
| Supplement | 6 | Manufacturing (CMC) | Approved | November 20, 1998 | Standard |
| Supplement | 5 | Manufacturing (CMC) | Approved | April 16, 1998 | Standard |
Review documents
- 0 · Supplement · March 12, 2026
- 0 · Supplement · March 12, 2026
- 0 · Supplement · May 1, 2025
- 0 · Supplement · May 1, 2025
- 0 · Supplement · September 16, 2024
- 0 · Supplement · September 16, 2024
- 0 · Supplement · June 13, 2023
- 0 · Supplement · June 13, 2023
- 0 · Supplement · March 15, 2022
- 0 · Supplement · March 11, 2022
- 0 · Supplement · April 23, 2021
- 0 · Supplement · April 19, 2021
- 0 · Supplement · April 19, 2021
- 0 · Supplement · April 19, 2021
- 0 · Supplement · April 19, 2021
- 0 · Supplement · April 5, 2021
- 0 · Supplement · February 23, 2021
- 0 · Supplement · January 4, 2021
- 0 · Supplement · January 4, 2021
- 0 · Supplement · January 4, 2021
- 0 · Supplement · January 4, 2021
- 0 · Supplement · November 2, 2020
- 0 · Supplement · August 17, 2020
- 0 · Supplement · August 3, 2020
- 0 · Supplement · May 11, 2020
- 0 · Supplement · April 24, 2020
- 0 · Supplement · March 4, 2020
- 0 · Supplement · March 4, 2020
- 0 · Supplement · August 13, 2019
- 0 · Supplement · August 12, 2019
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260408). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Purpose
openFDA Drug LabelingPurposes Pain reliever/ fever reducer
Dosage and Administration
openFDA Drug LabelingDirections Directions · do not take more than directed · the smallest effective dose should be used · drink a full glass of water with each dose Adults and children 12 years and older take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period Children under 12 years of age ask a doctor
Warnings
openFDA Drug LabelingAllergy alert : Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may Include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are under a doctor's care for any serious conidtion taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding , ask a healthcare professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems un the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do Not Use
openFDA Drug LabelingDo not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug
Stop Use
openFDA Drug LabelingStop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear
Active Ingredient
openFDA Drug LabelingActive ingredient (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug Purposes Pain reliever/ fever reducer
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: NAPROXEN SODIUM. 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 |
|---|---|---|---|---|
| 0280-0111-01 | 0280-0111 | Bayer HealthCare LLC. | 10 TABLET in 1 BOTTLE (0280-0111-01) | March 25, 2024 |
| 0280-0111-02 | 0280-0111 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0111-02) / 110 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0111-03 | 0280-0111 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0111-03) / 200 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0111-04 | 0280-0111 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0111-04) / 24 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0111-05 | 0280-0111 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0111-05) / 250 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0111-06 | 0280-0111 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0111-06) / 50 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0111-07 | 0280-0111 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0111-07) / 90 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0112-01 | 0280-0112 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0112-01) / 175 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0112-02 | 0280-0112 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0112-02) / 24 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0112-03 | 0280-0112 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0112-03) / 50 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0112-04 | 0280-0112 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0112-04) / 90 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0113-01 | 0280-0113 | Bayer HealthCare LLC. | 10 TABLET in 1 BOTTLE (0280-0113-01) | March 25, 2024 |
| 0280-0113-02 | 0280-0113 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0113-02) / 24 TABLET in 1 BOTTLE | April 4, 2024 |
| 0280-0113-03 | 0280-0113 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0113-03) / 270 TABLET in 1 BOTTLE | April 4, 2024 |
| 0280-0113-04 | 0280-0113 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0113-04) / 50 TABLET in 1 BOTTLE | April 4, 2024 |
| 0280-0113-05 | 0280-0113 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0113-05) / 90 TABLET in 1 BOTTLE | April 4, 2024 |
| 0280-0113-06 | 0280-0113 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0113-06) / 110 TABLET in 1 BOTTLE | April 4, 2024 |
| 0280-0114-01 | 0280-0114 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0114-01) / 200 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0114-02 | 0280-0114 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0114-02) / 24 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0114-03 | 0280-0114 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0114-03) / 50 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0114-04 | 0280-0114 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0114-04) / 90 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0114-05 | 0280-0114 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0114-05) / 110 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0114-08 | 0280-0114 | Bayer HealthCare LLC. | 270 TABLET in 1 BOTTLE (0280-0114-08) | March 25, 2024 |
| 0280-0115-01 | 0280-0115 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0115-01) / 270 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0115-02 | 0280-0115 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0115-02) / 50 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0115-03 | 0280-0115 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-0115-03) / 24 TABLET in 1 BOTTLE | March 25, 2024 |
| 0280-0130-01 | 0280-0130 | Bayer HealthCare LLC. | 90 TABLET in 1 BOTTLE (0280-0130-01) | March 25, 2024 |
| 0280-0130-02 | 0280-0130 | Bayer HealthCare LLC. | 110 TABLET in 1 BOTTLE (0280-0130-02) | March 25, 2024 |
| 0280-0131-01 | 0280-0131 | Bayer HealthCare LLC. | 200 TABLET in 1 BOTTLE (0280-0131-01) | March 25, 2024 |
| 0280-6000-01 | 0280-6000 | Bayer HealthCare LLC. | 24 TABLET in 1 BOTTLE (0280-6000-01) | February 26, 2014 |
| 0280-6000-02 | 0280-6000 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6000-02) / 200 TABLET in 1 BOTTLE | March 26, 2014 |
| 0280-6000-03 | 0280-6000 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6000-03) / 130 TABLET in 1 BOTTLE | February 26, 2014 |
| 0280-6000-04 | 0280-6000 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6000-04) / 225 TABLET in 1 BOTTLE | February 26, 2014 |
| 0280-6000-05 | 0280-6000 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6000-05) / 36 TABLET in 1 BOTTLE | February 26, 2014 |
| 0280-6000-06 | 0280-6000 | Bayer HealthCare LLC. | 1 BLISTER PACK in 1 CARTON (0280-6000-06) / 6 TABLET in 1 BLISTER PACK | February 26, 2014 |
| 0280-6000-07 | 0280-6000 | Bayer HealthCare LLC. | 48 TABLET in 1 POUCH (0280-6000-07) | February 26, 2014 |
| 0280-6000-08 | 0280-6000 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6000-08) / 65 TABLET in 1 BOTTLE | February 26, 2014 |
| 0280-6000-09 | 0280-6000 | Bayer HealthCare LLC. | 1 TABLET in 1 POUCH (0280-6000-09) | July 1, 2020 |
| 0280-6000-12 | 0280-6000 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6000-12) / 90 TABLET in 1 BOTTLE | July 1, 2021 |
| 0280-6000-16 | 0280-6000 | Bayer HealthCare LLC. | 1 TABLET in 1 POUCH (0280-6000-16) | July 1, 2021 |
| 0280-6000-24 | 0280-6000 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6000-24) / 24 TABLET in 1 BOTTLE | February 26, 2014 |
| 0280-6000-27 | 0280-6000 | Bayer HealthCare LLC. | 270 TABLET in 1 BOTTLE (0280-6000-27) | July 1, 2021 |
| 0280-6000-32 | 0280-6000 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6000-32) / 320 TABLET in 1 BOTTLE | February 26, 2014 |
| 0280-6000-50 | 0280-6000 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6000-50) / 50 TABLET in 1 BOTTLE | February 26, 2014 |
| 0280-6000-70 | 0280-6000 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6000-70) / 150 TABLET in 1 BOTTLE | March 18, 2016 |
| 0280-6010-01 | 0280-6010 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6010-01) / 100 TABLET in 1 BOTTLE | July 26, 2002 |
| 0280-6010-02 | 0280-6010 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6010-02) / 130 TABLET in 1 BOTTLE | July 26, 2002 |
| 0280-6010-03 | 0280-6010 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6010-03) / 150 TABLET in 1 BOTTLE | July 26, 2002 |
| 0280-6010-04 | 0280-6010 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6010-04) / 36 TABLET in 1 BOTTLE | July 26, 2002 |
| 0280-6010-05 | 0280-6010 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6010-05) / 65 TABLET in 1 BOTTLE | July 26, 2002 |
| 0280-6010-06 | 0280-6010 | Bayer HealthCare LLC. | 225 TABLET in 1 BOTTLE (0280-6010-06) | July 26, 2002 |
| 0280-6010-07 | 0280-6010 | Bayer HealthCare LLC. | 270 TABLET in 1 BOTTLE (0280-6010-07) | July 26, 2002 |
| 0280-6010-09 | 0280-6010 | Bayer HealthCare LLC. | 90 TABLET in 1 BOTTLE (0280-6010-09) | July 26, 2002 |
| 0280-6010-10 | 0280-6010 | Bayer HealthCare LLC. | 1 BOTTLE in 1 TRAY (0280-6010-10) / 10 TABLET in 1 BOTTLE | July 26, 2002 |
| 0280-6010-24 | 0280-6010 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6010-24) / 24 TABLET in 1 BOTTLE | July 26, 2002 |
| 0280-6010-50 | 0280-6010 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6010-50) / 50 TABLET in 1 BOTTLE | July 26, 2002 |
| 0280-6050-01 | 0280-6050 | Bayer HealthCare LLC. | 100 TABLET in 1 BOTTLE (0280-6050-01) | November 11, 2013 |
| 0280-6050-02 | 0280-6050 | Bayer HealthCare LLC. | 24 TABLET in 1 BOTTLE (0280-6050-02) | June 11, 2020 |
| 0280-6050-03 | 0280-6050 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6050-03) / 130 TABLET in 1 BOTTLE | November 11, 2013 |
| 0280-6050-04 | 0280-6050 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6050-04) / 150 TABLET in 1 BOTTLE | November 11, 2013 |
| 0280-6050-05 | 0280-6050 | Bayer HealthCare LLC. | 110 TABLET in 1 BOTTLE (0280-6050-05) | July 1, 2021 |
| 0280-6050-06 | 0280-6050 | Bayer HealthCare LLC. | 90 TABLET in 1 BOTTLE (0280-6050-06) | July 1, 2021 |
| 0280-6050-27 | 0280-6050 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6050-27) / 270 TABLET in 1 BOTTLE | November 11, 2013 |
| 0280-6050-50 | 0280-6050 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-6050-50) / 50 TABLET in 1 BOTTLE | November 11, 2013 |
| 0280-6060-20 | 0280-6060 | Bayer HealthCare LLC. | 200 TABLET in 1 BOTTLE (0280-6060-20) | September 9, 2014 |
| 0280-6060-25 | 0280-6060 | Bayer HealthCare LLC. | 250 TABLET in 1 BOTTLE (0280-6060-25) | September 9, 2014 |
| 0280-6060-32 | 0280-6060 | Bayer HealthCare LLC. | 320 TABLET in 1 BOTTLE (0280-6060-32) | September 9, 2014 |
| 0280-8252-10 | 0280-8252 | Bayer HealthCare LLC. | 10 TABLET in 1 BOTTLE (0280-8252-10) | September 11, 2024 |
| 0280-8252-24 | 0280-8252 | Bayer HealthCare LLC. | 1 BOTTLE in 1 CARTON (0280-8252-24) / 24 TABLET in 1 BOTTLE | April 24, 2025 |
| 66715-5103-0 | 66715-5103 | Lil' Drug Store Products, Inc | 30 POUCH in 1 BOX, UNIT-DOSE (66715-5103-0) / 2 TABLET in 1 POUCH | November 16, 2006 |
| 66715-6402-8 | 66715-6402 | Lil' Drug Store Products, Inc | 30 POUCH in 1 BOX, UNIT-DOSE (66715-6402-8) / 1 TABLET in 1 POUCH | April 19, 2022 |
| 66715-6502-2 | 66715-6502 | Lil' Drug Store Products, Inc | 2 POUCH in 1 CARTON (66715-6502-2) / 1 TABLET in 1 POUCH | May 6, 2022 |
| 66715-9702-2 | 66715-9702 | Lil' Drug Store Products, Inc | 2 POUCH in 1 CARTON (66715-9702-2) / 1 TABLET in 1 POUCH | January 1, 2000 |
| 66715-9702-3 | 66715-9702 | Lil' Drug Store Products, Inc | 3 POUCH in 1 CARTON (66715-9702-3) / 1 TABLET in 1 POUCH | January 1, 2000 |
| 67751-144-03 | 67751-144 | Navajo Manufacturing Company Inc | 1 POUCH in 1 CARTON (67751-144-03) / 1 TABLET in 1 POUCH | December 4, 2017 |
| 67751-144-04 | 67751-144 | Navajo Manufacturing Company Inc | 2 POUCH in 1 CARTON (67751-144-04) / 1 TABLET in 1 POUCH | December 4, 2017 |
| 67751-144-01 | 67751-144 | Navajo Manufacturing Company Inc. | 1 POUCH in 1 CARTON (67751-144-01) / 1 TABLET in 1 POUCH | September 17, 2016 |
| 67751-144-02 | 67751-144 | Navajo Manufacturing Company Inc. | 1 POUCH in 1 CARTON (67751-144-02) / 2 TABLET in 1 POUCH | September 17, 2016 |
| 67751-144-06 | 67751-144 | Navajo Manufacturing Company Inc. | 3 POUCH in 1 CARTON (67751-144-06) / 1 TABLET in 1 POUCH | April 22, 2025 |
| 70264-011-01 | 70264-011 | R J General Corporation | 50 POUCH in 1 CARTON (70264-011-01) / 1 TABLET in 1 POUCH | February 26, 2014 |
| 85237-1832-1 | 85237-1832 | Select Consumer Group | 1 POUCH in 1 BLISTER PACK (85237-1832-1) / 1 TABLET in 1 POUCH (85237-1832-0) | March 25, 2024 |
| 85237-1832-2 | 85237-1832 | Select Consumer Group | 2 POUCH in 1 BLISTER PACK (85237-1832-2) / 1 TABLET in 1 POUCH | December 24, 2025 |
| 85237-1832-4 | 85237-1832 | Select Consumer Group | 25 POUCH in 1 BOX, UNIT-DOSE (85237-1832-4) / 1 TABLET in 1 POUCH | December 24, 2025 |
| 85237-1832-6 | 85237-1832 | Select Consumer Group | 50 POUCH in 1 BOX, UNIT-DOSE (85237-1832-6) / 1 TABLET in 1 POUCH | December 24, 2025 |
| 85237-1832-7 | 85237-1832 | Select Consumer Group | 3 POUCH in 1 BLISTER PACK (85237-1832-7) / 1 TABLET in 1 POUCH (85237-1832-0) | December 24, 2025 |
| 0280-0111 | 0280-0111 | Bayer HealthCare LLC. | — | April 4, 2023 |
| 0280-0112 | 0280-0112 | Bayer HealthCare LLC. | — | April 4, 2023 |
| 0280-0113 | 0280-0113 | Bayer HealthCare LLC. | — | April 4, 2023 |
| 0280-0114 | 0280-0114 | Bayer HealthCare LLC. | — | April 4, 2023 |
| 0280-0115 | 0280-0115 | Bayer HealthCare LLC. | — | April 4, 2023 |
| 0280-0130 | 0280-0130 | Bayer HealthCare LLC. | — | April 4, 2023 |
| 0280-0131 | 0280-0131 | Bayer HealthCare LLC. | — | April 4, 2023 |
| 0280-6000 | 0280-6000 | Bayer HealthCare LLC. | — | February 26, 2014 |
| 0280-6010 | 0280-6010 | Bayer HealthCare LLC. | — | July 26, 2002 |
| 0280-6050 | 0280-6050 | Bayer HealthCare LLC. | — | November 11, 2013 |
| 0280-6060 | 0280-6060 | Bayer HealthCare LLC. | — | July 26, 2002 |
| 0280-8252 | 0280-8252 | Bayer HealthCare LLC. | — | April 4, 2023 |
| 66715-5103 | 66715-5103 | Lil' Drug Store Products, Inc | — | November 16, 2006 |
| 66715-6402 | 66715-6402 | Lil' Drug Store Products, Inc | — | April 19, 2022 |
| 66715-6502 | 66715-6502 | Lil' Drug Store Products, Inc | — | May 6, 2022 |
| 66715-9702 | 66715-9702 | Lil' Drug Store Products, Inc | — | January 1, 2000 |
| 67751-144 | 67751-144 | Navajo Manufacturing Company Inc. | — | September 17, 2016 |
| 70264-011 | 70264-011 | R J General Corporation | — | February 26, 2014 |
| 85237-1832 | 85237-1832 | Select Consumer Group | — | April 4, 2023 |
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 · 12 sections on this page.