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Good Sense Naproxen Sodium

Naproxen Sodium · Tablet, Film Coated

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Good Sense Naproxen Sodium
Generic name
Naproxen Sodium
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
L. Perrigo Company
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
7
Packages
28
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Diphenhydramine Hydrochloride 25 mg/1 1049630 View
Naproxen Sodium 220 mg/1 849431 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
35

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-Inflammatory Agents EPC All 251 members
Cyclooxygenase Inhibitors [MoA] MoA All 251 members
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members
Non-Steroidal [CS] CS All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC] EPC All 251 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
074661
Application type
ANDA · Abbreviated New Drug Application
Approval date
January 13, 1997
Sponsor
PERRIGO
Products on application
1
Submissions recorded
16
Products approved under application 074661.
Product Trade name Form Strength Ingredient Status TE Flags
074661-001 NAPROXEN SODIUM TABLET NAPROXEN SODIUM Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 074661.
Type No. Action Status Date Review
Supplement 40 Labeling Approved November 12, 2014 —
Supplement 62 Labeling Approved October 25, 2014 Standard
Supplement 58 Labeling Approved October 25, 2014 Standard
Supplement 54 Labeling Approved October 25, 2014 Standard
Supplement 44 Labeling Approved January 19, 2012 —
Supplement 43 Labeling Approved September 7, 2010 —
Supplement 28 Labeling Approved December 19, 2006 —
Supplement 27 Labeling Approved March 13, 2006 —
Supplement 10 Manufacturing (CMC) Approved November 20, 2002 —
Supplement 9 Manufacturing (CMC) Approved November 20, 2002 —
Supplement 8 Labeling Approved December 10, 2001 —
Supplement 5 Manufacturing (CMC) Approved August 25, 1999 —
Supplement 4 Labeling Approved February 19, 1999 —
Supplement 3 Manufacturing (CMC) Approved August 28, 1998 —
Supplement 1 Manufacturing (CMC) Approved August 11, 1997 —
Original application 1 Approved January 13, 1997 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260511). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260511 HUMAN OTC DRUG · 20260511 HUMAN OTC DRUG · 20250826 HUMAN OTC DRUG · 20240219

Indications and Usage

openFDA Drug Labeling

Uses • 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

Purposes Nighttime sleep-aid Pain reliever

Dosage and Administration

openFDA Drug Labeling

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: • ask a doctor

Warnings Allergy 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 • unless you have time for a full night’s sleep • in children under 12 years of age • right before or after heart surgery • with any other product containing diphenhydramine, even one used on skin • if you have sleeplessness without pain Ask a doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • 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 a breathing problem such as emphysema or chronic bronchitis • you have glaucoma • you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers, or any other sleep-aid • 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 antihistamines • taking any other drug When using this product • drowsiness will occur • avoid alcoholic drinks • do not drive a motor vehicle or operate machinery • 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 • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • redness or swelling is present in the painful area • any new symptoms appear • you have difficulty swallowing • it feels like the pill is stuck in your throat If pregnant or breast feeding ask a health 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 in 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 (1-800-222-1222).

Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • unless you have time for a full night’s sleep • in children under 12 years of age • right before or after heart surgery • with any other product containing diphenhydramine, even one used on skin • if you have sleeplessness without pain

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • 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 a breathing problem such as emphysema or chronic bronchitis • you have glaucoma • you have trouble urinating due to an enlarged prostate gland

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 • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • redness or swelling is present in the painful area • any new symptoms appear • you have difficulty swallowing • it feels like the pill is stuck in your throat

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each caplet) Diphenhydramine hydrochloride 25 mg Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Naproxen Sodium Tablets 220mg - Blue (Light Blue), Oval, Imprint "L368". NDC 71335-2584-1: 20 Tablets in a BOTTLE NDC 71335-2584-2: 30 Tablets in a BOTTLE NDC 71335-2584-3: 40 Tablets in a BOTTLE NDC 71335-2584-4: 50 Tablets in a BOTTLE NDC 71335-2584-5: 60 Tablets in a BOTTLE NDC 71335-2584-6: 14 Tablets in a BOTTLE NDC 71335-2584-7: 100 Tablets in a BOTTLE NDC 71335-2584-8: 90 Tablets in a BOTTLE NDC 71335-2584-9: 24 Tablets in a BOTTLE Store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Adverse event reports

Source: openFDA FAERS
172,003
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DIPHENHYDRAMINE HYDROCHLORIDE. 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
71335-2584-1 71335-2584 Bryant Ranch Prepack 20 TABLET, FILM COATED in 1 BOTTLE (71335-2584-1) April 3, 2025
71335-2584-2 71335-2584 Bryant Ranch Prepack 30 TABLET, FILM COATED in 1 BOTTLE (71335-2584-2) April 3, 2025
71335-2584-3 71335-2584 Bryant Ranch Prepack 40 TABLET, FILM COATED in 1 BOTTLE (71335-2584-3) April 3, 2025
71335-2584-4 71335-2584 Bryant Ranch Prepack 50 TABLET, FILM COATED in 1 BOTTLE (71335-2584-4) April 3, 2025
71335-2584-5 71335-2584 Bryant Ranch Prepack 60 TABLET, FILM COATED in 1 BOTTLE (71335-2584-5) April 3, 2025
71335-2584-6 71335-2584 Bryant Ranch Prepack 14 TABLET, FILM COATED in 1 BOTTLE (71335-2584-6) April 3, 2025
71335-2584-7 71335-2584 Bryant Ranch Prepack 100 TABLET, FILM COATED in 1 BOTTLE (71335-2584-7) April 3, 2025
71335-2584-8 71335-2584 Bryant Ranch Prepack 90 TABLET, FILM COATED in 1 BOTTLE (71335-2584-8) April 3, 2025
71335-2584-9 71335-2584 Bryant Ranch Prepack 24 TABLET, FILM COATED in 1 BOTTLE (71335-2584-9) April 3, 2025
0113-0901-62 0113-0901 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-0901-62) / 24 TABLET, FILM COATED in 1 BOTTLE April 23, 2014
0113-0901-71 0113-0901 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-0901-71) / 50 TABLET, FILM COATED in 1 BOTTLE April 23, 2014
0113-0901-75 0113-0901 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-0901-75) / 90 TABLET, FILM COATED in 1 BOTTLE December 8, 2021
0113-1412-71 0113-1412 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-1412-71) / 50 TABLET, FILM COATED in 1 BOTTLE November 9, 2021
0113-4368-62 0113-4368 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-4368-62) / 24 TABLET, FILM COATED in 1 BOTTLE March 31, 2014
0113-4368-71 0113-4368 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-4368-71) / 50 TABLET, FILM COATED in 1 BOTTLE March 31, 2014
0113-4368-75 0113-4368 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-4368-75) / 90 TABLET, FILM COATED in 1 BOTTLE December 8, 2021
0113-4368-79 0113-4368 L. Perrigo Company 400 TABLET, FILM COATED in 1 BOTTLE (0113-4368-79) June 19, 2018
0113-4368-82 0113-4368 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-4368-82) / 200 TABLET, FILM COATED in 1 BOTTLE (0113-4368-00) April 2, 2026
0113-8264-06 0113-8264 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-8264-06) / 160 TABLET, FILM COATED in 1 BOTTLE (0113-8264-00) February 26, 2026
0113-8264-60 0113-8264 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-8264-60) / 20 TABLET, FILM COATED in 1 BOTTLE December 28, 2018
0113-8264-71 0113-8264 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-8264-71) / 50 TABLET, FILM COATED in 1 BOTTLE March 14, 2022
68788-8443-2 68788-8443 Preferred Pharmaceuticals Inc. 20 TABLET, FILM COATED in 1 BOTTLE (68788-8443-2) May 10, 2023
68788-8443-3 68788-8443 Preferred Pharmaceuticals Inc. 30 TABLET, FILM COATED in 1 BOTTLE (68788-8443-3) May 10, 2023
68788-8443-4 68788-8443 Preferred Pharmaceuticals Inc. 40 TABLET, FILM COATED in 1 BOTTLE (68788-8443-4) May 10, 2023
68788-8443-6 68788-8443 Preferred Pharmaceuticals Inc. 60 TABLET, FILM COATED in 1 BOTTLE (68788-8443-6) May 10, 2023
63187-794-20 63187-794 Proficient Rx LP 20 TABLET, FILM COATED in 1 BOTTLE (63187-794-20) December 1, 2016
63187-794-30 63187-794 Proficient Rx LP 30 TABLET, FILM COATED in 1 BOTTLE (63187-794-30) December 1, 2016
63187-794-60 63187-794 Proficient Rx LP 60 TABLET, FILM COATED in 1 BOTTLE (63187-794-60) December 1, 2016
71335-2584 71335-2584 Bryant Ranch Prepack — March 31, 2014
0113-0901 0113-0901 L. Perrigo Company — April 23, 2014
0113-1412 0113-1412 L. Perrigo Company — November 9, 2021
0113-4368 0113-4368 L. Perrigo Company — March 31, 2014
0113-8264 0113-8264 L. Perrigo Company — December 28, 2018
68788-8443 68788-8443 Preferred Pharmaceuticals Inc. — May 10, 2023
63187-794 63187-794 Proficient Rx LP — March 31, 2014

Sources for this page

Every dataset that contributed a fact to 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 · 10 sections on this page.