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Naproxen Sodium and Diphenhydramine HCl

Naproxen Sodium and Diphenhydramine · 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
Naproxen Sodium and Diphenhydramine HCl
Generic name
Naproxen Sodium and Diphenhydramine
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Amneal Pharmaceuticals NY LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
8
Data completeness
76% 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
10

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
209726
Application type
ANDA · Abbreviated New Drug Application
Approval date
October 23, 2018
Sponsor
AMNEAL PHARMS CO
Products on application
1
Submissions recorded
1
Products approved under application 209726.
Product Trade name Form Strength Ingredient Status TE Flags
209726-001 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM Discontinued —

Approval history

Source: Drugs@FDA
Most recent submissions on application 209726.
Type No. Action Status Date Review
Original application 1 Approved October 23, 2018 Standard

Review documents

  • 0 · Original application · November 15, 2018

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250801). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250801 HUMAN OTC DRUG · 20231230

Indications and Usage

openFDA Drug Labeling

USE(S) for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

Purposes Night time sleep-aid Pain reliever

Dosage and Administration

openFDA Drug Labeling

DIRECTIONS • do not take more than directed • drink a full glass of water with each dose • adults and children 12 years and over: take 2 caplets at bedtime • do not take more than 2 caplets in 24 hours • if taken with food, this product may take longer to work

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 non-prescription 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.

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, Drug Facts Drug Facts 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 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 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 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

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

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
69238-1422-2 69238-1422 Amneal Pharmaceuticals NY LLC 1 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLE October 23, 2018
69238-1422-4 69238-1422 Amneal Pharmaceuticals NY LLC 1 BOTTLE in 1 CARTON (69238-1422-4) / 40 TABLET, FILM COATED in 1 BOTTLE October 23, 2018
69238-1422-6 69238-1422 Amneal Pharmaceuticals NY LLC 1 BOTTLE in 1 CARTON (69238-1422-6) / 160 TABLET, FILM COATED in 1 BOTTLE October 23, 2018
69238-1422-8 69238-1422 Amneal Pharmaceuticals NY LLC 1 BOTTLE in 1 CARTON (69238-1422-8) / 80 TABLET, FILM COATED in 1 BOTTLE October 23, 2018
62207-814-38 62207-814 Granules India Ltd 37500 TABLET, FILM COATED in 1 POUCH (62207-814-38) February 20, 2021
62207-814-39 62207-814 Granules India Ltd 7500 TABLET, FILM COATED in 1 POUCH (62207-814-39) February 20, 2021
62207-814-47 62207-814 Granules India Ltd 500 TABLET, FILM COATED in 1 BOTTLE (62207-814-47) February 20, 2021
62207-814-95 62207-814 Granules India Ltd 1 BOTTLE in 1 CARTON (62207-814-95) / 20 TABLET, FILM COATED in 1 BOTTLE February 20, 2021
69238-1422 69238-1422 Amneal Pharmaceuticals NY LLC — October 23, 2018
62207-814 62207-814 Granules India Ltd — February 20, 2021

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.