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Ibuprofen and Diphenhydramine Citrate

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
Ibuprofen and Diphenhydramine Citrate
Generic name
Ibuprofen and Diphenhydramine Citrate
Dosage form
Tablet, Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
3
Packages
22
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 Citrate 38 mg/1 895664 View
Ibuprofen 200 mg/1 310965 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
25

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
216204
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 31, 2022
Sponsor
AUROBINDO PHARMA
Products on application
1
Submissions recorded
1
Products approved under application 216204.
Product Trade name Form Strength Ingredient Status TE Flags
216204-001 IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET DIPHENHYDRAMINE CITRATE; IBUPROFEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 216204.
Type No. Action Status Date Review
Original application 1 Approved May 31, 2022 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20220603). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20220603

Indications and Usage

openFDA Drug Labeling

Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

Purposes Nighttime sleep-aid Pain reliever

Dosage and Administration

openFDA Drug Labeling

Directions do not take more than directed adults and children 12 years and over: take 2 capsules at bedtime do not take more than 2 capsules in 24 hours Other information read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F)

Warnings Allergy alert: Ibuprofen 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

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

Active Ingredient

openFDA Drug Labeling

Drug Facts Active ingredients (in each caplet) Diphenhydramine citrate USP 38 mg Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Adverse event reports

Source: openFDA FAERS
283,546
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: IBUPROFEN. 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
59651-692-62 59651-692 Aurobindo Pharma Limited 30000 TABLET, COATED in 1 BAG (59651-692-62) May 31, 2022
58602-867-09 58602-867 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-867-09) / 30 TABLET, COATED in 1 BOTTLE May 31, 2022
58602-867-12 58602-867 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-867-12) / 40 TABLET, COATED in 1 BOTTLE May 31, 2022
58602-867-14 58602-867 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-867-14) / 50 TABLET, COATED in 1 BOTTLE May 31, 2022
58602-867-18 58602-867 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-867-18) / 80 TABLET, COATED in 1 BOTTLE May 31, 2022
58602-867-21 58602-867 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-867-21) / 100 TABLET, COATED in 1 BOTTLE May 31, 2022
58602-867-23 58602-867 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-867-23) / 120 TABLET, COATED in 1 BOTTLE May 31, 2022
58602-867-27 58602-867 Aurohealth LLC 140 TABLET, COATED in 1 BOTTLE (58602-867-27) May 31, 2022
58602-867-32 58602-867 Aurohealth LLC 180 TABLET, COATED in 1 BOTTLE (58602-867-32) May 31, 2022
58602-867-34 58602-867 Aurohealth LLC 200 TABLET, COATED in 1 BOTTLE (58602-867-34) May 31, 2022
58602-867-46 58602-867 Aurohealth LLC 140 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-46) May 31, 2022
58602-867-70 58602-867 Aurohealth LLC 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-70) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC May 31, 2022
58602-867-72 58602-867 Aurohealth LLC 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-72) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC May 31, 2022
58602-867-73 58602-867 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-867-73) / 20 TABLET, COATED in 1 BOTTLE May 31, 2022
58602-867-78 58602-867 Aurohealth LLC 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-78) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC May 31, 2022
58602-867-80 58602-867 Aurohealth LLC 200 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-80) May 31, 2022
58602-867-92 58602-867 Aurohealth LLC 180 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-92) May 31, 2022
58602-867-97 58602-867 Aurohealth LLC 120 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-97) May 31, 2022
21130-228-12 21130-228 Better Living Brands, LLC 1 BOTTLE in 1 CARTON (21130-228-12) / 40 TABLET, COATED in 1 BOTTLE November 15, 2023
21130-228-18 21130-228 Better Living Brands, LLC 1 BOTTLE in 1 CARTON (21130-228-18) / 80 TABLET, COATED in 1 BOTTLE November 15, 2023
21130-228-23 21130-228 Better Living Brands, LLC 1 BOTTLE in 1 CARTON (21130-228-23) / 120 TABLET, COATED in 1 BOTTLE November 15, 2023
21130-228-73 21130-228 Better Living Brands, LLC 1 BOTTLE in 1 CARTON (21130-228-73) / 20 TABLET, COATED in 1 BOTTLE November 15, 2023
59651-692 59651-692 Aurobindo Pharma Limited — May 31, 2022
58602-867 58602-867 Aurohealth LLC — May 31, 2022
21130-228 21130-228 Better Living Brands, LLC — November 15, 2023

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.