On this page
Ibuprofen and Diphenhydramine Citrate
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 |
|---|---|---|
| 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| 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| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | May 31, 2022 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Purpose
openFDA Drug LabelingPurposes Nighttime sleep-aid Pain reliever
Dosage and Administration
openFDA Drug LabelingDirections 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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
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 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 LabelingDrug 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 FAERSAttributed 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| 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
| 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.