Indications and uses
for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
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)
Active ingredients
(in each caplet)
Diphenhydramine citrate USP 38 mg
Ibuprofen USP 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Nighttime sleep-aid
Pain reliever
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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
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.
ask a health professional before use. It is especially important not to use ibuprofen 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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other information
carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue # 2, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, palmitic acid, polydextrose, polyethylene glycol, pregelatinized starch (maize), sodium lauryl sulfate, sodium starch glycolate, stearic acid, and titanium dioxide.
Questions or comments?
Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road,
East Windsor NJ 08520
Made in India
Code No.: TS/DRUGS/16/2014
AUROHEALTH
NDC 58602-867-73
†Compare to the active
ingredients in Advil® PM
Ibuprofen and
Diphenhydramine Citrate
Tablets
200 mg/38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid
20
Coated Caplets*
*Capsule-Shaped Tablets 200
Actual size

| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58602-867-09 | Ibuprofen and Diphenhydramine Citrate | 30 in 1 BOTTLE | TABLET, COATED | 30 | 1 | |
| 58602-867-09 | Ibuprofen and Diphenhydramine Citrate | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 58602-867-12 | Ibuprofen and Diphenhydramine Citrate | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 58602-867-12 | Ibuprofen and Diphenhydramine Citrate | 40 in 1 BOTTLE | TABLET, COATED | 40 | 1 | |
| 58602-867-14 | Ibuprofen and Diphenhydramine Citrate | 50 in 1 BOTTLE | TABLET, COATED | 50 | 1 | |
| 58602-867-14 | Ibuprofen and Diphenhydramine Citrate | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 58602-867-18 | Ibuprofen and Diphenhydramine Citrate | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 58602-867-18 | Ibuprofen and Diphenhydramine Citrate | 80 in 1 BOTTLE | TABLET, COATED | 80 | 1 | |
| 58602-867-21 | Ibuprofen and Diphenhydramine Citrate | 100 in 1 BOTTLE | TABLET, COATED | 100 | 1 | |
| 58602-867-21 | Ibuprofen and Diphenhydramine Citrate | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 58602-867-23 | Ibuprofen and Diphenhydramine Citrate | 120 in 1 BOTTLE | TABLET, COATED | 120 | 1 | |
| 58602-867-23 | Ibuprofen and Diphenhydramine Citrate | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 58602-867-27 | Ibuprofen and Diphenhydramine Citrate | 140 in 1 BOTTLE | TABLET, COATED | 140 | 1 | |
| 58602-867-32 | Ibuprofen and Diphenhydramine Citrate | 180 in 1 BOTTLE | TABLET, COATED | 180 | 1 | |
| 58602-867-34 | Ibuprofen and Diphenhydramine Citrate | 200 in 1 BOTTLE | TABLET, COATED | 200 | 1 | |
| 58602-867-46 | Ibuprofen and Diphenhydramine Citrate | 140 in 1 BOTTLE, PLASTIC | TABLET, COATED | 140 | 1 | |
| 58602-867-70 | Ibuprofen and Diphenhydramine Citrate | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 58602-867-70 | Ibuprofen and Diphenhydramine Citrate | 40 in 1 BOTTLE, PLASTIC | TABLET, COATED | 40 | 1 | |
| 58602-867-72 | Ibuprofen and Diphenhydramine Citrate | 80 in 1 BOTTLE, PLASTIC | TABLET, COATED | 80 | 1 | |
| 58602-867-72 | Ibuprofen and Diphenhydramine Citrate | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 58602-867-73 | Ibuprofen and Diphenhydramine Citrate | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 58602-867-73 | Ibuprofen and Diphenhydramine Citrate | 20 in 1 BOTTLE | TABLET, COATED | 20 | 1 | |
| 58602-867-78 | Ibuprofen and Diphenhydramine Citrate | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 58602-867-78 | Ibuprofen and Diphenhydramine Citrate | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | 1 | |
| 58602-867-80 | Ibuprofen and Diphenhydramine Citrate | 200 in 1 BOTTLE, PLASTIC | TABLET, COATED | 200 | 1 | |
| 58602-867-92 | Ibuprofen and Diphenhydramine Citrate | 180 in 1 BOTTLE, PLASTIC | TABLET, COATED | 180 | 1 | |
| 58602-867-97 | Ibuprofen and Diphenhydramine Citrate | 120 in 1 BOTTLE, PLASTIC | TABLET, COATED | 120 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-867 | 58602-867-73, 58602-867-09, 58602-867-12, 58602-867-14, 58602-867-18, 58602-867-21, 58602-867-23, 58602-867-27, 58602-867-32, 58602-867-34, 58602-867-70, 58602-867-78, 58602-867-72, 58602-867-97, 58602-867-46, 58602-867-92, 58602-867-80 |
Every source-derived ingredient row is available through these pages.
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET / ORAL | 2022-05-31 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 5c6f7cd8ea54… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216204-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2022-05-31 | a50c72e98297… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ibuprofen and Diphenhydramine Citrate | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | Aurohealth LLC | 21c1f5c5-19fa-4a59-bad3-ea85fd37471b | 2022-06-03 | Warnings | 58602-867-97 58602-867-14 58602-867-73 58602-867-21 58602-867-09 58602-867-70 58602-867-80 58602-867-18 58602-867-92 58602-867-72 58602-867-34 58602-867-46 58602-867-78 58602-867-23 58602-867-12 58602-867-27 58602-867-32 58602-867 58602086780 58602086709 58602086778 58602086746 58602086772 58602086727 58602086714 58602086732 58602086721 58602086773 58602086792 58602086712 58602086797 58602086718 58602086734 58602086770 58602086723 21c1f5c5-19fa-4a59-bad3-ea85fd37471b 21c1f5c5-19fa-4a59-bad3-ea85fd37471b |
Adverse event summaries are temporarily unavailable. Other product information remains available.