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 caplets at bedtime do not take more than 2 caplets in 24 hours
Diphenhydramine citrate 38 mg
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Nighttime sleep-aid
Pain reliever
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.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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 right away.
calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL
Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.
For most recent product information, visit
www.Advil.com.
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
©2021 GSK or licensor Trademarks owned or licensed by GSK
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0655708017807 | GTIN-13: 0655708017807 EAN-13: 0655708017807 GTIN-12: 655708017807 UPC-A: 655708017807 GTIN storage (14 digits): 00655708017807 | 2501780055 - Advil PM - 1784-4.jpg |
| Barcode | EAN-13 | 0655708017845 | GTIN-13: 0655708017845 EAN-13: 0655708017845 GTIN-12: 655708017845 UPC-A: 655708017845 GTIN storage (14 digits): 00655708017845 | 2501784059 - Advil PM - 1784-5.jpg |
| Barcode | EAN-13 | 0655708117842 | GTIN-13: 0655708117842 EAN-13: 0655708117842 GTIN-12: 655708117842 UPC-A: 655708117842 GTIN storage (14 digits): 00655708117842 | 2511784055 - Advil PM - 1784-1.jpg |
| Barcode | EAN-13 | 0655708217849 | GTIN-13: 0655708217849 EAN-13: 0655708217849 GTIN-12: 655708217849 UPC-A: 655708217849 GTIN storage (14 digits): 00655708217849 | 2521784058 - Advil PM - 1784-2.jpg |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0573-0164-05 | EA - Each | 0573-0164 | 29ee0873-ce1d-488b-945e-8060bb4ccb4a | 1 | 2012-07-24 |
| 0573-0164-08 | EA - Each | 0573-0164 | 61da8eca-12fa-4e21-ad47-a371b3e87f99 | 1 | 2022-06-06 |
| 0573-0164-12 | EA - Each | 0573-0164 | 17b84eac-a74d-4ffe-8ac8-3de75c13d8e0 | 1 | 2019-06-19 |
| 0573-0164-14 | EA - Each | 0573-0164 | f1a6b8ef-c28d-4a6d-9a89-98d4e5372015 | 1 | 2019-06-19 |
| 0573-0164-20 | EA - Each | 0573-0164 | e0975540-d483-4aa3-9a5f-a647f2986fcc | 1 | 2012-07-24 |
| 0573-0164-30 | EA - Each | 0573-0164 | da7bb72a-9d06-4eb0-b919-d87393627420 | 1 | 2012-07-24 |
| 0573-0164-40 | EA - Each | 0573-0164 | ad944255-4b0d-4ec7-9f86-47f47e6b9d91 | 1 | 2012-07-24 |
| 0573-0164-43 | EA - Each | 0573-0164 | 40258c9f-9173-4c4c-95de-258d67f51a5f | 1 | 2013-08-02 |
| 0573-0164-55 | EA - Each | 0573-0164 | 88938333-f8b2-4a98-8627-645de71706b2 | 1 | 2014-02-04 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 85237-1784 | 85237-1784-0, 85237-1784-1, 85237-1784-2, 85237-1784-4, 85237-1784-5, 85237-1784-7 |
| 0573-0164 |
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 |
|---|---|---|---|---|---|---|---|
| N021394-001 | ADVIL PM | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | f41ea6bd6efb… |
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021394-001 | 8263647 | 2022-05-30 | Drug product | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021394-001 | 8263647 | 2022-05-30 | Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021394-001 | 8263647 | 2022-05-30 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021394-001 | 8263647 | 2022-05-30 | Drug product | ea99ee380514… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N021394-001 | 8263647 | 2022-05-30 | Drug product | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N021394-001 | 8263647 | 2022-05-30 | Drug product | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021394-001 | 8263647 | 2022-05-30 | Drug product | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| ADVIL PM | DIPHENHYDRAMINE CITRATE AND IBUPROFEN | Select Consumer Group | 52c67ae0-707c-851b-e063-6294a90afda4 | 2026-05-27 | Warnings | 85237-1784-1 85237-1784-7 85237-1784-4 85237-1784-0 85237-1784-2 85237-1784-5 85237-1784 85237178400 85237178402 85237178404 85237178405 85237178401 85237178407 52c6675a-0f8f-f7bf-e063-6394a90acddc 52c67ae0-707c-851b-e063-6294a90afda4 |
| ADVIL PM | DIPHENHYDRAMINE CITRATE AND IBUPROFEN | Haleon US Holdings LLC | 658fc201-47c9-6a6d-8af9-6208298d43b4 | 2024-04-08 | Warnings | 0573-0164 |
Adverse event summaries are temporarily unavailable. Other product information remains available.