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
Diphenhydramine hydrochloride 25 mg
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*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.
D&C red no. 33, FD&C blue no. 1, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution
Call 1-855-297-3031
Do Not Use if seal under bottle cap imprinted with
“SEALED for YOUR PROTECTION” is broken or missing.
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
| 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 | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0573-0167-10 | EA - Each | 0573-0167 | 215fd11c-a5f8-40b6-8e00-0762da413c3c | 1 | 2014-01-04 |
| 0573-0167-20 | EA - Each | 0573-0167 | 02755d54-e1de-4282-b019-343a7ef4ea12 | 1 | 2012-07-24 |
| 0573-0167-25 | EA - Each | 0573-0167 | 5c48509c-cd84-4810-846a-2222b5543266 | 1 | 2015-04-03 |
| 0573-0167-43 | EA - Each | 0573-0167 | 08c315ed-78d2-495c-9542-7e0676410f6a | 1 | 2015-01-05 |
| 0573-0167-55 | EA - Each | 0573-0167 | 902635c1-b011-4bd5-a3c3-c40426075af0 | 1 | 2015-04-03 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 10 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 10 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 10 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 10 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 10 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 10 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 10 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 10 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 10 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | 10 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | 10 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 10 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 10 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0573-0167 | 0573-0167-10, 0573-0167-20, 0573-0167-21, 0573-0167-25, 0573-0167-43, 0573-0167-55, 0573-0167-18, 0573-0167-19, 0573-0167-26, 0573-0167-42, 0573-0167-44, 0573-0167-56 |
| 0573-0148 | 0573-0148-06, 0573-0148-07 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 21 | 2025-01-15 | full-release | 2026-06-01 00:52:52 |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, EXTENDED RELEASE / ORAL | 0.37 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | CAPSULE, LIQUID FILLED / ORAL | 154 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SOLUTION / ORAL | 5566 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SUSPENSION / ORAL | 10170 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET / ORAL | 2 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SOLUTION / ORAL | 5566 mg | ||
| SORBITAN | SORBITAN | 6O92ICV9RU | CAPSULE, LIQUID FILLED / ORAL | NA | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, EXTENDED RELEASE / ORAL | 0.37 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE, LIQUID FILLED / ORAL | 0.01 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | CAPSULE / ORAL | 4771 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SOLUTION / ORAL | 5566 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE, LIQUID FILLED / ORAL | 0.01 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET / ORAL | 2 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER, FOR SUSPENSION / ORAL | 3390 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SOLUTION / ORAL | 5566 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SUSPENSION / ORAL | 10170 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET / ORAL | 2 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, EXTENDED RELEASE / ORAL | 0.37 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | CAPSULE, LIQUID FILLED / ORAL | 154 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg |
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 |
|---|---|---|---|---|---|---|---|
| N021393-001 | ADVIL PM | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / 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 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2005-12-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021393-001 | ADVIL PM | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / 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 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | ea99ee380514… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021393-001 | 8883849 | 2022-01-17 | U-1618 | 2014-12-09 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021393-001 | 9155718 | 2022-01-17 | Drug product | 2015-11-10 | 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 HCL, IBUPROFEN | Haleon US Holdings LLC | 405afdb4-c157-1d88-f232-848063ba4714 | 2026-07-29 | Warnings | 0573-0167-25 0573-0148-06 0573-0167-42 0573-0167-20 0573-0167-26 0573-0148-07 0573-0167-56 0573-0167-43 0573-0167-21 0573-0167-18 0573-0167-44 0573-0167-55 0573-0167-10 0573-0167-19 0573-0167 0573-0148 00573016710 00573016718 00573016719 00573016742 00573014806 00573016744 00573016756 00573016743 00573016721 00573014807 00573016720 00573016725 00573016755 00573016726 57c5339d-4ab8-ce7f-e063-6394a90a75a5 405afdb4-c157-1d88-f232-848063ba4714 |
Adverse event summaries are temporarily unavailable. Other product information remains available.