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
| 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 |
|---|---|---|---|---|---|---|
| 0573-0164-04 | ADVIL PM | 4 in 1 POUCH | TABLET, COATED | 4 | 21 | |
| 0573-0164-05 | ADVIL PM | 2 in 1 BOTTLE | TABLET, COATED | 2 | 21 | |
| 0573-0164-05 | ADVIL PM | 2 in 1 CARTON | TABLET, COATED | 2 | 21 | |
| 0573-0164-08 | ADVIL PM | 8 in 1 VIAL | TABLET, COATED | 8 | 21 | |
| 0573-0164-08 | ADVIL PM | 1 in 1 PACKAGE | TABLET, COATED | 1 | 21 | |
| 0573-0164-09 | ADVIL PM | 8 in 1 VIAL | TABLET, COATED | 8 | 21 | |
| 0573-0164-12 | ADVIL PM | 2 in 1 POUCH | TABLET, COATED | 2 | 21 | |
| 0573-0164-12 | ADVIL PM | 6 in 1 CARTON | TABLET, COATED | 6 | 21 | |
| 0573-0164-14 | ADVIL PM | 2 in 1 POUCH | TABLET, COATED | 2 | 21 | |
| 0573-0164-14 | ADVIL PM | 2 in 1 CARTON | TABLET, COATED | 2 | 21 | |
| 0573-0164-20 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-20 | ADVIL PM | 20 in 1 BOTTLE | TABLET, COATED | 20 | 21 | |
| 0573-0164-21 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-21 | ADVIL PM | 30 in 1 BOTTLE | TABLET, COATED | 30 | 21 | |
| 0573-0164-30 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-30 | ADVIL PM | 40 in 1 BOTTLE | TABLET, COATED | 40 | 21 | |
| 0573-0164-32 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-32 | ADVIL PM | 50 in 1 BOTTLE | TABLET, COATED | 50 | 21 | |
| 0573-0164-33 | ADVIL PM | 50 in 1 BOTTLE | TABLET, COATED | 50 | 21 | |
| 0573-0164-33 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-40 | ADVIL PM | 80 in 1 BOTTLE | TABLET, COATED | 80 | 21 | |
| 0573-0164-40 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-41 | ADVIL PM | 100 in 1 BOTTLE | TABLET, COATED | 100 | 21 | |
| 0573-0164-41 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-43 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-43 | ADVIL PM | 120 in 1 BOTTLE | TABLET, COATED | 120 | 21 | |
| 0573-0164-44 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-44 | ADVIL PM | 140 in 1 BOTTLE | TABLET, COATED | 140 | 21 | |
| 0573-0164-45 | ADVIL PM | 180 in 1 BOTTLE | TABLET, COATED | 180 | 21 | |
| 0573-0164-45 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-46 | ADVIL PM | 180 in 1 BOTTLE | TABLET, COATED | 180 | 21 | |
| 0573-0164-46 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-49 | ADVIL PM | 1 in 1 CARTON | TABLET, COATED | 1 | 21 | |
| 0573-0164-49 | ADVIL PM | 200 in 1 BOTTLE | TABLET, COATED | 200 | 21 | |
| 0573-0164-55 | ADVIL PM | 50 in 1 TRAY | TABLET, COATED | 50 | 21 | |
| 0573-0164-55 | ADVIL PM | 2 in 1 POUCH | TABLET, COATED | 2 | 21 | |
| 0573-0164-65 | ADVIL PM | 120 in 1 BOTTLE | TABLET, COATED | 120 | 21 | |
| 0573-0164-91 | ADVIL PM | 3000 in 1 BOX | TABLET, COATED | 3000 | 21 | |
| 0573-0164-91 | ADVIL PM | 2 in 1 POUCH | TABLET, COATED | 2 | 21 |
| 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 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPHENHYDRAMINE CITRATE | ACTIVE INGREDIENT | 4OD433S209 | 9 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 9 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 9 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 9 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | 9 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 9 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 9 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 9 | |
| GLYCERYL DIBEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | 9 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 9 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 9 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 9 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 9 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 9 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 9 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 9 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0573-0164 | 0573-0164-33, 0573-0164-04, 0573-0164-20, 0573-0164-30, 0573-0164-40, 0573-0164-43, 0573-0164-45, 0573-0164-32, 0573-0164-41, 0573-0164-91, 0573-0164-05, 0573-0164-55, 0573-0164-21, 0573-0164-44, 0573-0164-14, 0573-0164-12, 0573-0164-49, 0573-0164-46, 0573-0164-65, 0573-0164-08, 0573-0164-09 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| GLYCERYL DIBEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | TABLET, COATED / ORAL | 19 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET / ORAL | 20 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, COATED / ORAL | 123 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, COATED / ORAL | 1301 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| CALCIUM STEARATE | CALCIUM STEARATE | 776XM7047L | TABLET, COATED / ORAL | 12.2 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| CALCIUM STEARATE | CALCIUM STEARATE | 776XM7047L | TABLET, COATED / ORAL | 12.2 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| CALCIUM STEARATE | CALCIUM STEARATE | 776XM7047L | TABLET, COATED / ORAL | 12.2 mg | ||
| CALCIUM STEARATE | CALCIUM STEARATE | 776XM7047L | TABLET, COATED / ORAL | 12.2 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, COATED / ORAL | 24.12 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, COATED / ORAL | 24.12 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, COATED / ORAL | 123 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, COATED / ORAL | 1301 mg | ||
| GLYCERYL DIBEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | TABLET, COATED / ORAL | 19 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| GLYCERYL DIBEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | TABLET, COATED / ORAL | 19 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| CALCIUM STEARATE | CALCIUM STEARATE | 776XM7047L | TABLET, COATED / ORAL | 12.2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, COATED / ORAL | 123 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET / ORAL | 20 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| GLYCERYL DIBEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | TABLET, COATED / ORAL | 19 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | c2088c7a36db… | |
| 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… |
| 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 | Haleon US Holdings LLC | 658fc201-47c9-6a6d-8af9-6208298d43b4 | 2024-04-08 | Warnings | 0573-0164-40 0573-0164-44 0573-0164-49 0573-0164-04 0573-0164-41 0573-0164-45 0573-0164-09 0573-0164-91 0573-0164-32 0573-0164-12 0573-0164-14 0573-0164-55 0573-0164-43 0573-0164-05 0573-0164-65 0573-0164-21 0573-0164-46 0573-0164-20 0573-0164-08 0573-0164-30 0573-0164-33 0573-0164 00573016421 00573016433 00573016430 00573016440 00573016405 00573016441 00573016409 00573016465 00573016444 00573016443 00573016408 00573016491 00573016414 00573016432 00573016446 00573016445 00573016455 00573016420 00573016404 00573016412 00573016449 15971707-84cd-4742-e063-6394a90af906 658fc201-47c9-6a6d-8af9-6208298d43b4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.