ADVIL PM

Product NDC: 85237-1784
11-digit product format: 852371784
Labeler code: 85237
Product ID: 85237-1784_52c6675a-0f8f-f7bf-e063-6394a90acddc
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine citrate and ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Select Consumer Group
Application: NDA021394
Marketing category: NDA
Marketing start: 2005-12-21
Substance: DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength: 38; 200 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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 Orange Book product history#

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: ADVIL PM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE CITRATE	38 mg/1
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4OD433S209	Internal UNII lookup
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
895664	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
52c67ae0-707c-851b-e063-6294a90afda4	Available on FDA.report

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 021394 application number: NDA021394 ndc (product): 85237-1784
Advil PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Navajo Manufacturing Company Inc.	a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7	2026-04-08	Warnings	Exact identifier application applno (NDA): 021394 application number: NDA021394
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated	ADVIL PM	Lil Drug Store Products, Inc	d1138e15-8ae4-7b49-e053-2995a90a9607	2024-12-30	Warnings	Exact identifier application applno (NDA): 021394 application number: NDA021394
Advil PM, TRAVEL BASIX	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	Lil' Drug Store Products, Inc.	b876bb40-a38b-445a-bc8a-466b3bfe166d	2024-11-27	Warnings	Exact identifier application applno (NDA): 021394 application number: NDA021394
ADVIL PM	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	Haleon US Holdings LLC	658fc201-47c9-6a6d-8af9-6208298d43b4	2024-04-08	Warnings	Exact identifier application applno (NDA): 021394 application number: NDA021394

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4OD433S209	DIPHENHYDRAMINE CITRATE	88637-37-0	DIPHENHYDRAMINE CITRATE
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85237-1784-1	85237178401	1 POUCH in 1 CONTAINER (85237-1784-1) / 2 TABLET, COATED in 1 POUCH (85237-1784-0)	1 pouch	2025-06-04	No	No	Current
85237-1784-2	85237178402	2 POUCH in 1 CONTAINER (85237-1784-2) / 2 TABLET, COATED in 1 POUCH (85237-1784-0)	2 pouch	2025-06-04	No	No	Current
85237-1784-4	85237178404	25 POUCH in 1 CARTON (85237-1784-4) / 2 TABLET, COATED in 1 POUCH (85237-1784-0)	25 pouch	2025-06-04	No	No	Current
85237-1784-5	85237178405	30 POUCH in 1 CARTON (85237-1784-5) / 2 TABLET, COATED in 1 POUCH (85237-1784-0)	30 pouch	2025-06-04	No	No	Current
85237-1784-7	85237178407	3 POUCH in 1 CONTAINER (85237-1784-7) / 2 TABLET, COATED in 1 POUCH (85237-1784-0)	3 pouch	2025-06-04	No	No	Current