ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated

Product NDC: 29485-7088
Requested package NDC: 29485-7088-4
11-digit product format: 294857088
Labeler code: 29485
Product ID: 29485-7088_e41b69e1-b680-565d-e053-2a95a90aeee0
Type: HUMAN OTC DRUG
Nonproprietary name: Advil PM
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Mechanical Servants LLC
Application: NDA021394
Marketing category: NDA
Marketing start: 2011-08-31
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength: 38 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	29485-7088	29485-7088-4	D	Discontinued by firm		2026-10-05

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.

DailyMed Product Concepts#

Product concept, Relation, Version table
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29485-7088-4	ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated	2 in 1 POUCH	TABLET, COATED	2		5
29485-7088-4	ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated	2 in 1 BLISTER PACK	TABLET, COATED	2		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29485-7088	ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED (ADVIL PM) TABLET, COATED [LIL DRUG STORE PRODUCTS, INC]	5	Legacy NDC, 2 package rows	20250101_d1138e15-8ae4-7b49-e053-2995a90a9607.zip

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
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 ndc (package): 29485-7088-4 ndc (product): 29485-7088 ndc11 (package): 29485708804
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
895664	ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral Tablet	PSN	d1138e15-8ae4-7b49-e053-2995a90a9607	5
895664	diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet	SCD	d1138e15-8ae4-7b49-e053-2995a90a9607	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29485-7088-4	29485708804	2 POUCH in 1 BLISTER PACK (29485-7088-4) > 2 TABLET, COATED in 1 POUCH	2 pouch	2011-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated	Lil Drug Store Products, Inc	2024-12-30	HUMAN OTC DRUG LABEL	5