rx act ibuprofen pm

Product NDC: 37808-050
11-digit product format: 378080050
Labeler code: 37808
Product ID: 37808-050_51d69fcf-3d70-485c-ab77-a10bf2e0af78
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine citrate, ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: H E B
Application: ANDA079113
Marketing category: ANDA
Marketing start: 2009-03-11
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength: 38 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	37808-050		D	Discontinued by firm	2026-10-05
excluded package	package	37808-050	37808-050-27	D	Discontinued by firm	2026-10-05
excluded package	package	37808-050	37808-050-60	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 39 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37808-050-27	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37808-050-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37808-050-27	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37808-050-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37808-050-27	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37808-050-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37808-050-27	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37808-050-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37808-050-27	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37808-050-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37808-050-27	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37808-050-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37808-050-27	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37808-050-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37808-050-27	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37808-050-60	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37808-050-27	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37808-050-60	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37808-050-27	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37808-050-60	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37808-050-27	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37808-050-60	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37808-050-27	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37808-050-60	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	37808-050-60	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	37808-050-27	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET / ORAL			2008-12-22

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE CITRATE	ACTIVE INGREDIENT	4OD433S209	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RX ACT IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [H E B]	2

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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Publix Super Markets Inc	0240bec9-9477-4d58-9a19-63bb5d2795e0	2023-11-13	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
foster and thrive ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Strategic Sourcing Services LLC	8691e397-e598-4e23-a389-2dbbb8f4496a	2023-11-01	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113

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