Care One Ibuprofen PM

Product NDC: 41520-050
11-digit product format: 415200050
Labeler code: 41520
Product ID: 41520-050_af71245d-9e26-4aaf-b061-3b2dc519572c
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine citrate and ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Sales Company
Application: ANDA079113
Marketing category: ANDA
Marketing start: 2009-02-20
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

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 package	package	41520-050	41520-050-48	D	Discontinued by firm	2026-08-07
excluded package	package	41520-050	41520-050-76	D	Discontinued by firm	2026-08-07
excluded package	package	41520-050	41520-050-82	D	Discontinued by firm	2026-08-07

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 · 14 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	41520-050-76	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41520-050-48	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	41520-050-76	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41520-050-48	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	41520-050-48	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	41520-050-48	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	41520-050-48	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	41520-050-48	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	41520-050-48	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	41520-050-48	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	41520-050-48	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	41520-050-48	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	41520-050-48	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	41520-050-48	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Care One Ibuprofen 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
d5bf76d1-6fed-4f6b-8507-3e8973295d67	Available on FDA.report

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	SPL version
41520-050-27	Care One Ibuprofen PM	80 in 1 BOTTLE	TABLET, FILM COATED	80	11
41520-050-27	Care One Ibuprofen PM	1 in 1 CARTON	TABLET, FILM COATED	1	11
41520-050-48	Care One Ibuprofen PM	180 in 1 BOTTLE	TABLET, FILM COATED	180	11
41520-050-48	Care One Ibuprofen PM	1 in 1 CARTON	TABLET, FILM COATED	1	11
41520-050-58	Care One Ibuprofen PM	1 in 1 CARTON	TABLET, FILM COATED	1	11
41520-050-58	Care One Ibuprofen PM	40 in 1 BOTTLE	TABLET, FILM COATED	40	11
41520-050-60	Care One Ibuprofen PM	1 in 1 CARTON	TABLET, FILM COATED	1	11
41520-050-60	Care One Ibuprofen PM	20 in 1 BOTTLE	TABLET, FILM COATED	20	11
41520-050-76	Care One Ibuprofen PM	1 in 1 CARTON	TABLET, FILM COATED	1	11
41520-050-76	Care One Ibuprofen PM	120 in 1 BOTTLE	TABLET, FILM COATED	120	11
41520-050-82	Care One Ibuprofen PM	200 in 1 BOTTLE	TABLET, FILM COATED	200	11

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-050	CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, FILM COATED [AMERICAN SALES COMPANY]	10	Current NDC, Legacy NDC, 11 package rows	20250423_d5bf76d1-6fed-4f6b-8507-3e8973295d67.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good neighbor pharmacy ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Amerisource Bergen	2829ee62-7685-4dbb-9f61-4ee0fb19e4c6	2026-05-15	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Meijer Distribution Inc	47e71e23-da8a-4759-ac5a-1d48e0d9ab98	2026-04-22	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Care One Ibuprofen PM	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	American Sales Company	d5bf76d1-6fed-4f6b-8507-3e8973295d67	2026-04-01	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113 ndc (product): 41520-050
ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Rite Aid Corporation	d9eefb84-cc2e-4deb-a1c0-a7c21929f5ac	2026-03-27	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
up and up ibuprofen pm	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	Target Corporation	0c764683-f3c9-4382-96be-d34b7a582aee	2026-03-16	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	HyVee Inc	833a2bee-0e55-44f7-b80d-b336ebe52fc9	2026-01-14	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
IBUPROFEN PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Safeway	57e8f0d7-1f21-4fda-8b21-3caa54fae4e6	2026-01-02	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
ibuprofen pm	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	CVS Pharmacy	44e4e54b-cb40-4b7c-a141-181bde62a69f	2025-10-24	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Motrin PM	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	Kenvue Brands LLC	55403f19-58ae-450b-8a7b-0bc544088f20	2025-07-11	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Kroger Company	347dd263-ba0d-4a5a-8ac8-e586fcfd014e	2025-06-23	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Walgreen Company	9c5c1f48-d285-4faa-96d0-b04f435c9c5c	2025-06-23	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	H E B	2114b2a9-f9af-43b9-97ec-859a4afe7ec8	2025-04-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
good sense ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	L. Perrigo Company	0488786f-9b6b-4935-bb57-bcb2565447f8	2025-04-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Topcare Ibuprofen PM	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	Topco Associates LLC	1435e627-144e-4dc8-9ad6-58d91cbd9094	2025-04-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
equaline ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	United Natural Foods, Inc. dba UNFI	5c4ff82a-bdc4-4df5-9df7-abc6becf4f4d	2025-04-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Exchange Select Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Army & Air Force Exchange Service	56761c01-48f2-4d17-a607-6639fb3a7a98	2025-04-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
equate ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Wal-Mart Stores Inc	e36957ed-653c-465f-8150-7d6073e1376f	2025-03-16	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Leader Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Cardinal Health 110, LLC. dba Leader	b19ad305-4464-4404-a011-584fa0c08521	2024-11-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
basic care ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Amazon.com Services LLC	6bd8bad2-4370-4450-822a-9ef50949a8fc	2024-09-09	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
dg health Ibuprofen pm	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	Dolgencorp Inc	4bbe40de-0957-4705-893d-fcb4191885c9	2024-01-22	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

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	d5bf76d1-6fed-4f6b-8507-3e8973295d67	11
895664	diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet	SCD	d5bf76d1-6fed-4f6b-8507-3e8973295d67	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-050-27	41520005027	1 BOTTLE in 1 CARTON (41520-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2009-02-20	0000-00-00	No	No	Current
41520-050-48	41520005048	1 BOTTLE in 1 CARTON (41520-050-48) > 180 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2009-03-06	0000-00-00	No	No	Current
41520-050-58	41520005058	1 BOTTLE in 1 CARTON (41520-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2009-02-20	0000-00-00	No	No	Current
41520-050-60	41520005060	1 BOTTLE in 1 CARTON (41520-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2009-02-20	0000-00-00	No	No	Current
41520-050-76	41520005076	1 in 1 CARTON						Historical
41520-050-82	41520005082	200 TABLET, FILM COATED in 1 BOTTLE (41520-050-82)		2017-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Ibuprofen PM Drug Facts	American Sales Company	2026-04-01	HUMAN OTC DRUG LABEL	11