Ibuprofen PM

Product NDC: 41250-285
Requested package NDC: 41250-285-22
11-digit product format: 412500285
Labeler code: 41250
Product ID: 41250-285_4faedd95-af8f-05da-e063-6394a90aec79
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN, DIPHENHYDRAMINE HCL
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: MEIJER DISTRIBUTION INC.
Application: ANDA090397
Marketing category: ANDA
Marketing start: 2021-02-24
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Active strength: 25; 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 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
A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2010-11-22

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	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pain relief pm	IBUPROFEN AND DIPHENHYDRAMINE HCL	Bionpharma Inc.	51037299-37dd-ca57-e063-6394a90a12c7	2026-05-04	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
Ibuprofen PM	IBUPROFEN, DIPHENHYDRAMINE HCL	MEIJER DISTRIBUTION INC.	bb7701aa-f482-69e7-e053-2995a90a71b8	2026-04-17	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397 ndc (package): 41250-285-22 ndc (product): 41250-285 ndc11 (package): 41250028522
Ibuprofen PM	IBUPROFEN AND DIPHENHYDRAMINE HCL	Whole Foods Market, INC.	4db58605-9cc7-e57e-e063-6294a90ab800	2026-03-23	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
Ibuprofen PM	IBUPROFEN, DIPHENHYDRAMINE HCL	HEB	3fb6c1e5-f877-2cd0-e063-6294a90ae654	2026-03-11	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
IBUPROFEN, DIPHENHYDRAMINE HCL	IBUPROFEN, DIPHENHYDRAMINE HCL	TARGET Corporation	97e2c008-1711-dcba-e053-2995a90aa2ff	2025-12-16	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
Ibuprofen PM	IBUPROFEN, DIPHENHYDRAMINE HCL	KROGER COMPANY	ca5418f2-4dc0-ad31-e053-2995a90ac1d3	2025-12-16	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
Ibuprofen PM	IBUPROFEN, DIPHENHYDRAMINE HCL	WALGREEN COMPANY	3a193fdb-ab6e-464e-9f13-fda0fa8d50a8	2023-12-27	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
Ibuprofen and Diphenhydramine HCl	IBUPROFEN, DIPHENHYDRAMINE HCL	VALU MERCHANDISERS COMPANY	fed2f7ae-2827-f967-e053-6294a90adc0a	2023-10-03	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
Ibuprofen PM	IBUPROFEN, DIPHENHYDRAMINE HCL	TOP CARE (Topco Associates LLC)	c62c6319-65eb-37e8-e053-2a95a90a9f90	2022-12-28	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
Ibuprofen PM	IBUPROFEN, DIPHENHYDRAMINE HCL	Wal-Mart Stores, Inc.	ba31970a-b952-467c-b3f8-44f7a513de34	2022-12-28	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
Ibuprofen PM	IBUPROFEN, DIPHENHYDRAMINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC.	c483bbd6-934b-660a-e053-2995a90a51b3	2022-12-27	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
Ibuprofen PM	IBUPROFEN, DIPHENHYDRAMINE HCL	CVS Pharmacy	ce4378c0-848e-7878-e053-2a95a90af0f3	2022-12-27	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
pain relief pm	IBUPROFEN, DIPHENHYDRAMINE HCL	Bionpharma Inc.	58666a5c-fc92-4c8d-9c04-f0c98dc05c56	2022-12-20	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
IBUPROFEN, DIPHENHYDRAMINE HCL	IBUPROFEN, DIPHENHYDRAMINE HCL	Rite Aid Corporation	a35f68f3-c7f8-a55f-e053-2a95a90a9047	2020-04-15	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
IBUPROFEN, DIPHENHYDRAMINE HCL	IBUPROFEN, DIPHENHYDRAMINE HCL	Bionpharma Inc.	59a97c31-db90-48e1-ac1b-0f7026c8ec94	2018-11-09	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397
Ibuprofen PM	IBUPROFEN, DIPHENHYDRAMINE HCL	Premier Value Alliance LLC	21afce91-afbe-4b38-a8a5-8775148835e8	2018-10-30	Warnings	Exact identifier application applno (ANDA): 090397 application number: ANDA090397

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	25 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
901814	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
bb7701aa-f482-69e7-e053-2995a90a71b8	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
41250-285-15	Ibuprofen PM	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	4
41250-285-15	Ibuprofen PM	40 in 1 BOTTLE	CAPSULE, LIQUID FILLED	40	4
41250-285-22	Ibuprofen PM	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-285	IBUPROFEN PM (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [MEIJER DISTRIBUTION INC.]	3	Current NDC, Legacy NDC, 3 package rows	20221020_bb7701aa-f482-69e7-e053-2995a90a71b8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
901814	ibuprofen 200 MG / diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	bb7701aa-f482-69e7-e053-2995a90a71b8	4
901814	diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral Capsule	SCD	bb7701aa-f482-69e7-e053-2995a90a71b8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-285-22	41250028522	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (41250-285-22)	2021-02-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Ibu Diphen Caps	MEIJER DISTRIBUTION INC. \| Bionpharma Inc. \| Patheon Softgels Inc.	2026-04-17	HUMAN OTC DRUG LABEL	4