pain relief pm

Product NDC: 69452-264
Requested package NDC: 69452-264-22
11-digit product format: 694520264
Labeler code: 69452
Product ID: 69452-264_f0471f5f-e8eb-fe08-e053-2995a90a50f6
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN, DIPHENHYDRAMINE HCL
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA090397
Marketing category: ANDA
Marketing start: 2019-05-01
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: 2026-12-31
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: pain relief pm
Listing expiration: 2026-12-31

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
58666a5c-fc92-4c8d-9c04-f0c98dc05c56	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	Strength	SPL version
69452-264-22	pain relief pm	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-264	PAIN RELIEF PM (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [BIONPHARMA INC.]	2	Current NDC, Legacy NDC, 1 package rows	20221221_58666a5c-fc92-4c8d-9c04-f0c98dc05c56.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 · 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
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 ndc (package): 69452-264-22 ndc (product): 69452-264 ndc11 (package): 69452026422
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

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	58666a5c-fc92-4c8d-9c04-f0c98dc05c56	2
901814	diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral Capsule	SCD	58666a5c-fc92-4c8d-9c04-f0c98dc05c56	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-264-22	69452026422	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-264-22)	2019-05-01	0000-00-00	No	No	Current