Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg

Product NDC: 63548-0197
11-digit product format: 635480197
Labeler code: 63548
Product ID: 63548-0197_fbc47d79-348d-436e-ae3f-364d76f58e49
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen, Diphenhydramine Citrate
Dosage form: TABLET
Route: ORAL
Labeler: PLD Acquisitions LLC DBA Av�ma Pharma Solutions
Application: ANDA211404
Marketing category: ANDA
Marketing start: 2024-04-11
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: 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
A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET / ORAL			2024-04-11

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.

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	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211404-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2024-04-11	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	38 mg/1
DIPHENHYDRAMINE CITRATE	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
4OD433S209	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
a7d729bf-6d7a-415a-a414-cae0ba6d0063	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
63548-0197-2	Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg	1 in 1 BOX	TABLET	1	6
63548-0197-2	Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg	20 in 1 BOTTLE, PLASTIC	TABLET	20	6
63548-0197-3	Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg	300 in 1 BOTTLE, PLASTIC	TABLET	300	6
63548-0197-8	Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg	8 in 1 BOTTLE, PLASTIC	TABLET	8	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63548-0197	IBUPROFEN 200 MG AND DIPHENHYDRAMINE CITRATE 38 MG (IBUPROFEN, DIPHENHYDRAMINE CITRATE) TABLET [PLD ACQUISITIONS LLC DBA AV&EACUTE;MA PHARMA SOLUTIONS]	6	Current NDC, 4 package rows	20240426_a7d729bf-6d7a-415a-a414-cae0ba6d0063.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
Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Safeway, Inc.	e49d1e9e-99a6-4d81-90d6-ef23a584a3d1	2026-01-05	Warnings	Exact identifier application applno (ANDA): 211404 application number: ANDA211404
Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Family Dollar (FAMILY WELLNESS)	e01be0d7-e16d-44f1-9a0c-251ff9a65d28	2025-10-22	Warnings	Exact identifier application applno (ANDA): 211404 application number: ANDA211404
Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	WR Group, Inc.	1e2feaf0-7fff-43d5-bcfe-9f2851bdc805	2025-03-25	Warnings	Exact identifier application applno (ANDA): 211404 application number: ANDA211404
Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg	IBUPROFEN, DIPHENHYDRAMINE CITRATE	PLD Acquisitions LLC DBA Avma Pharma Solutions	a7d729bf-6d7a-415a-a414-cae0ba6d0063	2024-04-24	Warnings	Exact identifier application applno (ANDA): 211404 application number: ANDA211404 ndc (product): 63548-0197
Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	WALMART INC. (see also Equate)	d86151b6-d5c5-4d93-9cfd-43ab7ad0443a	2024-04-15	Warnings	Exact identifier application applno (ANDA): 211404 application number: ANDA211404

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	a7d729bf-6d7a-415a-a414-cae0ba6d0063	6
895664	diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet	SCD	a7d729bf-6d7a-415a-a414-cae0ba6d0063	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63548-0197-2	63548019702	1 BOTTLE, PLASTIC in 1 BOX (63548-0197-2) / 20 TABLET in 1 BOTTLE, PLASTIC		2024-04-11	No	No	Current
63548-0197-3	63548019703	300 TABLET in 1 BOTTLE, PLASTIC (63548-0197-3)	300 tablet	2024-04-11	No	No	Current
63548-0197-8	63548019708	8 TABLET in 1 BOTTLE, PLASTIC (63548-0197-8)	8 tablet	2024-04-11	No	No	Current