Ibuprofen

Product NDC: 55910-046
11-digit product format: 559100046
Labeler code: 55910
Product ID: 55910-046_d8c61cf2-9838-4a84-9454-dc47782880f9
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application: ANDA207753
Marketing category: ANDA
Marketing start: 2020-07-30
Marketing end: 2027-02-01
Substance: IBUPROFEN
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
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
A207753-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2018-06-29

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2018-06-29	`a50c72e98297…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Aurohealth LLC	43c94480-78d1-4a23-91d4-1d49fea72cb7	2026-06-05	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	P & L Development, LLC	ce215099-91b0-43fd-8ac9-17fe6508842c	2025-11-11	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	da9d0301-ec14-40c5-b0b9-17096913a849	2025-11-11	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753 ndc (product): 55910-046
Ibuprofen	IBUPROFEN	Better Living Brands LLC	f6ef7f73-b5ab-4c82-e053-6394a90ac81e	2023-09-22	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	RITE AID CORPORATION	de158883-1175-18fc-e053-2995a90a3c96	2023-04-12	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Aurohealth LLC	e1b49257-d226-457f-8f2d-9a757a65bbcb	2022-09-06	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Aurohealth LLC	7779c369-50bf-4cde-9015-ff3fb35e128e	2022-05-16	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Aurohealth LLC	3b0e77a1-b49d-4c67-81dd-66450dabcf3b	2022-03-04	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
310964	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
da9d0301-ec14-40c5-b0b9-17096913a849	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
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
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	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
55910-046-02	Ibuprofen	200 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	200	3
55910-046-12	Ibuprofen	120 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	120	3
55910-046-20	Ibuprofen	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	3
55910-046-20	Ibuprofen	20 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	20	3
55910-046-40	Ibuprofen	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	3
55910-046-40	Ibuprofen	40 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	40	3
55910-046-80	Ibuprofen	80 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	80	3
55910-046-80	Ibuprofen	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-046	IBUPROFEN CAPSULE, LIQUID FILLED [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]	2	Current NDC, Legacy NDC, 8 package rows	20221203_da9d0301-ec14-40c5-b0b9-17096913a849.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310964	ibuprofen 200 MG Oral Capsule	PSN	da9d0301-ec14-40c5-b0b9-17096913a849	3
310964	ibuprofen 200 MG Oral Capsule	SCD	da9d0301-ec14-40c5-b0b9-17096913a849	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-046-02	55910004602	200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (55910-046-02)	2020-07-30	2027-02-01	No	No	Current
55910-046-12	55910004612	120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (55910-046-12)	2020-07-30	2027-02-01	No	No	Current
55910-046-20	55910004620	1 BOTTLE, PLASTIC in 1 BOX (55910-046-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC	2020-07-30	2027-02-01	No	No	Current
55910-046-40	55910004640	1 BOTTLE, PLASTIC in 1 BOX (55910-046-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC	2020-07-30	2027-02-01	No	No	Current
55910-046-80	55910004680	1 BOTTLE, PLASTIC in 1 BOX (55910-046-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC	2020-07-30	2027-02-01	No	No	Current