ibuprofen

Product NDC: 0904-5463
11-digit product format: 009045463
Labeler code: 0904
Product ID: 0904-5463_baccf3cf-e20d-468c-9b23-d39361a9a302
Type: HUMAN OTC DRUG
Nonproprietary name: ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA075217
Marketing category: ANDA
Marketing start: 2000-01-08
Substance: IBUPROFEN
Active strength: 50 mg/1.25mL
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-5463	0904-5463-30	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A075217-001	IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL			1998-12-16

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	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: ibuprofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	50 mg/1.25mL

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
204442	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
b4962985-47e6-4389-874f-76742b086e2f	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
0904-5463-30	ibuprofen	30 mL in 1 BOTTLE	SUSPENSION	30	5
0904-5463-30	ibuprofen	1 in 1 CARTON	SUSPENSION	1	5
0904-5463-35	ibuprofen	15 mL in 1 BOTTLE	SUSPENSION	15	5
0904-5463-35	ibuprofen	1 in 1 CARTON	SUSPENSION	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5463-35	ML - Milliliter	0904-5463	0f132a23-3077-4efd-be0b-c47d71e3ba6b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5463	IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 4 package rows	20250505_b4962985-47e6-4389-874f-76742b086e2f.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 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ibuprofen	IBUPROFEN	Rite Aid Corporation	99a76de3-166a-4902-b400-b262a4fa0ae8	2026-05-27	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Good Sense Infants Ibuprofen	IBUPROFEN	L. Perrigo Company	3d2fa7ad-1574-4c79-959d-3ee284468a99	2026-05-11	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
ibuprofen infants	IBUPROFEN	H E B	e353bc69-c03e-4bae-a357-f7f3fab91695	2026-05-07	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
infants dye free ibuprofen	IBUPROFEN	Kroger Company	6dc009c8-5b44-4d53-b053-eaed2223d975	2026-05-05	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Good Sense ibuprofen infants	IBUPROFEN	L. Perrigo Company	c79e65e7-149b-450f-b083-99e16ff71729	2026-04-14	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
care one ibuprofen	IBUPROFEN	American Sales Company	15f63d40-276c-4c02-9f8c-0354e4779916	2026-04-09	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
ibuprofen	IBUPROFEN	CVS Pharmacy	e28d0916-8165-431c-a19c-ef7d4bb6b8e6	2026-02-26	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
ibuprofen infants	IBUPROFEN	HyVee Inc	e8fcaf17-234a-4d64-b621-9ca505884b0a	2026-01-12	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Foster and Thrive Ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	bcfa45ac-63d6-49a7-aa1c-b9f1d6c571f3	2025-10-22	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
ibuprofen	IBUPROFEN	Meijer Distribution Inc	e28e64dc-5f4e-4260-953a-3de38a5eaa76	2025-09-15	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
INFANTS IBUPROFEN	IBUPROFEN	Safeway	6fed7c65-69a3-4899-a85d-23ea95f571a4	2025-07-21	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
profen ib infants	IBUPROFEN	Publix Super Markets Inc	84aea3fc-4f3b-4a76-a3a6-94ed6549dbea	2025-07-17	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Dg Health Ibuprofen	IBUPROFEN	Dolgencorp, LLC	9022e393-084e-499b-ac84-f35360d79592	2025-07-17	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
dg health ibuprofen	IBUPROFEN	Dolgencorp, LLC	d6dcbdee-7c0d-4b5c-b0c1-1e8f357f7f59	2025-05-15	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Equaline Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	c611afc0-5cde-4f01-908a-de52cb61ab02	2025-05-08	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
ibuprofen	IBUPROFEN	Major Pharmaceuticals	b4962985-47e6-4389-874f-76742b086e2f	2025-05-03	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217 ndc (product): 0904-5463
Topcare Infants Ibuprofen	IBUPROFEN	Topco Associates LLC	00d33273-e8c7-4d40-8e6f-a980f746fff2	2025-05-03	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
profen ib	IBUPROFEN	Publix Super Markets Inc	bee4b754-c476-4d0e-a1b4-4db8861af84a	2025-05-01	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
parents choice infants ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	a826d6cc-f582-4508-897d-0d637de0666c	2025-04-07	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
up and up dye free infants concentrated ibuprofen	IBUPROFEN	Target Corporation	6cfdcd94-95cb-4447-a14b-cdb49a1e3114	2025-04-07	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217

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
204442	ibuprofen 50 MG in 1.25 mL Oral Suspension	PSN	b4962985-47e6-4389-874f-76742b086e2f	5
204442	ibuprofen 40 MG/ML Oral Suspension	SCD	b4962985-47e6-4389-874f-76742b086e2f	5
204442	ibuprofen 50 MG per 1.25 ML Oral Suspension	SY	b4962985-47e6-4389-874f-76742b086e2f	5
204442	ibuprofen 50 MG per 1.25 ML Oral Suspension Drops	SY	b4962985-47e6-4389-874f-76742b086e2f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5463-30	00904546330	30 mL in 1 BOTTLE	30 ml					Historical
0904-5463-35	00904546335	1 BOTTLE in 1 CARTON (0904-5463-35) / 15 mL in 1 BOTTLE	1 bottle	2000-01-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals Ibuprofen Oral Suspension Drug Facts	Major Pharmaceuticals	2025-05-03	HUMAN OTC DRUG LABEL	5