Ibuprofen

Product NDC: 63868-709
11-digit product format: 638680709
Labeler code: 63868
Product ID: 63868-709_560679f3-86ef-4332-90a3-b2d92667ac53
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: ANDA074916
Marketing category: ANDA
Marketing start: 2020-03-02
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63868-709		D	Discontinued by firm		2026-08-03
excluded package	package	63868-709	63868-709-04	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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-709-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-709-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63868-709-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63868-709-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63868-709-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63868-709-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63868-709-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63868-709-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63868-709-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63868-709-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63868-709-04	`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
A074916-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1999-04-30

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	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-709-04	2023-10-17	C162847	48780-1	f386c649-af9d-0266-e053-dadaa90a7c1a	Ibuprofen Oral Suspension, USP
63868-709-04	2023-01-30	C162847	48780-1	f386c649-af9d-0266-e053-dadaa90a7c1a	Ibuprofen Oral Suspension, USP

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen Childrens	IBUPROFEN	FSA Store Inc. (Caring Mills)	e304f791-755d-4d11-a9f6-3d46ec84197f	2026-05-06	Warnings	Exact identifier application applno (ANDA): 074916 application number: ANDA074916
Childrens Ibuprofen Oral Suspension	IBUPROFEN	Pharmaceutical Associates, Inc.	7a6832f2-2d80-483c-bde3-e6cacb7c318a	2022-08-31	Warnings	Exact identifier application applno (ANDA): 074916 application number: ANDA074916
Ibuprofen Childrens	IBUPROFEN	FSA Store Inc. (Caring Mills)	6505b0f6-1045-46c5-9ece-4bb38bdb0855	2022-04-22	Warnings	Exact identifier application applno (ANDA): 074916 application number: ANDA074916

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-709-04	63868070904	1 BOTTLE in 1 CARTON (63868-709-04) > 118 mL in 1 BOTTLE	1 bottle	2020-03-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Oral Suspension, USP	QUALITY CHOICE (Chain Drug Marketing Association)	2024-10-31	HUMAN OTC DRUG LABEL	19