Childrens Ibuprofen

Product NDC: 76413-344
11-digit product format: 764130344
Labeler code: 76413
Product ID: 76413-344_d4a5a980-a780-4bb6-a926-8d6648397db0
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Central Texas Community Health Centers
Application: ANDA074916
Marketing category: ANDA
Marketing start: 2006-06-01
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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	76413-344		I	Inactivated by FDA		2026-08-17
excluded package	package	76413-344	76413-344-01	I	Inactivated by FDA		2026-08-17

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 · 42 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	76413-344-01	`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	76413-344-01	`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	76413-344-01	`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	76413-344-01	`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	76413-344-01	`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	76413-344-01	`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	76413-344-01	`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	76413-344-01	`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	76413-344-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76413-344-01	`ad56d346431e…`	`cc804d4bbf1e…`
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	76413-344-01	`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	76413-344-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76413-344-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76413-344-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76413-344-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76413-344-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76413-344-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76413-344-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76413-344-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76413-344-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	76413-344-01	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`caaa826d4ba7…`
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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76413-344-01	2020-01-31	C162847	48780-1	9d75b9d0-e437-f424-e053-dadaa90a57ce	Children's Ibuprofen Oral Suspension, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76413-344-01	Childrens Ibuprofen	118 mL in 1 BOTTLE	SUSPENSION	118		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76413-344	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]	1	Legacy NDC, 1 package rows	20170909_3987b4e9-a7ac-420a-b040-91562972c9ee.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	3987b4e9-a7ac-420a-b040-91562972c9ee	1
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	3987b4e9-a7ac-420a-b040-91562972c9ee	1
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	3987b4e9-a7ac-420a-b040-91562972c9ee	1
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	3987b4e9-a7ac-420a-b040-91562972c9ee	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
76413-344-01	76413034401	118 mL in 1 BOTTLE	118 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Ibuprofen Oral Suspension, USP	Central Texas Community Health Centers	2017-09-08	HUMAN OTC DRUG LABEL	1