First Aid Only Ibuprofen

Product NDC: 0924-0275
11-digit product format: 009240275
Labeler code: 0924
Product ID: 0924-0275_968b92c6-8c43-d1a1-e053-2a95a90a1f1b
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Acme United Corporation
Application: ANDA075010
Marketing category: ANDA
Marketing start: 2016-02-01
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0924-0275		I	Inactivated by FDA		2026-10-12
excluded package	package	0924-0275	0924-0275-01	I	Inactivated by FDA		2026-10-12

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 · 30 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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`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	0924-0275-01	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075010-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1999-03-01

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0924-0275-01	2023-01-30	C162847	48780-1	f386c64a-0027-0266-e053-dadaa90a7c1a	First Aid Only Ibuprofen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0924-0275-01	First Aid Only Ibuprofen	20 in 1 BOX, UNIT-DOSE	TABLET, COATED	20		2
0924-0275-01	First Aid Only Ibuprofen	2 in 1 PACKET	TABLET, COATED	2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0924-0275	FIRST AID ONLY IBUPROFEN (IBUPROFEN) TABLET, COATED [ACME UNITED CORPORATION]	2	Legacy NDC, 2 package rows	20191105_6819da97-88bf-3b4e-e053-2991aa0adeaa.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 2 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c	2026-01-12	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Meijer Distribution Inc	c0c64ba5-b6b0-4221-9e44-110d92c93782	2026-01-12	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	DOLGENCORP, LLC	37ccb303-c70e-48b3-a8a3-2b0097cf8f88	2026-01-05	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	ab313564-27dc-0297-e053-2a95a90a6690	2026-01-01	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen 24/7 Life by 7-Eleven	IBUPROFEN TABLET, FILM COATED	Lil' Drug Store Products, Inc.	45b3b825-dab7-3328-e063-6294a90a7d2a	2025-12-11	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Physicians Care Ibuprofen	IBUPROFEN 200MG	Acme United Corporation	490c1109-dad7-4135-e054-00144ff8d46c	2025-10-31	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	6521bc47-4d9c-4a5b-b109-3841f3be4b6c	2025-10-07	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Green Guard Ibupro relief	IBUPROFEN	Unifirst First Aid Corporation	2923c4a3-f994-67a7-e054-00144ff8d46c	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Medique Iprin	IBUPROFEN	Unifirst First Aid Corporation	2910b50b-c8de-382b-e054-00144ff88e88	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Medique at Home Iprin	IBUPROFEN	Unifirst First Aid Corporation	b5547f33-2a81-867d-e053-2995a90aa2d0	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Direct Safety Ibuprofen	IBUPROFEN	Conney Safety Products, LLC	28d45743-d298-29db-e054-00144ff8d46c	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Unishield Ibuprofen	IBUPROFEN	Unishield	b9e2e2ba-e2ad-eace-e053-2995a90aed35	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Uline Ibuprofen	IBUPROFEN	Uline	d7342a15-9d49-74ed-e053-2a95a90a22cc	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Henry Schein Ibuprofen	IBUPROFEN	Henry Schein Inc.	267c7c8a-2f3f-1f4d-e054-00144ff8d46c	2025-09-08	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen Thompson	IBUPROFEN	Thompson Safety	ccfbc048-f666-3188-e053-2995a90ae08f	2025-09-08	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Sam's West Inc	6293a134-860d-4d12-9e4b-28490f824108	2025-09-03	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Chain Drug Consortium	6c593a9c-680e-4645-8e8f-d8d044c92ca1	2025-07-18	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Wildman Business Group	9e71f1c1-5272-4209-8974-6c525b141155	2024-08-19	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	3e3848f2-4922-39ea-e054-00144ff88e88	2024-06-25	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
IBUPROFEN	IBUPROFEN 200MG	Lil' Drug Store Products, Inc.	8fc65767-1783-4f7f-8680-9e43ba4d5481	2024-06-19	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010

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
310965	ibuprofen 200 MG Oral Tablet	PSN	6819da97-88bf-3b4e-e053-2991aa0adeaa	2
310965	ibuprofen 200 MG Oral Tablet	SCD	6819da97-88bf-3b4e-e053-2991aa0adeaa	2
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	6819da97-88bf-3b4e-e053-2991aa0adeaa	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0924-0275-01	00924027501	20 PACKET in 1 BOX, UNIT-DOSE (0924-0275-01) > 2 TABLET, COATED in 1 PACKET	20 packet	2017-01-26	0000-00-00	No	No	Current