CounterAct

Product NDC: 54473-308
11-digit product format: 544730308
Labeler code: 54473
Product ID: 54473-308_f2057d6a-e22d-4d60-e053-2a95a90a3c42
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Melaleuca, Inc
Application: ANDA091239
Marketing category: ANDA
Marketing start: 2019-08-15
Marketing end: 0000-00-00
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
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	54473-308		I	Inactivated by FDA		2026-08-03
excluded package	package	54473-308	54473-308-50	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 4 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	54473-308		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-308	54473-308-50	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	54473-308		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-308	54473-308-50	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A091239-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-02-01

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 · 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	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`cb3db0bc1861…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Grocery Outlet, Inc.	44660e1d-79c2-34ce-e063-6294a90ade3f	2026-03-17	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	Kroger Company	bc173f1b-2e44-2c2e-e053-2a95a90a89c4	2025-09-24	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES,INC	f58d35f9-e44b-417b-98ce-0766b537cd2f	2025-06-12	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	WALGREENS	7653b33c-7489-10db-e053-2991aa0ab508	2025-06-06	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
AeroTab Ibuprofen	IBUPROFEN TABLET	Aero Healthcare	ddd0f7fb-ae4b-c584-e053-2a95a90a0984	2025-02-26	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
VALUMEDS IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS LLC	a6d4ceb0-2b79-496a-aa1e-27edd507ced0	2024-12-10	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	SAM'S WEST INC	16595d75-6e74-0839-e063-6394a90abc13	2024-05-28	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	WALGREENS	746f79aa-3036-1b9b-e053-2a91aa0a1db6	2024-03-18	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN CA	IBUPROFEN	TARGET CORPORATION	8e8684fa-095e-c6d6-e053-2a95a90a15b4	2024-01-03	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e86ae68-7687-79d6-e053-2995a90ac274	2024-01-03	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb613c44-e125-0f40-e053-2995a90a7ca5	2023-10-02	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb60e636-41fe-49fb-e053-2a95a90a0616	2023-09-29	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
ibuprofen	IBUPROFEN	DOLGENCORP INC	8f1358aa-495a-23da-e053-2995a90aa430	2023-01-02	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	a7aa790a-6d6c-7929-e053-2995a90a1cf8	2022-01-04	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	3c8df1e5-61bc-4e70-b6b9-8973986ad589	2021-12-21	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	a7abac4c-7695-cfe8-e053-2a95a90ac1cd	2021-10-30	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239

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
54473-308-50	2025-01-30	C162847	48780-1	2cef2736-8c26-d83d-e063-dadaa90ab31f	CounterAct IB Content of Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-308-50	CounterActIB	1 in 1 BOX	TABLET, COATED	1		2
54473-308-50	CounterActIB	50 in 1 BOTTLE	TABLET, COATED	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-308	COUNTERACT IB (IBUPROFEN) TABLET, COATED [MELALEUCA, INC]	2	Legacy NDC, 2 package rows	20230112_90305282-f301-42c4-e053-2a95a90a6336.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
1101919	Counteract IB 200 MG Oral Tablet	PSN	90305282-f301-42c4-e053-2a95a90a6336	2
310965	ibuprofen 200 MG Oral Tablet	PSN	90305282-f301-42c4-e053-2a95a90a6336	2
1101919	ibuprofen 200 MG Oral Tablet [Counteract IB]	SBD	90305282-f301-42c4-e053-2a95a90a6336	2
310965	ibuprofen 200 MG Oral Tablet	SCD	90305282-f301-42c4-e053-2a95a90a6336	2
1101919	Counteract IB 200 MG Oral Tablet	SY	90305282-f301-42c4-e053-2a95a90a6336	2
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	90305282-f301-42c4-e053-2a95a90a6336	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54473-308-50	54473030850	1 BOTTLE in 1 BOX (54473-308-50) > 50 TABLET, COATED in 1 BOTTLE	1 bottle	2019-08-15	0000-00-00	No	No	Current