CounterAct

Product NDC: 54473-305
11-digit product format: 544730305
Labeler code: 54473
Product ID: 54473-305_30ce656f-cab7-9520-e063-6294a90a43ff
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Melaleuca, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-05-02
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-305-50	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-305-50	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-305-50	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-305-50	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-305-50	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-305-50	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-305-50	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: CounterAct
Brand name suffix: Pain
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198440	Internal RxNorm lookup
1100005	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
7faf76b4-7f25-377d-e053-2a91aa0a19d4	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-305-50	2025-03-21	C162847	48780-1	2cef2736-aae7-d83d-e063-dadaa90ab31f	CounterAct Pain Content of Labeling
54473-305-50	2025-01-30	C162847	48780-1	2cef2736-aae7-d83d-e063-dadaa90ab31f	CounterAct Pain Content of Labeling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-305-50	CounterActPain	50 in 1 BOTTLE	TABLET, FILM COATED	50		3
54473-305-50	CounterActPain	1 in 1 BOX	TABLET, FILM COATED	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-305	COUNTERACT PAIN (ACETAMINOPHEN) TABLET, FILM COATED [MELALEUCA, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20250323_7faf76b4-7f25-377d-e053-2a91aa0a19d4.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 29 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	355a094c-bed9-4959-8cf0-619f0e246105	2025-12-11	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	fac4e0c6-684f-45a1-99f2-de4de4017cc8	2025-12-11	Warnings	Exact identifier application number: M013
Pain Reliever PM extra strength	ACETAMINOPHEN DIPHENHYDRAMINE HCL	P & L Development, LLC	90eba2e8-52c3-43f5-ba93-4a520368c7f4	2025-12-11	Warnings	Exact identifier application number: M013
Midol Complete, Travel BASIX	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE	Lil' Drug Store Products, Inc	d6d47af8-5f8c-4c8c-a8c6-aa214ec23bca	2025-12-10	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength, CVP HEALTH	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	643371f2-e330-441e-8932-b3aec4b179d2	2025-12-10	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	United Natural Foods, Inc. dba UNFI	18b79449-5c4c-41ce-9609-80f5efa0375c	2025-12-09	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	36ad34f4-4e66-f371-e063-6394a90ae76a	2025-12-09	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	LIDL US LLC	ec543339-20ab-2cba-e053-2995a90ac740	2025-12-09	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	c57c10fc-f182-4153-8974-ef359a5f5ac1	2025-12-09	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	HEB	f7958347-4e9c-4698-8749-7ca7023ee2ba	2025-12-09	Warnings	Exact identifier application number: M013
Pain Relief Rapid Release Gelcaps Extra Strength	ACETAMINOPHEN	Safeway	c830d1ac-c4c5-4eb1-98bb-22707cb6db91	2025-12-09	Warnings	Exact identifier application number: M013
Menstrual Pain Relief Complete	ACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINE	Shield Pharmaceuticals Corp	5efd6c61-74ed-4253-896a-e4a40bd8f25b	2025-12-09	Warnings	Exact identifier application number: M013
Excedrin Extra Strength, TRAVEL BASIX	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil Drug Store Products, Inc	7f0f8b3c-c226-4a3a-af46-a708f345e4f5	2025-12-09	Warnings	Exact identifier application number: M013
childrens acetaminophen	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	f65203a2-64f0-4138-97e4-6eab99194178	2025-12-09	Warnings	Exact identifier application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATED	Lil' Drug Store Products, Inc.	45735cd8-ac07-3f12-e063-6294a90a0cb2	2025-12-08	Warnings	Exact identifier application number: M013
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN	ACETAMINOPHEN	BJWC	e27b6637-ef32-44b5-a531-b6617d02fbbf	2025-12-08	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALGREENS	3f9f1740-9e8b-6a2d-e063-6294a90a67cb	2025-12-06	Warnings	Exact identifier application number: M013
Bayer Rapid Relief	ASPIRIN/CAFFEINE ORAL POWDER	Bayer HealthCare LLC.	f1fecbb0-5b55-fe8f-e053-2995a90a0977	2025-12-05	Warnings	Exact identifier application number: M013
Headache Relief, Extra Strength 24/7 Life by 7-Eleven	ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATED	Lil' Drug Store Products, Inc.	45381b1c-2acd-1524-e063-6394a90a83d9	2025-12-05	Warnings	Exact identifier application number: M013
Acetaminophen Easy Tabs Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	729132cd-f209-447a-8949-a90b5a5c01da	2025-12-05	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	7faf76b4-7f25-377d-e053-2a91aa0a19d4	3
1100005	CounterAct Pain 500 MG Oral Tablet	PSN	7faf76b4-7f25-377d-e053-2a91aa0a19d4	3
1100005	acetaminophen 500 MG Oral Tablet [CounterAct Pain]	SBD	7faf76b4-7f25-377d-e053-2a91aa0a19d4	3
198440	acetaminophen 500 MG Oral Tablet	SCD	7faf76b4-7f25-377d-e053-2a91aa0a19d4	3
198440	APAP 500 MG Oral Tablet	SY	7faf76b4-7f25-377d-e053-2a91aa0a19d4	3
1100005	APAP 500 MG Oral Tablet [CounterAct Pain]	SY	7faf76b4-7f25-377d-e053-2a91aa0a19d4	3
1100005	CounterAct Pain 500 MG Oral Tablet	SY	7faf76b4-7f25-377d-e053-2a91aa0a19d4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54473-305-50	54473030550	1 BOTTLE in 1 BOX (54473-305-50) / 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2018-01-01	0000-00-00	No	No	Current