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 40 of 79 · 1,561 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	caf5daea-409e-5dd2-e053-2995a90acb12	2025-08-18	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief 100	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c42e48d-cdb2-eb74-e063-6394a90a2940	2025-08-13	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c477d33-a8c2-d39f-e063-6294a90ac5f0	2025-08-13	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	CHAIN DRUG MARKETING ASSOCIATION INC	4005f8dd-3050-4590-8703-6997444e8df3	2025-08-13	Warnings	Exact identifier application number: M013
good sense headache relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	L. Perrigo Company	4cae0580-7ee3-4f38-8d13-79c7d7615f8f	2025-08-12	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	3bb7dc60-97b2-1291-e063-6294a90a26d9	2025-08-12	Warnings	Exact identifier application number: M013
Dr Simi Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Farmacias De Similares TX LLC	3c19ad99-6e0f-3116-e063-6394a90a914c	2025-08-11	Warnings	Exact identifier application number: M013
good sense pain relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	3c1f505d-0319-a179-e063-6294a90a0b17	2025-08-11	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PROSTAT FIRST AID	3bdb9d89-9000-69f9-e063-6294a90a0c97	2025-08-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Prostat First Aid	3bdbea6a-3f11-9142-e063-6294a90a20ea	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	A-S Medication Solutions	8575ef9d-2eae-412a-a252-82b03f4d5275	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	7a91b1df-8d6d-4205-9822-bc4d800555f7	2025-08-08	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	3d6bf733-800c-420a-a9ab-ae4a26134799	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	44b8c203-37c5-425e-9110-f7eb614f9c2d	2025-08-08	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION INC	c46688ec-e976-4f76-9265-645f59970ff5	2025-08-06	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	P & L Development, LLC	c54ad829-f2e8-4367-b439-af20b0ef8ad2	2025-08-06	Warnings	Exact identifier application number: M013
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	398d8996-b522-a3cd-e063-6394a90ac2c8	2025-08-06	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Marlex Pharmaceuticals Inc.	cc7013ea-cf30-6f59-e053-2a95a90a1148	2025-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Prostat First Aid	3ba313db-bafe-1947-e063-6294a90a528c	2025-08-05	Warnings	Exact identifier application number: M013
MEDIQUE APAP acetaminophen	MEDIQUE APAP ACETAMINOPHEN	HF Acquisition Co LLC, DBA HealthFirst	3ba5c802-fe5a-e42a-e063-6394a90ae67e	2025-08-05	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