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 35 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BackAid	ACETAMINOPHEN, CAFFEINE	Kobayashi Healthcare International, Inc.	25db6bb5-96b6-4be1-e063-6294a90a2300	2025-10-21	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Method Pharmaceuticals, LLC	1539dc44-15a0-153b-e063-6294a90a9d45	2025-10-21	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Method Pharmaceuticals, LLC	3d1bb61c-15db-4eba-aba9-cfbcbc7b30e0	2025-10-21	Warnings	Exact identifier application number: M013
Walgreens Antacid Pain Relief Extra Strength	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walgreens	b60df498-07db-500b-e053-2a95a90aff6a	2025-10-17	Warnings	Exact identifier application number: M013
Equate Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walmart	6271b34b-55a0-40a8-e053-2a91aa0acb22	2025-10-17	Warnings, Adverse reactions	Exact identifier application number: M013
Xesso Neo	BENZOCAINE	PREMIUM NATURAL COSMETICS INC	163f32cd-4e51-950a-e063-6394a90a4816	2025-10-17	Warnings	Exact identifier application number: M013
Menstrual Complete Maximum Strength	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	CHAIN DRUG MARKETING ASSOCIATION INC	913d8bdb-7644-464c-b9a6-55387ff12059	2025-10-17	Warnings	Exact identifier application number: M013
Alka-Seltzer Hangover Relief	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	dc235b06-999e-221d-e053-2a95a90a0ce1	2025-10-16	Warnings	Exact identifier application number: M013
Aspirin 81mg	ASPIRIN ENTERIC COATED TABLETS 81MG	VITANE PHARMACEUTICALS, INC	41386de5-5857-efab-e063-6294a90afd9c	2025-10-15	Warnings	Exact identifier application number: M013
Aspirin 81mg	ASPIRIN ENTERIC COATED TABLETS 81MG	VITANE PHARMACEUTICALS, INC	4138d4c0-baa5-1f20-e063-6394a90a788f	2025-10-15	Warnings	Exact identifier application number: M013
TEXACLEAR PAIN RELIEVER	CAFFEINE, CHOLINE SALICYLATE	GM Pharmaceuticals, INC	065bd10c-3bcf-486f-a49c-40544127007f	2025-10-15	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	ASCLEMED USA INC.	db8e6702-88ac-4db2-9dd8-7d0ed997c2b5	2025-10-14	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Walgreen Company	fa33f6ef-522b-4630-9716-92371d9cd24a	2025-10-14	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	Rite Aid Corporation	a8bb4f45-7a1a-4bf7-92ca-3afd508032f3	2025-10-09	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Health Pharma USA LLC	b15a7dcb-f143-4aea-8850-d0aacbf709b6	2025-10-09	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PD-Rx Pharmaceuticals, Inc.	3f96aeb1-a533-4d36-9a1f-62fc094b6754	2025-10-08	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walgreens	f2eb9575-d527-44c7-aa5e-efabfd9a0278	2025-10-07	Warnings	Exact identifier application number: M013
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	bbc704e5-79f6-4c72-846b-cc30c5c43cb4	2025-10-07	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION INC	f1ce15a3-9824-4eb5-910a-39078165f385	2025-10-07	Warnings	Exact identifier application number: M013
BupropiDex	DEXTROMETHORPHAN HYDROBROMIDE	DXM Pharmacuetical, Inc.	90cc9bcd-7891-4324-a1f4-f6df7a0457e0	2025-10-06	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