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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440, 1100005

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-305-502025-03-21C16284748780-12cef2736-aae7-d83d-e063-dadaa90ab31fCounterAct Pain Content of Labeling
54473-305-502025-01-30C16284748780-12cef2736-aae7-d83d-e063-dadaa90ab31fCounterAct Pain Content of Labeling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-305-50CounterActPain50 in 1 BOTTLETABLET, FILM COATED503
54473-305-50CounterActPain1 in 1 BOXTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-305COUNTERACT PAIN (ACETAMINOPHEN) TABLET, FILM COATED [MELALEUCA, INC.]3Current NDC, Legacy NDC, 2 package rows20250323_7faf76b4-7f25-377d-e053-2a91aa0a19d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN7faf76b4-7f25-377d-e053-2a91aa0a19d43
1100005CounterAct Pain 500 MG Oral TabletPSN7faf76b4-7f25-377d-e053-2a91aa0a19d43
1100005acetaminophen 500 MG Oral Tablet [CounterAct Pain]SBD7faf76b4-7f25-377d-e053-2a91aa0a19d43
198440acetaminophen 500 MG Oral TabletSCD7faf76b4-7f25-377d-e053-2a91aa0a19d43
198440APAP 500 MG Oral TabletSY7faf76b4-7f25-377d-e053-2a91aa0a19d43
1100005APAP 500 MG Oral Tablet [CounterAct Pain]SY7faf76b4-7f25-377d-e053-2a91aa0a19d43
1100005CounterAct Pain 500 MG Oral TabletSY7faf76b4-7f25-377d-e053-2a91aa0a19d43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-305-50544730305501 BOTTLE in 1 BOX (54473-305-50) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-01-010000-00-00NoNoCurrent