FDA.reportPublic FDA data

Acetaminophen

Product NDC
81522-104
11-digit product format
815220104
Labeler code
81522
Product ID
81522-104_24996677-f6f7-01be-e063-6394a90a10d7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
FSA Store Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-11
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
Acetaminophen
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-104-04AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED14
81522-104-04AcetaminophenExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1004
81522-104-06AcetaminophenExtra Strength500 in 1 BOTTLE, PLASTICTABLET, COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-104ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [FSA STORE INC.]4Current NDC, Legacy NDC, 3 package rows20241018_ec6add55-f4a3-7818-e053-2a95a90aee04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNec6add55-f4a3-7818-e053-2a95a90aee044
198440acetaminophen 500 MG Oral TabletSCDec6add55-f4a3-7818-e053-2a95a90aee044
198440APAP 500 MG Oral TabletSYec6add55-f4a3-7818-e053-2a95a90aee044

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81522-104-04815220104041 BOTTLE, PLASTIC in 1 CARTON (81522-104-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2023-01-110000-00-00NoNoCurrent
81522-104-0681522010406500 TABLET, COATED in 1 BOTTLE, PLASTIC (81522-104-06) 2023-05-03NoNoHistorical