FDA.reportPublic FDA data

Acetaminophen

Product NDC
69842-915
11-digit product format
698420915
Labeler code
69842
Product ID
69842-915_6c2f95cf-5a97-42fc-bf5b-4810ff3799a3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CVS PHARMACY
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-20
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

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
69842-915-05AcetaminophenExtra Strength400 in 1 BOTTLE, PLASTICTABLET, COATED40011
69842-915-08AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED111
69842-915-08AcetaminophenExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED2411
69842-915-12AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED111
69842-915-12AcetaminophenExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED10011
69842-915-15AcetaminophenExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED5011
69842-915-15AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED111
69842-915-20AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED111
69842-915-20AcetaminophenExtra Strength225 in 1 BOTTLE, PLASTICTABLET, COATED22511
69842-915-29AcetaminophenExtra Strength150 in 1 BOTTLE, PLASTICTABLET, COATED15011
69842-915-78AcetaminophenExtra Strength600 in 1 BOTTLE, PLASTICTABLET, COATED60011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-915ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CVS PHARMACY]10Current NDC, Legacy NDC, 11 package rows20250406_af6fe4a9-2d18-4fed-b952-0a7866f65251.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNaf6fe4a9-2d18-4fed-b952-0a7866f6525111
198440acetaminophen 500 MG Oral TabletSCDaf6fe4a9-2d18-4fed-b952-0a7866f6525111
198440APAP 500 MG Oral TabletSYaf6fe4a9-2d18-4fed-b952-0a7866f6525111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-915-0569842091505400 TABLET, COATED in 1 BOTTLE, PLASTIC (69842-915-05) 2020-02-200000-00-00NoNoCurrent
69842-915-08698420915081 BOTTLE, PLASTIC in 1 CARTON (69842-915-08) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2020-02-200000-00-00NoNoCurrent
69842-915-12698420915121 BOTTLE, PLASTIC in 1 CARTON (69842-915-12) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC2020-02-200000-00-00NoNoCurrent
69842-915-15698420915151 BOTTLE, PLASTIC in 1 CARTON (69842-915-15) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2020-02-200000-00-00NoNoCurrent
69842-915-20698420915201 BOTTLE in 1 CARTON (69842-915-20) > 225 TABLET in 1 BOTTLE1 bottle2020-02-200000-00-00NoNoCurrent
69842-915-2969842091529150 TABLET in 1 BOTTLE (69842-915-29) 150 tablet2020-02-200000-00-00NoNoCurrent
69842-915-7869842091578600 TABLET, COATED in 1 BOTTLE, PLASTIC (69842-915-78) 2020-02-200000-00-00NoNoCurrent