FDA.reportPublic FDA data

Acetaminophen

Product NDC
41163-500
11-digit product format
411630500
Labeler code
41163
Product ID
41163-500_24b0d399-5710-8baf-e063-6394a90aa1a5
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-01
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
41163-500-01AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-01AcetaminophenExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED247
41163-500-02AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-02AcetaminophenExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED507
41163-500-04AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-04AcetaminophenExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1007
41163-500-05AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-05AcetaminophenExtra Strength250 in 1 BOTTLE, PLASTICTABLET, COATED2507
41163-500-06AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-06AcetaminophenExtra Strength500 in 1 BOTTLE, PLASTICTABLET, COATED5007
41163-500-17AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
41163-500-17AcetaminophenExtra Strength150 in 1 BOTTLE, PLASTICTABLET, COATED1507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-500-01EA - Each41163-5000542addf-a02a-45b0-8a77-7783fffc3d7312016-10-06
41163-500-04EA - Each41163-50072c2c122-7bbb-4568-a416-72e343402b0212016-06-14
41163-500-05EA - Each41163-5000acacb01-4dc9-4044-a453-22324f44f44112016-10-06
41163-500-06EA - Each41163-5002dd86359-09a8-49cb-a882-ebe40b927df912016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-500ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [UNITED NATURAL FOODS, INC. DBA UNFI]7Current NDC, Legacy NDC, 12 package rows20241019_f3db8598-fe0e-4c53-a023-5f5f8f002cc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNf3db8598-fe0e-4c53-a023-5f5f8f002cc67
198440acetaminophen 500 MG Oral TabletSCDf3db8598-fe0e-4c53-a023-5f5f8f002cc67
198440APAP 500 MG Oral TabletSYf3db8598-fe0e-4c53-a023-5f5f8f002cc67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-500-01411630500011 BOTTLE, PLASTIC in 1 CARTON (41163-500-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2013-11-010000-00-00NoNoCurrent
41163-500-02411630500021 in 1 CARTONHistorical
41163-500-04411630500041 BOTTLE, PLASTIC in 1 CARTON (41163-500-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2013-11-010000-00-00NoNoCurrent
41163-500-05411630500051 in 1 CARTONHistorical
41163-500-06411630500061 BOTTLE, PLASTIC in 1 CARTON (41163-500-06) / 500 TABLET, COATED in 1 BOTTLE, PLASTIC2013-11-010000-00-00NoNoCurrent
41163-500-17411630500171 in 1 CARTONHistorical