FDA.reportPublic FDA data

Pain Reliever

Product NDC
0363-0175
11-digit product format
003630175
Labeler code
0363
Product ID
0363-0175_6434fb16-8cb8-4220-8e85-d9ca1ff51d56
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-04-02
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
Pain Reliever
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
0363-0175-03Pain RelieverExtra Strength10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1025
0363-0175-08Pain RelieverExtra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2425
0363-0175-08Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-12Pain RelieverExtra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10025
0363-0175-12Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-14Pain RelieverExtra Strength500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50025
0363-0175-15Pain RelieverExtra Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5025
0363-0175-15Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-20Pain RelieverExtra Strength225 in 1 BOTTLE, PLASTICTABLET, FILM COATED22525
0363-0175-20Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-29Pain RelieverExtra Strength150 in 1 BOTTLE, PLASTICTABLET, FILM COATED15025
0363-0175-37Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-37Pain RelieverExtra Strength75 in 1 BOTTLE, PLASTICTABLET, FILM COATED7525
0363-0175-57Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-57Pain RelieverExtra Strength125 in 1 BOTTLE, PLASTICTABLET, FILM COATED12525
0363-0175-99Pain RelieverExtra Strength1 in 1 CARTONTABLET, FILM COATED125
0363-0175-99Pain RelieverExtra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2425

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0175-08EA - Each0363-01751785b67f-dae5-4bd7-bf49-2a18c917a43e12012-07-24
0363-0175-12EA - Each0363-0175080c808e-3a8b-4c5a-af0b-4434d903ebe412012-07-24
0363-0175-14EA - Each0363-0175f746f447-21e4-460f-9c02-1cd1136c4b1612012-07-24
0363-0175-15EA - Each0363-01757ab0b567-db1d-444e-81aa-21757e7a18cf12012-07-24
0363-0175-20EA - Each0363-017542a2211c-bd60-46b4-8d2b-42ceba0f637b12024-04-05
0363-0175-29EA - Each0363-01752ae5278f-300e-48a0-851e-4d1feb4cb91612012-07-24
0363-0175-37EA - Each0363-01753d03849d-5174-498a-8e5c-3e4507212a0412024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]10
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]10
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]10
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]10
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0175PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN COMPANY]24Current NDC, Legacy NDC, 17 package rows20250108_f7667529-09c0-4603-8080-f236144fac36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNf7667529-09c0-4603-8080-f236144fac3625
198440acetaminophen 500 MG Oral TabletSCDf7667529-09c0-4603-8080-f236144fac3625
198440APAP 500 MG Oral TabletSYf7667529-09c0-4603-8080-f236144fac3625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0175-030036301750310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0175-03) 1993-04-020000-00-00NoNoCurrent
0363-0175-08003630175081 BOTTLE, PLASTIC in 1 CARTON (0363-0175-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
0363-0175-12003630175121 BOTTLE, PLASTIC in 1 CARTON (0363-0175-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
0363-0175-1400363017514500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0175-14) 1993-04-020000-00-00NoNoCurrent
0363-0175-15003630175151 BOTTLE, PLASTIC in 1 CARTON (0363-0175-15) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
0363-0175-20003630175201 BOTTLE, PLASTIC in 1 CARTON (0363-0175-20) > 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent
0363-0175-2900363017529150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0175-29) 1993-04-020000-00-00NoNoCurrent
0363-0175-37003630175371 in 1 CARTONHistorical
0363-0175-57003630175571 in 1 CARTONHistorical
0363-0175-99003630175991 BOTTLE, PLASTIC in 1 CARTON (0363-0175-99) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1993-04-020000-00-00NoNoCurrent