Pain Reliever

Product NDC
50844-519
11-digit product format
508440519
Labeler code
50844
Product ID
50844-519_9f5e3344-4f7b-4096-a4f0-929e140c175c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-05-10
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
50844-519-02Pain RelieverExtra Strength12 in 1 BOTTLE, PLASTICTABLET, COATED1217
50844-519-02Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED117
50844-519-12Pain RelieverExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED10017
50844-519-15Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED117
50844-519-15Pain RelieverExtra Strength50 in 1 BOTTLETABLET, COATED5017
50844-519-20Pain RelieverExtra Strength225 in 1 BOTTLE, PLASTICTABLET, COATED22517
50844-519-21Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED117
50844-519-21Pain RelieverExtra Strength16 in 1 BOTTLE, PLASTICTABLET, COATED1617

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-519PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]16Current NDC, Legacy NDC, 8 package rows20241109_72babe91-2586-4f05-ae90-6debfd23aa5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN72babe91-2586-4f05-ae90-6debfd23aa5d17
198440acetaminophen 500 MG Oral TabletSCD72babe91-2586-4f05-ae90-6debfd23aa5d17
198440APAP 500 MG Oral TabletSY72babe91-2586-4f05-ae90-6debfd23aa5d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-519-02508440519021 BOTTLE, PLASTIC in 1 CARTON (50844-519-02) > 12 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
50844-519-1250844051912100 TABLET, COATED in 1 BOTTLE, PLASTIC (50844-519-12) 2023-11-14NoNoCurrent
50844-519-15508440519151 BOTTLE in 1 CARTON (50844-519-15) > 50 TABLET in 1 BOTTLE1 bottle2004-05-100000-00-00NoNoCurrent
50844-519-2050844051920225 TABLET, COATED in 1 BOTTLE, PLASTIC (50844-519-20) 2023-11-14NoNoCurrent
50844-519-21508440519211 BOTTLE, PLASTIC in 1 CARTON (50844-519-21) / 16 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent