FDA.reportPublic FDA data

Pain Relief

Product NDC
55910-812
11-digit product format
559100812
Labeler code
55910
Product ID
55910-812_ff0f7223-4a62-4f38-99d0-d108f13a8e9a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DOLGENCORP, LLC
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 Relief
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
55910-812-08Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED120
55910-812-08Pain ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED2420
55910-812-32Pain ReliefExtra Strength120 in 1 BOTTLE, PLASTICTABLET, COATED12020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
GELATININACTIVE INGREDIENT2G86QN327LEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-812PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [DOLGENCORP, LLC]19Current NDC, Legacy NDC, 3 package rows20240608_ce9f4e0d-43fb-499a-b8a2-a997a14841c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNce9f4e0d-43fb-499a-b8a2-a997a14841c420
198440acetaminophen 500 MG Oral TabletSCDce9f4e0d-43fb-499a-b8a2-a997a14841c420
198440APAP 500 MG Oral TabletSYce9f4e0d-43fb-499a-b8a2-a997a14841c420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-812-08559100812081 BOTTLE, PLASTIC in 1 CARTON (55910-812-08) > 24 TABLET in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
55910-812-3255910081232120 TABLET, COATED in 1 BOTTLE, PLASTIC (55910-812-32) 2004-05-100000-00-00NoNoCurrent