FDA.reportPublic FDA data

Pain Relief

Product NDC
63868-507
11-digit product format
638680507
Labeler code
63868
Product ID
63868-507_243562aa-4855-9d50-e063-6394a90a7cac
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-08-14
Marketing end
2026-12-31
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief
Brand name suffix
Extra Strength

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
63868-507-01Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13
63868-507-01Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-507-01EA - Each63868-507aeb03cf1-4940-48d3-b7ea-eb54bdfed59512014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-507PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]3Current NDC, Legacy NDC, 2 package rows20241013_5de40821-3218-4320-bf11-9493bf01d489.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN5de40821-3218-4320-bf11-9493bf01d4893
198440acetaminophen 500 MG Oral TabletSCD5de40821-3218-4320-bf11-9493bf01d4893
198440APAP 500 MG Oral TabletSY5de40821-3218-4320-bf11-9493bf01d4893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-507-01638680507011 BOTTLE, PLASTIC in 1 CARTON (63868-507-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2007-08-142026-12-31NoNoCurrent