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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5de40821-3218-4320-bf11-9493bf01d489Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 72 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolex Children Pain and FeverACETAMINOPHENPharmadel LLCf9158463-aeb1-5de0-e053-6294a90a748b2024-03-04WarningsExact identifier
application number: M013
SEDALMEX FORTEACETAMINOPHEN, ASPIRIN, CAFFEINEBelmora LLC33b3508e-4caa-4d05-9b15-cb82a2ee2d4d2024-02-28WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAMERISOURCE BERGEN2b923a97-836c-4dac-a8c0-3047a35fb62e2024-02-23WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBJWC (Berkley & Jensen / BJ's)b20a08f3-c9c0-4bd9-8ce0-acb932b5bb862024-02-22WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack31a41976-7f65-42d7-acf5-de9c2c5ca58e2024-02-20WarningsExact identifier
application number: M013
Publix Fast Relief Effervescent - Original FlavorASPIRINPUBLIX SUPER MARKETS INC.0a342f72-45fd-3e12-e063-6394a90ae33e2024-02-16WarningsExact identifier
application number: M013
Equaline Effervescent Pain RelieverASPIRINUNITED NATURAL FOODS, INC. DBA UNFI0761299a-e913-7665-e063-6394a90a60032024-02-16WarningsExact identifier
application number: M013
TopCare Effervescent Pain ReliefASPIRINTOPCO ASSOCIATES LLC075f36e1-110c-e839-e063-6294a90a89d72024-02-16WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.115d0b4f-6f0f-79a9-e063-6394a90ab18a2024-02-14WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLCe1799765-c247-42b4-ad6a-8ba7d136abf22024-02-06WarningsExact identifier
application number: M013
Panadol Cold and Flu NonDrowsyACETAMINOPHEN AND PHENYLEPRINE HCLHaleon US Holdings LLCf626ab17-01c9-4493-ba9e-0c8c111463842024-02-06WarningsExact identifier
application number: M013
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLC95801755-db54-4ad7-bec1-52671914f6ca2024-02-06WarningsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
application number: M013
Quality Choice Effervescent Pain ReliefASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.079af5d7-1be8-2a93-e063-6294a90a496d2024-02-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
application number: M013

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