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

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 29 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYf7e87eac-59fb-4a72-b5c6-02953112be6a2025-12-11WarningsExact identifier
application number: M013
AspirinASPIRINVALU MERCHANDISERS COMPANY049ec1aa-66b3-9273-e063-6294a90a221b2025-12-11WarningsExact identifier
application number: M013
Aspirin 325ASPIRINWalgreen Companyf7a5d612-443c-4701-ad3b-8eb53c87bece2025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma355a094c-bed9-4959-8cf0-619f0e2461052025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmafac4e0c6-684f-45a1-99f2-de4de4017cc82025-12-11WarningsExact identifier
application number: M013
Pain Reliever PM extra strengthACETAMINOPHEN DIPHENHYDRAMINE HCLP & L Development, LLC90eba2e8-52c3-43f5-ba93-4a520368c7f42025-12-11WarningsExact identifier
application number: M013
Midol Complete, Travel BASIXACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATELil' Drug Store Products, Incd6d47af8-5f8c-4c8c-a8c6-aa214ec23bca2025-12-10WarningsExact identifier
application number: M013
Tylenol PM Extra Strength, CVP HEALTHACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.643371f2-e330-441e-8932-b3aec4b179d22025-12-10WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINUnited Natural Foods, Inc. dba UNFI18b79449-5c4c-41ce-9609-80f5efa0375c2025-12-09WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad34f4-4e66-f371-e063-6394a90ae76a2025-12-09WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENLIDL US LLCec543339-20ab-2cba-e053-2995a90ac7402025-12-09WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.c57c10fc-f182-4153-8974-ef359a5f5ac12025-12-09WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHEBf7958347-4e9c-4698-8749-7ca7023ee2ba2025-12-09WarningsExact identifier
application number: M013
Pain Relief Rapid Release Gelcaps Extra StrengthACETAMINOPHENSafewayc830d1ac-c4c5-4eb1-98bb-22707cb6db912025-12-09WarningsExact identifier
application number: M013
Menstrual Pain Relief CompleteACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINEShield Pharmaceuticals Corp5efd6c61-74ed-4253-896a-e4a40bd8f25b2025-12-09WarningsExact identifier
application number: M013
Excedrin Extra Strength, TRAVEL BASIXACETAMINOPHEN, ASPIRIN, AND CAFFEINELil Drug Store Products, Inc7f0f8b3c-c226-4a3a-af46-a708f345e4f52025-12-09WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf65203a2-64f0-4138-97e4-6eab991941782025-12-09WarningsExact identifier
application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45735cd8-ac07-3f12-e063-6294a90a0cb22025-12-08WarningsExact identifier
application number: M013
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHENACETAMINOPHENBJWCe27b6637-ef32-44b5-a531-b6617d02fbbf2025-12-08WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS3f9f1740-9e8b-6a2d-e063-6294a90a67cb2025-12-06WarningsExact 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