FDA.reportPublic FDA data

Pain Relief

Product NDC
83324-081
11-digit product format
833240081
Labeler code
83324
Product ID
83324-081_1ac6e721-4d0a-0396-e063-6294a90a7fe9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-26
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Listing expiration
2026-12-31

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
cfaf9495-e654-4dfc-ba23-d2358c3720c4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-081-01Pain ReliefExtra Strength100 in 1 PACKAGETABLET1002
83324-081-01Pain ReliefExtra Strength1 in 1 CARTONTABLET12
83324-081-10Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET1002
83324-081-60Pain ReliefExtra Strength60 in 1 BOTTLE, PLASTICTABLET602
83324-081-60Pain ReliefExtra Strength1 in 1 CARTONTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-081-01EA - Each83324-081e54beb91-3e2c-4ee4-93be-0ea7ee0c454a12026-01-08
83324-081-10EA - Each83324-0812b7a8e0d-06af-48b6-9c17-b2bd7bccc12112026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-081PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2Current NDC, 5 package rows20240615_cfaf9495-e654-4dfc-ba23-d2358c3720c4.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 14 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain RelieverACETAMINOPHENHHH Pharmaceuticals0c66b05d-132d-4c79-abfe-415fd68bbb9c2026-05-06WarningsExact identifier
application number: M013
AspirinASPIRINBetter Living Brands, LLC5ebd04d8-52c7-4c72-a4c1-fc7fd488ea242026-05-06WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINECardinal Health 110, LLC. DBA Leader519eb216-9fa6-4d60-a2a4-3310bdb5b4ab2026-05-06WarningsExact identifier
application number: M013
AspirinASPIRINGeiss, Destin & Dunn Inc.b8f6e486-5332-4c46-ab6c-7de04c91c60b2026-05-06WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDRENS ACETAMINOPHENATLANTIC BIOLOGICALS CORP.c60494f0-5a50-41da-bcb4-88178ded54b72026-05-05WarningsExact identifier
application number: M013
equate pain relief pmACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.85129749-c1a7-4c4a-933f-c3c4768e2cdd2026-05-05WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICEf3feca65-adc1-469f-bef6-12c860599abe2026-05-04WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENStrategic Sourcing Services LLC4dda3534-4e83-447b-be75-33dadce06c472026-05-04WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINMajor Pharmaceuticals4ba6eed3-004a-4576-b7f7-685fae49cf6a2026-05-04WarningsExact identifier
application number: M013
Back and BodyASPIRIN, CAFFEINEKroger Company366b58db-1ac3-427b-b42a-5f56a14e298c2026-05-01WarningsExact identifier
application number: M013
Tylenol PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8ed9a9f0-d37e-5c10-e053-2a95a90a559f2026-05-01WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENSavings Distributors LLC8ed90757-833e-f4d9-e053-2995a90a29db2026-05-01WarningsExact identifier
application number: M013
Acetaminophen , Aspirin and CaffeineACETAMINOPHEN , ASPIRIN AND CAFFEINESoftgel Healthcare Pvt Ltd4543e156-1deb-666e-e063-6394a90a719c2026-04-27WarningsExact identifier
application number: M013
Acetaminophen , Caffeine and pyrilamine maleateACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATESoftgel Healthcare Pvt Ltd45478958-ad86-4d87-e063-6394a90a3c452026-04-27WarningsExact identifier
application number: M013
Medique at Home AspirinASPIRINSportpharm LLC0f2aa75e-534f-478b-811e-fb492b7af9bb2026-04-24WarningsExact identifier
application number: M013
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGSportpharm LLCcc280926-ad94-4017-a04a-b4315807eacb2026-04-24WarningsExact identifier
application number: M013
AspirinASPIRINHealth Pharma USA LLC503868bb-48e0-b718-e063-6394a90a9c5b2026-04-24WarningsExact identifier
application number: M013
BC CHERRYASPIRIN AND CAFFEINEMedtech Products Inc.c5fa6660-a549-49ff-ac2b-5799afa22ec52026-04-24WarningsExact identifier
application number: M013
Doans Maximum StrengthMAGNESIUM SALICYLATEDr. Reddy's Laboratories Inc.c906df41-bb45-03ea-b1a8-2b9816d55c972026-04-24WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.48912649-9fa1-a11f-e063-6294a90a8a722026-04-23WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNcfaf9495-e654-4dfc-ba23-d2358c3720c42
198440acetaminophen 500 MG Oral TabletSCDcfaf9495-e654-4dfc-ba23-d2358c3720c42
198440APAP 500 MG Oral TabletSYcfaf9495-e654-4dfc-ba23-d2358c3720c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-081-01833240081011 PACKAGE in 1 CARTON (83324-081-01) / 100 TABLET in 1 PACKAGE1 package2024-04-26NoNoCurrent
83324-081-1083324008110100 TABLET in 1 BOTTLE, PLASTIC (83324-081-10) 100 tablet2024-06-12NoNoCurrent
83324-081-60833240081601 BOTTLE, PLASTIC in 1 CARTON (83324-081-60) / 60 TABLET in 1 BOTTLE, PLASTIC2024-04-26NoNoCurrent