FDA.reportPublic FDA data

Pain Reliever

Product NDC
68016-543
11-digit product format
680160543
Labeler code
68016
Product ID
68016-543_913edec4-45ba-48bd-8da0-23f38da8fd6a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Consortium
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-29
Marketing end
2026-11-30
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 Reliever

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
60d4b392-6ed0-4115-8154-24eaf72504a5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-543-01Pain Reliever100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
68016-543-01Pain Reliever1 in 1 CARTONTABLET, FILM COATED15
68016-543-24Pain Reliever1 in 1 CARTONTABLET, FILM COATED15
68016-543-24Pain Reliever24 in 1 BOTTLE, PLASTICTABLET, FILM COATED245
68016-543-99Pain Reliever1 in 1 CARTONTABLET, FILM COATED15
68016-543-99Pain Reliever225 in 1 BOTTLE, PLASTICTABLET, FILM COATED2255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-543PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]4Current NDC, Legacy NDC, 6 package rows20240420_60d4b392-6ed0-4115-8154-24eaf72504a5.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 35 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodys Cool Orange HeadacheACETAMINOPHEN AND ASPIRIN AND CAFFEINEMedtech Products Inc.31212c97-9975-427e-bc3d-f7125f30299a2025-10-23WarningsExact identifier
application number: M013
BC ArthritisASPIRIN AND CAFFEINEMedtech Products Inc.3a85be2d-6548-4de5-8109-60e1ca2bfca32025-10-23WarningsExact identifier
application number: M013
Goodys Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.d4325b17-23bc-44ac-868d-bb0886853a732025-10-23WarningsExact identifier
application number: M013
BCASPIRIN AND CAFFEINEMedtech Products Inc.226173d4-b6d5-4fe6-b24e-1cc5d1b31c882025-10-23WarningsExact identifier
application number: M013
BC MAXASPIRIN, ACETAMINOPHEN, CAFFEINEMedtech Products Inc.1e2a07ab-23e6-49b4-a676-212dc6880f142025-10-23WarningsExact identifier
application number: M013
Ecotrin Regular StrengthASPIRINMedtech Products Inc.36cb530b-25b2-4f62-a25d-aa04360815a82025-10-23WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENTOPCO ASSOCIATES LLCbbc367cc-6c79-498e-8fca-1347e6ea1a8c2025-10-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRugby Laboratoriesb16ed4ef-689c-4df2-ab6c-207aa8b9925d2025-10-22WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINETIME CAP LABS INC05364eb4-07a1-a4d9-e063-6294a90a47e52025-10-21WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacy, Inc.6deb854f-863e-24ad-e053-2991aa0afb172025-10-21WarningsExact identifier
application number: M013
BackAidACETAMINOPHEN, CAFFEINEKobayashi Healthcare International, Inc.25db6bb5-96b6-4be1-e063-6294a90a23002025-10-21WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENMethod Pharmaceuticals, LLC1539dc44-15a0-153b-e063-6294a90a9d452025-10-21WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENMethod Pharmaceuticals, LLC3d1bb61c-15db-4eba-aba9-cfbcbc7b30e02025-10-21WarningsExact identifier
application number: M013
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
application number: M013
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
application number: M013
Xesso NeoBENZOCAINEPREMIUM NATURAL COSMETICS INC163f32cd-4e51-950a-e063-6394a90a48162025-10-17WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECHAIN DRUG MARKETING ASSOCIATION INC913d8bdb-7644-464c-b9a6-55387ff120592025-10-17WarningsExact identifier
application number: M013
Alka-Seltzer Hangover ReliefANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.dc235b06-999e-221d-e053-2a95a90a0ce12025-10-16WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN ENTERIC COATED TABLETS 81MGVITANE PHARMACEUTICALS, INC41386de5-5857-efab-e063-6294a90afd9c2025-10-15WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN ENTERIC COATED TABLETS 81MGVITANE PHARMACEUTICALS, INC4138d4c0-baa5-1f20-e063-6394a90a788f2025-10-15WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN60d4b392-6ed0-4115-8154-24eaf72504a55
198440acetaminophen 500 MG Oral TabletSCD60d4b392-6ed0-4115-8154-24eaf72504a55
198440APAP 500 MG Oral TabletSY60d4b392-6ed0-4115-8154-24eaf72504a55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-543-01680160543011 BOTTLE, PLASTIC in 1 CARTON (68016-543-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2022-04-292026-11-30NoNoCurrent
68016-543-24680160543241 BOTTLE, PLASTIC in 1 CARTON (68016-543-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2022-04-292026-11-30NoNoCurrent
68016-543-99680160543991 BOTTLE, PLASTIC in 1 CARTON (68016-543-99) / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2022-04-292026-11-30NoNoHistorical