FDA.reportPublic FDA data

Pain Relief

Product NDC
59726-494
11-digit product format
597260494
Labeler code
59726
Product ID
59726-494_911f8255-5be5-4012-b398-f2c9e74dc4a8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
P & L Development, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-31
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
59eb14a5-40b0-4331-beb5-7166e6cdf411Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-494-05Pain ReliefExtra Strength1 in 1 BOXTABLET110
59726-494-05Pain ReliefExtra Strength500 in 1 BOTTLE, PLASTICTABLET50010
59726-494-10Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET10010
59726-494-24Pain ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET2410
59726-494-24Pain ReliefExtra Strength1 in 1 BOXTABLET110
59726-494-50Pain ReliefExtra Strength50 in 1 BOTTLE, PLASTICTABLET5010
59726-494-50Pain ReliefExtra Strength1 in 1 BOXTABLET110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-494PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [P & L DEVELOPMENT, LLC]9Current NDC, Legacy NDC, 7 package rows20240418_59eb14a5-40b0-4331-beb5-7166e6cdf411.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 51 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bayer Genuine AspirinBAYER GENUINE ASPIRINLil' Drug Store Products, Inc.d17834d7-cb3e-6bf2-e053-2a95a90ae5c12024-12-30WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN 500 MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fd2b46-683e-4cf5-e053-2995a90a55122024-12-30WarningsExact identifier
application number: M013
Night Time Severe Cold and Cough ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLChain Drug Consortium, LLCc8e9b57b-83e9-46c5-9791-02c4c2b940042024-12-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC.1608b4f0-bf20-4024-b8f2-20a4df7a4b212024-12-26WarningsExact identifier
application number: M013
AspirinASPIRINAdvance Pharmaceutical Inc.f6a9ea44-08b8-4a33-bfbd-68cb2d852c392024-12-26WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCcfc7eac3-35be-4002-b8ef-be1dfc8caf692024-12-26WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCa3031139-4709-43f2-95a8-89840c595f7f2024-12-26WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGWALGREENS CO.98bb28ed-d146-ca3d-e053-2a95a90a9eaf2024-12-26WarningsExact identifier
application number: M013
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mgACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MGWALGREENS CO.982faa74-d498-cd1e-e053-2995a90afa1e2024-12-25WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.11bf6e1b-aed9-4f8f-9f03-ea911ae9f7022024-12-23WarningsExact identifier
application number: M013
Rugby Regular Strength AcetaminophenACETAMINOPHENRUGBY LABORATORIES295b0d00-4d4a-405f-9325-d01c5d4f3ed42024-12-20WarningsExact identifier
application number: M013
Walgreens Pain Relief PowderASPIRIN AND CAFFEINEWalgreens Co.61493d34-2432-4683-9b32-e1851a4337be2024-12-18WarningsExact identifier
application number: M013
Reese Headache PowdersASPIRIN AND CAFFEINEReese Pharmaceutical Co386f7a6c-4bfc-4140-a67b-07f6b520d58f2024-12-18WarningsExact identifier
application number: M013
NobleAid PAIN RELIEVERASPIRINNoble Otc LLCaa08e488-2f69-4d7e-86ba-ccfad563edcf2024-12-18WarningsExact identifier
application number: M013
Dollar General Headache PowdersASPIRIN AND CAFFEINEDolgencorp, LLC11b0271b-d65c-49c4-a081-d71044a0e04c2024-12-18WarningsExact identifier
application number: M013
Family Wellness Pain Relief PowderASPIRIN AND CAFFEINEFamily Dollar Services Incb2e55de7-3c36-49cc-8f7f-1013fd1ec3592024-12-18WarningsExact identifier
application number: M013
Best Choice Pain Relief PowderASPIRIN AND CAFFEINEValue Mercha95b9b22-ea5c-4a02-b35d-c8ae1e1176042024-12-18WarningsExact identifier
application number: M013
Walmart Pain Relief PowderASPIRIN AND CAFFEINEWalmartc69aa61f-6a74-40a3-8737-195fa545e2612024-12-18WarningsExact identifier
application number: M013
Quality Choice Pain Relief PowderASPIRIN AND CAFFEINEChain Drug Marketing Association8e1f4057-4968-4523-9b3f-55aea421b6742024-12-18WarningsExact identifier
application number: M013
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN59eb14a5-40b0-4331-beb5-7166e6cdf41110
198440acetaminophen 500 MG Oral TabletSCD59eb14a5-40b0-4331-beb5-7166e6cdf41110
198440APAP 500 MG Oral TabletSY59eb14a5-40b0-4331-beb5-7166e6cdf41110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-494-05597260494051 BOTTLE, PLASTIC in 1 BOX (59726-494-05) / 500 TABLET in 1 BOTTLE, PLASTIC2016-03-312026-12-31NoNoCurrent
59726-494-1059726049410100 TABLET in 1 BOTTLE, PLASTIC (59726-494-10) 100 tablet2016-03-312026-12-31NoNoCurrent
59726-494-24597260494241 BOTTLE, PLASTIC in 1 BOX (59726-494-24) / 24 TABLET in 1 BOTTLE, PLASTIC2016-03-312026-12-31NoNoCurrent
59726-494-50597260494501 BOTTLE, PLASTIC in 1 BOX (59726-494-50) / 50 TABLET in 1 BOTTLE, PLASTIC2016-03-312026-12-31NoNoCurrent