FDA.reportPublic FDA data

TYLENOL

Product NDC
50580-495
11-digit product format
505800495
Labeler code
50580
Product ID
50580-495_25b09044-067e-eb90-e063-6394a90a6d21
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-01
Substance
ACETAMINOPHEN
Active strength
325 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
TYLENOL
Brand name suffix
Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209387Internal RxNorm lookup
313782Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de5c6654-56c5-40d3-a286-f04ed47ac7c8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-495-01TYLENOLRegular Strength100 in 1 BOTTLETABLET1007
50580-495-01TYLENOLRegular Strength1 in 1 CARTONTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-495-01EA - Each50580-4959265db0b-2bac-45b9-bd3d-62f1fb1afa1612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-495TYLENOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241109_de5c6654-56c5-40d3-a286-f04ed47ac7c8.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 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediacare Childrens Acetaminophen GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH596372c7-eca3-4527-8e22-ab0751e2526b2024-12-30WarningsExact identifier
application number: M013
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNde5c6654-56c5-40d3-a286-f04ed47ac7c87
209387Tylenol Regular Strength 325 MG Oral TabletPSNde5c6654-56c5-40d3-a286-f04ed47ac7c87
209387acetaminophen 325 MG Oral Tablet [Tylenol]SBDde5c6654-56c5-40d3-a286-f04ed47ac7c87
313782acetaminophen 325 MG Oral TabletSCDde5c6654-56c5-40d3-a286-f04ed47ac7c87
313782APAP 325 MG Oral TabletSYde5c6654-56c5-40d3-a286-f04ed47ac7c87
209387APAP 325 MG Oral Tablet [Tylenol]SYde5c6654-56c5-40d3-a286-f04ed47ac7c87
209387Tylenol 325 MG Oral TabletSYde5c6654-56c5-40d3-a286-f04ed47ac7c87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-495-01505800495011 BOTTLE in 1 CARTON (50580-495-01) / 100 TABLET in 1 BOTTLE1 bottle2019-12-010000-00-00NoNoCurrent