FDA.reportPublic FDA data

Acetaminophen

Product NDC
71205-165
11-digit product format
712050165
Labeler code
71205
Product ID
71205-165_d52d213f-141d-4f01-87c7-0692e69dbc56
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-12
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Acetaminophen
Listing expiration
2027-12-31

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
9af5ccc8-aac0-4339-a9f6-58fdc9b91c57Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-165-10Acetaminophen10 in 1 BOTTLETABLET106
71205-165-24Acetaminophen24 in 1 BOTTLETABLET246
71205-165-30Acetaminophen30 in 1 BOTTLETABLET306
71205-165-40Acetaminophen40 in 1 BOTTLETABLET406
71205-165-50Acetaminophen50 in 1 BOTTLETABLET506
71205-165-60Acetaminophen60 in 1 BOTTLETABLET606
71205-165-90Acetaminophen90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-165-24EA - Each71205-1657f8a9684-4acf-4ba5-b7da-ba6ea1e6000612025-06-13
71205-165-30EA - Each71205-165402348cf-a05c-48c0-9b00-9d20eccb2d9612019-02-13
71205-165-40EA - Each71205-1650082d262-8577-4eb6-830b-267630407a2f12019-02-13
71205-165-50EA - Each71205-165326b34d9-bf0f-4794-afa3-a3434df35ea212019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-165ACETAMINOPHEN TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 7 package rows20250501_9af5ccc8-aac0-4339-a9f6-58fdc9b91c57.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 TabletPSN9af5ccc8-aac0-4339-a9f6-58fdc9b91c576
198440acetaminophen 500 MG Oral TabletSCD9af5ccc8-aac0-4339-a9f6-58fdc9b91c576
198440APAP 500 MG Oral TabletSY9af5ccc8-aac0-4339-a9f6-58fdc9b91c576

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-165-107120501651010 TABLET in 1 BOTTLE (71205-165-10) 10 tablet2018-12-010000-00-00NoNoCurrent
71205-165-247120501652424 TABLET in 1 BOTTLE (71205-165-24) 24 tablet2025-04-24NoNoCurrent
71205-165-307120501653030 TABLET in 1 BOTTLE (71205-165-30) 30 tablet2018-12-010000-00-00NoNoCurrent
71205-165-407120501654040 TABLET in 1 BOTTLE (71205-165-40) 40 tablet2018-12-010000-00-00NoNoCurrent
71205-165-507120501655050 TABLET in 1 BOTTLE (71205-165-50) 50 tablet2018-12-010000-00-00NoNoCurrent
71205-165-607120501656060 TABLET in 1 BOTTLE (71205-165-60) 60 tablet2018-12-010000-00-00NoNoCurrent
71205-165-907120501659090 TABLET in 1 BOTTLE (71205-165-90) 90 tablet2018-12-010000-00-00NoNoCurrent