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
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
Acetaminophen
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
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 1 of 84 · 1,663 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporation7f445de3-30cf-4bd8-892d-05979cd399e72026-09-09WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINStrategic Sourcing Services LLC7ce4807e-7bd5-41f1-a9c7-1f3af6acdc092026-09-09WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENDOLGENCORP, LLCc637b39c-a049-43af-a582-fc242e940d852026-09-08WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyf7667529-09c0-4603-8080-f236144fac362026-09-08WarningsExact identifier
application number: M013
UP AND UP CHILDRENS ACETAMINOPHENACETAMINOPHENTarget Corporatione2989ead-7fdc-4295-bf94-4231957756702026-09-08WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENRite Aid Corporationd846065a-5c39-4f4b-894c-4280acaaf4fa2026-09-08WarningsExact identifier
application number: M013
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsExact identifier
application number: M013
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsExact identifier
application number: M013
MejoralitoACETAMINOPHENOPMX5a963a92-e29d-05ba-e063-6394a90a3a472026-09-03WarningsExact identifier
application number: M013
PentrexcilinaACETAMINOPHENOPMX LLC5a98e123-8e28-6732-e063-6394a90a010c2026-09-03WarningsExact identifier
application number: M013
infants pain and feverACETAMINOPHENCVS Pharmacy53b06c48-598e-41ad-ac7a-5508c195535c2026-09-03WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINCardinal Health 110, LLC. DBA Leader2777beea-06d7-4ff5-ae4a-ad7a117dfb622026-09-02WarningsExact identifier
application number: M013
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113d92bf-f6c9-cc3d-e063-6294a90af0332026-09-02WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp.78052120-40d8-4a3f-b72f-cc78ca76213b2026-09-02WarningsExact identifier
application number: M013
Adult Low Dose Chewable AspirinASPIRINFarmacias De Similares TX LLC513ea306-74c6-96e3-e063-6394a90a82622026-09-01WarningsExact identifier
application number: M013
Kroger Children Pain plus Fever chewablesACETAMINOPHENKROGER COMPANY83b5733c-70a1-4383-9729-2eb896d0149a2026-09-01WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)923b443d-73cc-4c52-92e4-a075786b1ae32026-09-01WarningsExact identifier
application number: M013
ACETAMINOPHEN PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC99a137d6-07eb-43bc-b4b4-1a23041d595e2026-08-31WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACY64a1ebe7-af28-4b09-96e8-28fa4dcc52bd2026-08-31WarningsExact 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