FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
71399-1026
11-digit product format
713991026
Labeler code
71399
Product ID
71399-1026_59d1ee76-55a2-f982-e063-6294a90af0a1
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Akron Pharma Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-06
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
ab79fd60-8315-4c63-8045-1b0511ac268fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-1026-1ACETAMINOPHEN100 in 1 BOTTLETABLET1004
71399-1026-2ACETAMINOPHEN1000 in 1 BOTTLETABLET10004
71399-1026-8ACETAMINOPHEN100000 in 1 DRUMTABLET1000004
71399-1026-9ACETAMINOPHEN60000 in 1 DRUMTABLET600004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-1026-1EA - Each71399-1026d294f43e-7258-42a3-b402-1ca9f725758512025-02-10
71399-1026-2EA - Each71399-1026c2702949-aff5-492f-8577-24cc21a5c2b212025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-1026ACETAMINOPHEN TABLET [AKRON PHARMA INC.]1Current NDC, 4 package rows20241210_ab79fd60-8315-4c63-8045-1b0511ac268f.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 83 · 1,657 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 TabletPSNab79fd60-8315-4c63-8045-1b0511ac268f4
198440acetaminophen 500 MG Oral TabletSCDab79fd60-8315-4c63-8045-1b0511ac268f4
198440APAP 500 MG Oral TabletSYab79fd60-8315-4c63-8045-1b0511ac268f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-1026-171399102601100 TABLET in 1 BOTTLE (71399-1026-1) 100 tablet2024-12-06NoNoCurrent
71399-1026-2713991026021000 TABLET in 1 BOTTLE (71399-1026-2) 1000 tablet2024-12-06NoNoCurrent
71399-1026-47139910260424 TABLET in 1 BOTTLE (71399-1026-4) 24 tablet2024-12-06NoNoCurrent
71399-1026-571399102605500 TABLET in 1 BOTTLE (71399-1026-5) 500 tablet2024-12-06NoNoCurrent
71399-1026-67139910260650 TABLET in 1 BOTTLE (71399-1026-6) 50 tablet2024-12-06NoNoCurrent
71399-1026-871399102608100000 TABLET in 1 DRUM (71399-1026-8) 100000 tablet2024-12-06NoNoCurrent
71399-1026-97139910260960000 TABLET in 1 DRUM (71399-1026-9) 60000 tablet2024-12-06NoNoCurrent