FDA.reportPublic FDA data

Acetaminophen

Product NDC
69848-003
11-digit product format
698480003
Labeler code
69848
Product ID
69848-003_468e5f4e-8bc6-6b97-e063-6294a90a0166
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Granules USA, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage69848-003-10
excluded packagepackage69848-003-24
excluded packagepackage69848-003-17

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
a1255f60-b9c6-9a95-e053-2995a90a9e80Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69848-003-102020-12-30EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-172020-12-30EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-242020-12-30EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-102020-09-27EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-172020-09-27EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-242020-09-27EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-102020-09-25EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-172020-09-25EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-242020-09-25EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-102020-07-22EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-172020-07-22EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-242020-07-22EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69848-003-10Acetaminophen100 in 1 BOTTLETABLET1008
69848-003-17Acetaminophen175 in 1 BOTTLETABLET1758
69848-003-24Acetaminophen24 in 1 BOTTLETABLET248

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69848-003ACETAMINOPHEN TABLET [GRANULES USA, INC]7Current NDC, Legacy NDC, 3 package rows20241218_a1255f60-b9c6-9a95-e053-2995a90a9e80.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 71 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dye Free Infants Pain and FeverACETAMINOPHENWALGREENS0b1d88d8-56ff-9e9d-e063-6394a90a015c2024-04-09WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEH E B4d572228-3141-4539-9c3d-2fd06e94eee32024-04-09WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC1b5ff867-5442-4cf8-bd1e-530093cc88f82024-04-05WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC0faa3592-4d56-4645-9a0e-066e0bdfebb62024-04-05WarningsExact identifier
application number: M013
Pain Relief Childrens Dye FreeACETAMINOPHENH E B3f9beeeb-5e27-4b81-a647-20e65f0e9fc92024-04-03WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINH E Bedb321dd-e5cb-4031-a8a8-efce9e86fe162024-04-03WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENH E Ba0c0277e-50aa-4328-8f93-ab20c6176b2b2024-04-03WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINBryant Ranch Prepackbda805ab-7f37-405d-a144-4e06ad9a29a12024-04-03WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEFamily Dollar (FAMILY WELLNESS)650cb15e-c448-4df3-b0f8-4398be05d8412024-03-27WarningsExact identifier
application number: M013
Good Sense Effervescent Pain ReliefASPIRINPerrigo Direct, Inc.103027a7-2f0e-8d8c-e063-6294a90aedc72024-03-26WarningsExact identifier
application number: M013
rugby infants acetaminophenACETAMINOPHENRugby Laboratories8aa9ac68-ca61-4163-a876-52034138c1ea2024-03-25WarningsExact identifier
application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mgACETAMINOPHENWalmart Inc08a18481-f029-f01f-e063-6294a90aac652024-03-21WarningsExact identifier
application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mgACETAMINOPHENWalmart Inc0d106fa2-2a77-deb2-e063-6394a90a2dac2024-03-21WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)872c5220-a379-4dc1-b99c-f11ebb82db352024-03-19WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)79886972-47a4-44c5-a131-1a691a3281032024-03-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)5ffcc78d-9163-4cb4-8811-ae9f0142806a2024-03-18WarningsExact identifier
application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERHF Acquisition Co LLC, DBA HealthFirst13e621dc-b2b4-98fd-e063-6394a90acc752024-03-17WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INC097a9c98-a092-400d-9600-6797b0b9a50c2024-03-15WarningsExact identifier
application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC978a9d27-6d41-42cb-a193-11314923d2ac2024-03-14WarningsExact identifier
application number: M013
Excedrin PM Triple Action CapletsACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLCb3812d27-40af-40d7-864a-dfa4ae34cb9e2024-03-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNa1255f60-b9c6-9a95-e053-2995a90a9e808
198440acetaminophen 500 MG Oral TabletSCDa1255f60-b9c6-9a95-e053-2995a90a9e808
198440APAP 500 MG Oral TabletSYa1255f60-b9c6-9a95-e053-2995a90a9e808

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69848-003-1069848000310100 TABLET in 1 BOTTLE (69848-003-10) 100 tablet2019-07-010000-00-00NoNoCurrent
69848-003-1769848000317175 TABLET in 1 BOTTLE (69848-003-17) 175 tablet2019-07-010000-00-00NoNoCurrent
69848-003-246984800032424 TABLET in 1 BOTTLE (69848-003-24) 24 tablet2019-07-010000-00-00NoNoCurrent