FDA.reportPublic FDA data

Acetaminophen

Product NDC
69848-008
11-digit product format
698480008
Labeler code
69848
Product ID
69848-008_468e7582-908f-6ec4-e063-6394a90a1653
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
2020-05-01
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproduct69848-008IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69848-00869848-008-10IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…

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
a51395ea-e038-dc9c-e053-2a95a90a287dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-12-30EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free
2020-09-27EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free
2020-09-25EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free
2020-07-22EXTRA STRENGTH Pain Relief Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Rapid Release Aspirin free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69848-008-10Acetaminophen100 in 1 BOTTLETABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69848-008ACETAMINOPHEN TABLET [GRANULES USA, INC]6Current NDC, Legacy NDC, 1 package rows20241218_a51395ea-e038-dc9c-e053-2a95a90a287d.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 61 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chewable AspirinASPIRINRETAIL BUSINESS SERVICES , LLC.c94d68ea-7f25-881f-e053-2995a90aa47f2024-10-15WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINRETAIL BUSINESS SERVICES , LLC.c94d750e-5a85-77f5-e053-2995a90a69152024-10-15WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWalgreen Company9e08eb38-7538-4fa0-a0e1-047ab6cb16802024-10-15WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENPUBLIX SUPER MARKETS INC9e779cc6-4641-6132-e053-2a95a90a34932024-10-11WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENCHAIN DRUG CONSORTIUM5c1a3081-ae25-4895-bf76-ebcbb9fc80722024-10-11WarningsExact identifier
application number: M013
Aspirin 81 MGASPIRINMeijerb3e5711c-9529-4eec-871d-de8efa858b862024-10-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMEIJER DISTRIBUTION INC9586e830-a285-4a07-8b34-9698754423482024-10-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association68a52858-35c5-402a-8ceb-8d8a7c1e5f6c2024-10-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association5de40821-3218-4320-bf11-9493bf01d4892024-10-11WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association475becec-1a56-4cfa-a0c5-562f8772adfb2024-10-11WarningsExact identifier
application number: M013
Topcare Pain ReliefACETAMINOPHENTopco Associates LLC6036c15b-1168-4103-9471-6a74a2140e532024-10-10WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma46d9d8cd-e3db-492c-9386-7e8255beff642024-10-08WarningsExact identifier
application number: M013
dg health aspirinASPIRINDolgencorp, LLC0ab34dc7-0110-4fc3-ae53-234e7d7bca3c2024-10-07WarningsExact identifier
application number: M013
ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.19ba1fb6-22ea-488e-9e52-94c14ceb80d12024-10-07WarningsExact identifier
application number: M013
foster and thrive aspirinASPIRINStrategic Sourcing Services LLC4d66a8a8-a1c1-4430-8845-21ae67700c392024-10-07WarningsExact identifier
application number: M013
leader aspirinASPIRINCardinal Health 110, LLC. dba Leaderca603b12-e0f7-4d79-8e0d-4651a788ba9b2024-10-07WarningsExact identifier
application number: M013
foster and thrive aspirinASPIRINMcKesson Medical-Surgical, Inc.e9342478-93d6-45de-948f-f4162ee675b22024-10-07WarningsExact identifier
application number: M013
Maximum Strength Backache ReliefMAGNESIUM SALICYLATEJHK DBA American Safety & First Aidf8cbcd4e-cfad-4592-8774-52e681494c452024-10-07WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorALKA-SELTZER ORIGINAL FLAVORNavajo Manufacturing Company Inc.f70875ab-241c-4876-e053-6294a90a80922024-10-03WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.86b6ac01-3866-4cd8-a1be-9babb6ff311b2024-10-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNa51395ea-e038-dc9c-e053-2a95a90a287d7
198440acetaminophen 500 MG Oral TabletSCDa51395ea-e038-dc9c-e053-2a95a90a287d7
198440APAP 500 MG Oral TabletSYa51395ea-e038-dc9c-e053-2a95a90a287d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69848-008-1069848000810100 TABLET in 1 BOTTLE (69848-008-10) 100 tablet2020-05-010000-00-00NoNoCurrent