Acetaminophen

Product NDC
46122-430
11-digit product format
461220430
Labeler code
46122
Product ID
46122-430_2b3cc668-33ec-4afb-944d-38501b465182
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-24
Substance
ACETAMINOPHEN
Active strength
325 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
Brand name suffix
Regular Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 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
313782Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c280ac64-920c-4d03-9190-03e0196ed5efAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-430-78AcetaminophenRegular Strength100 in 1 BOTTLE, PLASTICTABLET, COATED10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-430-78EA - Each46122-4306877702c-7032-4315-a80f-c682636401dc12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-430ACETAMINOPHEN REGULAR STRENGTH (ACETAMINOPHEN) TABLET, COATED [AMERISOURCE BERGEN]12Current NDC, Legacy NDC, 1 package rows20250326_c280ac64-920c-4d03-9190-03e0196ed5ef.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 64 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc639f4e01-9723-a619-e053-2991aa0a549a2024-08-27WarningsExact identifier
application number: M013
Extra Strength Acetaminohpen Adult Rapid Burst CherryACETAMINOPHENMajor Pharmaceuticals9e7543d9-6249-45b5-b67d-c1b439423b9c2024-08-27WarningsExact identifier
application number: M013
aspirinASPIRINMajor Pharmaceuticals58684138-04d1-44a4-bc52-c5b85d93d7a62024-08-23WarningsExact identifier
application number: M013
Up and Up childrens acetaminophenACETAMINOPHENTarget Corporation9c3ba4dd-f51b-46ce-91b8-8b617c7b78da2024-08-23WarningsExact identifier
application number: M013
CVS Effervescent Pain RelieverASPIRINCVS PHARMACY0761147f-1337-606e-e063-6394a90abd5d2024-08-22WarningsExact identifier
application number: M013
pain relieverACETAMINOPHENWalgreen Company8255900a-2d58-4261-8df7-f283198835702024-08-21WarningsExact identifier
application number: M013
Pain and FeverACETAMINOPHENH E B86a072a9-c3b8-47f7-8598-d66e3d30e7622024-08-21WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENKroger Companyd965eba0-b268-41b2-8e02-5f6d769a44d72024-08-18WarningsExact identifier
application number: M013
equate pain and fever childrensACETAMINOPHENWal-Mart Stores Incea68d735-c677-4280-a3a3-ae3eb5ff74622024-08-17WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENCVS Pharmacyfac408f0-ebb6-4c72-88ee-2ba85867859c2024-08-16WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENBryant Ranch Prepack3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad242024-08-14WarningsExact identifier
application number: M013
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma6ec12573-03d6-40c1-9945-d345b401e0622024-08-12WarningsExact identifier
application number: M013
CareOne Infants AcetaminophenACETAMINOPHENAmerican Sales Companyeacee273-abd7-4ea4-bcaa-7f74abcc9feb2024-08-07WarningsExact identifier
application number: M013
infants pain and feverACETAMINOPHENKroger Company7dbe284a-c0d5-4ac4-8445-611610f3c0fb2024-08-02WarningsExact identifier
application number: M013
Dollar General Effervescent Pain RelieverASPIRINDolgencorp, Inc1deab362-a325-3a00-e063-6294a90a9acd2024-08-01WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA STORE INC.1cd6a3e6-1376-0b7b-e063-6394a90af3d12024-07-30WarningsExact identifier
application number: M013
pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLPublix Super Markets Inc42d271b7-b45f-4497-8de2-4e05b4bebfa92024-07-17WarningsExact identifier
application number: M013
basic care acetaminophen pmACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC64a0084a-e29e-4c1a-8704-13a3e1238f762024-07-17WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWalmart Inc.152c013a-c81c-f8f9-e063-6294a90a9f232024-07-15WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNc280ac64-920c-4d03-9190-03e0196ed5ef13
313782acetaminophen 325 MG Oral TabletSCDc280ac64-920c-4d03-9190-03e0196ed5ef13
313782APAP 325 MG Oral TabletSYc280ac64-920c-4d03-9190-03e0196ed5ef13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-430-7846122043078100 TABLET, COATED in 1 BOTTLE, PLASTIC (46122-430-78) 2015-07-240000-00-00NoNoCurrent