Acetaminophen

Product NDC
0904-6773
11-digit product format
009046773
Labeler code
0904
Product ID
0904-6773_59577dfb-4245-4b66-e063-6294a90a2e8c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-23
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
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
780aad35-d0f1-44b1-e053-2991aa0af9a7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6773-61Acetaminophen10 in 1 BOX, UNIT-DOSETABLET104
0904-6773-61Acetaminophen10 in 1 BLISTER PACKTABLET104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6773-61EA - Each0904-6773eeb743d0-c240-4234-83f6-e86f395e6e6412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6773ACETAMINOPHEN TABLET [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20240214_780aad35-d0f1-44b1-e053-2991aa0af9a7.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 13 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa, Inc.091dd1e7-2484-cdbf-e063-6394a90a21892026-05-11WarningsExact identifier
application number: M013
Little Remedies Infant Fever/Pain RelieverACETAMINOPHENMedtech Products Inc.af5c3b3b-079f-4ee6-a9a4-a13ee8cd99a52026-05-11WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWal-Mart Stores Inc093e0458-9975-456f-8950-8273c8890b3c2026-05-11WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYafacdc0b-fb65-464e-91b8-e82ba7ecde442026-05-11WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEVER and FEVER REDUCER CHERRYACETAMINOPHENDeMoulas Market Basket192f7c24-a4aa-4c05-8d64-5e7e0bf7a1012026-05-09WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEVER and FEVER REDUCER GRAPEACETAMINOPHENDeMoulas Market Basket0ff5c86e-d84b-42ad-b749-636ab2e3734e2026-05-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINRugby Laboratories939fce7e-55df-4dc5-916b-a533448e962f2026-05-08WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.f7e6e984-f0c3-ed40-e053-6294a90a89f72026-05-08WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.c59cbf0e-1381-4dd2-e053-2a95a90a853a2026-05-08WarningsExact identifier
application number: M013
Genexa Acetaminophen Extra StrengthACETAMINOPHENGenexa Inc.d6f968ca-719f-5a68-e053-2995a90a4afa2026-05-08WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.a7bd0b92-6f85-6175-e053-2995a90ab8372026-05-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBryant Ranch Prepack816b65d7-e53f-44c4-a418-074279d4b2af2026-05-08WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerisource Bergen566dbd02-5e04-4461-8f5f-9fb58a42a3752026-05-07WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEDOLGENCORP, LLCd4c0c81b-9176-47d0-a5e4-a584406078d92026-05-07WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENPinnacle RX LLC513cf0e1-6874-9402-e063-6294a90aedc62026-05-07WarningsExact identifier
application number: M013
Infants Pain and Fever Cherry FlavorACETAMINOPHENGenexa Inc.19215ea7-d55f-8d81-e063-6294a90a49242026-05-07WarningsExact identifier
application number: M013
up and up acetaminophen infantsACETAMINOPHENTarget Corporationc1dd8330-fb6b-4d1f-9484-c199dc69214d2026-05-07WarningsExact identifier
application number: M013
Extra Strength AspirinASPIRINHHH Pharmaceuticals90d457bb-79a7-4759-8ee7-6abffbe1e5492026-05-06WarningsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINHHH Pharmaceuticalsd81aec73-c7c1-4c52-80f6-fb0e32caf7aa2026-05-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNee50c5ee-1a61-4efc-aca9-42d897d6a3b88
313782acetaminophen 325 MG Oral TabletSCDee50c5ee-1a61-4efc-aca9-42d897d6a3b88
313782APAP 325 MG Oral TabletSYee50c5ee-1a61-4efc-aca9-42d897d6a3b88
313782acetaminophen 325 MG Oral TabletPSN780aad35-d0f1-44b1-e053-2991aa0af9a74
313782acetaminophen 325 MG Oral TabletSCD780aad35-d0f1-44b1-e053-2991aa0af9a74
313782APAP 325 MG Oral TabletSY780aad35-d0f1-44b1-e053-2991aa0af9a74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6773-610090467736110 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-6773-61) / 10 TABLET in 1 BLISTER PACK10 blister pack2018-10-230000-00-00NoNoCurrent