ACETAMINOPHEN 325 MG

Product NDC
71205-456
11-digit product format
712050456
Labeler code
71205
Product ID
71205-456_d25dcece-12ac-4e85-a6ec-fd71d1dc1fde
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
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 325 MG
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
6794830a-7856-464d-84be-c8b253cf41acAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-456-00ACETAMINOPHEN 325 MG100 in 1 BOTTLE, PLASTICTABLET1005
71205-456-30ACETAMINOPHEN 325 MG30 in 1 BOTTLE, PLASTICTABLET305
71205-456-60ACETAMINOPHEN 325 MG60 in 1 BOTTLE, PLASTICTABLET605
71205-456-90ACETAMINOPHEN 325 MG90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-456-30EA - Each71205-45653c80524-18b7-4929-810f-ee7fee59cb3612022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-456ACETAMINOPHEN 325 MG (ACETAMINOPHEN) TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20240223_6794830a-7856-464d-84be-c8b253cf41ac.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 54 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.a891896d-c9fa-4448-915a-e6b531157d222024-12-02WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSAFEWAYd2d15e06-e9eb-3d2b-e053-2995a90a1cec2024-12-02WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENTopCo Associates LLCc2d33352-431c-4683-a4fa-a54437e7b8d22024-12-02WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENTopCo Associates LLCbdb01b3e-ad34-4003-9b9a-e83a2c0e90bb2024-12-02WarningsExact identifier
application number: M013
Aspirin 81mg Adult Low DoseASPIRINTopCare14d010fb-c4a1-4c3d-942f-58719727bfc02024-12-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS Pharmacy, Incc4473ee6-4e01-1ec2-e053-2995a90ac5132024-12-02WarningsExact identifier
application number: M013
AspirinASPIRINProficient Rx LP9c186289-e309-45e8-8934-1d0eae0375c22024-12-01WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP22f63d62-c941-5b8f-e063-6394a90aeecd2024-11-28WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a7b6318-b7d6-31b1-e053-2991aa0abf252024-11-28WarningsExact identifier
application number: M013
Extra Strength Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLINGLES MARKETS, INC.27fd288e-c07a-617f-e063-6394a90a17a42024-11-28WarningsExact identifier
application number: M013
BAYER Aspirin Original, TRAVEL BASIXASPIRINLil' Drug Store Products, Inc.7f5d9ebe-8119-49a2-9380-eca18a5e5e852024-11-27WarningsExact identifier
application number: M013
EXCEDRIN MIGRAINEACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINEJones Healthcare Group - Packaging Services, Incc4168e4d-3dfc-4e51-a32e-14704cb59c662024-11-27WarningsExact identifier
application number: M013
TYLENOL Extra Strength / TYLENOL Precise Cooling Pain ReliefACETAMINOPHEN, LIDOCAINE, MENTHOLKenvue Brands LLC2611e984-0dd5-bda1-e063-6394a90a559a2024-11-26WarningsExact identifier
application number: M013
First Aid Only Extra-Strength Non-AspirinACETAMINOPHENAcme United Corporation6891d57a-10a6-53de-e053-2a91aa0ac7c22024-11-26WarningsExact identifier
application number: M013
Chewable AspirinASPIRINMARC GLASSMAN, INC.c8314910-71ff-5a55-e053-2995a90aafc72024-11-26WarningsExact identifier
application number: M013
AspirinASPIRINMarc Glassman, Inc.7990ca49-fb30-40fe-9ac4-48e89eac9bb22024-11-26WarningsExact identifier
application number: M013
Enteric Coated Aspirin Regular StrengthASPIRINSafeway96359eb6-62bc-4b13-960c-050af99a8c022024-11-26WarningsExact identifier
application number: M013
ASPIRIN Low DoseASPIRINMarc Glassman, Inc.3d519af3-9398-4439-8253-1e5d4612b8e32024-11-26WarningsExact identifier
application number: M013
ACETAMINOPHEN (RED)ACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.06eabf4b-f8c0-439a-acf1-aa6e3075c7172024-11-25WarningsExact identifier
application number: M013
ACETAMINOPHEN (RED)ACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltda352f588-4a70-42b2-8f9c-a73a0629517d2024-11-25WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN6794830a-7856-464d-84be-c8b253cf41ac5
313782acetaminophen 325 MG Oral TabletSCD6794830a-7856-464d-84be-c8b253cf41ac5
313782APAP 325 MG Oral TabletSY6794830a-7856-464d-84be-c8b253cf41ac5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-456-0071205045600100 TABLET in 1 BOTTLE, PLASTIC (71205-456-00) 100 tablet2020-06-150000-00-00NoNoCurrent
71205-456-307120504563030 TABLET in 1 BOTTLE, PLASTIC (71205-456-30) 30 tablet2022-02-020000-00-00NoNoCurrent
71205-456-607120504566060 TABLET in 1 BOTTLE, PLASTIC (71205-456-60) 60 tablet2022-02-020000-00-00NoNoCurrent
71205-456-907120504569090 TABLET in 1 BOTTLE, PLASTIC (71205-456-90) 90 tablet2022-02-020000-00-00NoNoCurrent