Acetaminophen Regular Strength

Product NDC
54257-720
11-digit product format
542570720
Labeler code
54257
Product ID
54257-720_08bf78b4-64d4-cd41-e063-6294a90a96db
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Magno-Humphries, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-24
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 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
9d22d642-8aaf-d17e-e053-2995a90ae182Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54257-720-02Acetaminophen Regular Strength100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-720ACETAMINOPHEN REGULAR STRENGTH (ACETAMINOPHEN) TABLET [MAGNO-HUMPHRIES, INC.]4Current NDC, Legacy NDC, 1 package rows20231030_9d22d642-8aaf-d17e-e053-2995a90ae182.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 63 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby AspirinASPIRINRugby Laboratories15922349-2825-45d3-95ff-c5a2879ec2252024-09-12WarningsExact identifier
application number: M013
rexall pain reliefACETAMINOPHENDolgencorp, LLC9783cf37-3a2b-4ca1-b4eb-6d6ba047a3252024-09-12WarningsExact identifier
application number: M013
leader aspirinASPIRINCardinal Health 110, LLC. dba Leaderb8cc9f78-a292-40eb-819d-bd80a552628f2024-09-11WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENH E B3258ef39-c36e-4a97-8631-89b8d4caf0582024-09-11WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYb9b86755-63ad-e25a-e053-2995a90ad7472024-09-10WarningsExact identifier
application number: M013
aspirinASPIRINPublix Super Markets Inc88b0d897-b93f-42c3-88d0-784dd6c555e42024-09-10WarningsExact identifier
application number: M013
good neighbor pharmacy aspirinASPIRINAmerisource Bergen820ceaee-2b49-4204-8ebb-d683d9b62e142024-09-10WarningsExact identifier
application number: M013
Parents Choice Infants Pain and FeverACETAMINOPHENWal-Mart Stores Inc30a51b90-a565-4e38-82ee-b5af297629772024-09-10WarningsExact identifier
application number: M013
equate aspirin chewableASPIRINWal-Mart Stores Inc9147c0ce-fcdb-457c-b9f5-e4edd66e91d02024-09-10WarningsExact identifier
application number: M013
signature care infants pain reliefACETAMINOPHENSafeway236df05a-cf11-42f3-a347-b54f5113680c2024-09-10WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Incd2759fa6-59cd-417e-8761-d2b129aad8b82024-09-09WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepackd344479b-80c1-4592-acc8-3f12690c839c2024-09-06WarningsExact identifier
application number: M013
signature care childrens pain reliefACETAMINOPHENSafewayfccb5aca-5707-491f-beb4-08f5689191692024-09-06WarningsExact identifier
application number: M013
HEADACHE RELIEFACETAMINOPHEN-ASPIRIN-CAFFEINETARGET CORPORATION8e953cef-135e-f1aa-e053-2995a90aaa8b2024-09-05WarningsExact identifier
application number: M013
AspirinASPIRINCVS Pharmacy5cf74d72-c818-400a-9279-87e209efeb152024-09-05WarningsExact identifier
application number: M013
ASPIRNASPIRINHF Acquisition Co LLC, DBA HealthFirst21524b42-f8fd-673c-e063-6294a90a22e82024-09-04WarningsExact identifier
application number: M013
Topcare AspirinASPIRINTopco Associates LLC6615bf85-1f79-4d21-91f9-4248c3cf9b382024-09-04WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENTARGET CORPORATION80da2582-1a20-e111-e053-2991aa0acf322024-09-03WarningsExact identifier
application number: M013
Good Neighbor Pharmacy AspirinASPIRINAmerisource Bergend9db6659-6afc-431b-ae05-c941775e63662024-09-01WarningsExact identifier
application number: M013
Topcare AspirinASPIRINTopco Associates LLC8133c3fc-97ce-46b4-8580-7da9f09f622b2024-08-30WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN9d22d642-8aaf-d17e-e053-2995a90ae1824
313782acetaminophen 325 MG Oral TabletSCD9d22d642-8aaf-d17e-e053-2995a90ae1824
313782APAP 325 MG Oral TabletSY9d22d642-8aaf-d17e-e053-2995a90ae1824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54257-720-0254257072002100 TABLET in 1 BOTTLE (54257-720-02) 100 tablet2020-01-240000-00-00NoNoCurrent