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 68 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81mgASPIRIN 81MGLodaat LLC6a35f38c-a240-4f8c-9a8e-8d283b67b55b2024-06-04WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN 81MGLodaat LLC1ec12f4b-de05-4990-a7b7-f82d867361de2024-06-04WarningsExact identifier
application number: M013
CareOne Infants AcetaminophenACETAMINOPHENAmerican Sales Company0a28a4f1-d947-489b-be28-36ba10b581cf2024-06-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBryant Ranch Prepack77fb237f-28b5-486b-b9ef-cb324d5cc0bd2024-05-30WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBryant Ranch Prepackb5053cf5-209d-4106-afc2-cf9af85f4a692024-05-29WarningsExact identifier
application number: M013
topcare infants pain and feverACETAMINOPHENTopco Associates LLCf129bc0e-1ef1-42a8-8668-2ee88ffc85e32024-05-23WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Childrens Pain and FeverACETAMINOPHENAmerisource Bergen074fdf65-f6ce-46d4-87cc-46911c01cca52024-05-23WarningsExact identifier
application number: M013
DG Health Childrens Pain and FeverACETAMINOPHENDolgencorp, LLC779cf607-245f-408a-81e8-8000c0ea4c4a2024-05-22WarningsExact identifier
application number: M013
good sense pain and fever infantsACETAMINOPHENL. Perrigo Company7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb42024-05-21WarningsExact identifier
application number: M013
Extra Strength Night Time Pain MedicineACETAMINOPHEN, DIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corp2b8f83ed-1ca9-49ac-9b2a-2609b68200f92024-05-21WarningsExact identifier
application number: M013
Acetaminophen SolutionACETAMINOPHENPatrin Pharma, Inc.52ae729b-2255-420c-8db8-cabdc2b747962024-05-21WarningsExact identifier
application number: M013
Ibuprofen, Lil Drug StoreIBUPROFENLil' Drug Store products, Inc.18e80dab-6837-fd2d-e063-6294a90a73c82024-05-20WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)2f9da3d6-229d-44d1-bd94-4bcddbbdb1202024-05-20WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS07d34e7a-c0c6-f3c4-e063-6294a90aa5c32024-05-18WarningsExact identifier
application number: M013
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC10ee2f40-858d-bed4-e063-6394a90a86bb2024-05-17WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTHACETAMINOPHENA-S Medication Solutionsbcb7eb24-16cb-439e-879f-48d2f5e8ba832024-05-17WarningsExact identifier
application number: M013
Basic Care Childrens Pain and FeverACETAMINOPHENAmazon.com Services LLC26266777-185d-4110-a8a7-56846aab25422024-05-17WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTHACETAMINOPHENA-S Medication Solutions1b4db77f-b254-4db5-8e98-d46850140a9b2024-05-16WarningsExact identifier
application number: M013
KOSHER MEDS Childrens Pain and FeverACETAMINOPHENMollec Inc4d01c9ee-26be-4cdd-b52d-7fa344c1933a2024-05-15WarningsExact identifier
application number: M013
Kosher Meds Childrens Allergy ReliefDIPHENHYDRAMINE HCLMollec Inc42ad618b-d2e5-4c58-9407-386df4fe40042024-05-15WarningsExact 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