FDA.reportPublic FDA data

Acetaminophen

Product NDC
54738-548
Requested package NDC
54738-548-01
11-digit product format
547380548
Labeler code
54738
Product ID
54738-548_5cc3aaa6-e192-a116-e053-2991aa0a1422
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Richmond Pharmaceuticals, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-05-01
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2026-12-31

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
cda8e158-01ac-4c08-826e-4a0c7278e805Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-548-01Acetaminophen100 in 1 BOTTLETABLET1002
54738-548-03Acetaminophen1000 in 1 BOTTLETABLET10002
54738-548-50Acetaminophen50 in 1 BOTTLETABLET502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-548-01EA - Each54738-548984aae7b-5661-4036-a82a-b6011769141612017-11-06
54738-548-03EA - Each54738-548fe37789b-7d64-4080-b66e-9cb7d6407e3a12017-11-06
54738-548-50EA - Each54738-5482319074e-d642-4008-b9ac-7d58b14180e612017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-548ACETAMINOPHEN TABLET [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20171030_cda8e158-01ac-4c08-826e-4a0c7278e805.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENRichmond Pharmaceuticals, Inc.cda8e158-01ac-4c08-826e-4a0c7278e8052017-10-30WarningsExact identifier
ndc (package): 54738-548-01
ndc (product): 54738-548
ndc11 (package): 54738054801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNcda8e158-01ac-4c08-826e-4a0c7278e8052
313782acetaminophen 325 MG Oral TabletSCDcda8e158-01ac-4c08-826e-4a0c7278e8052
313782APAP 325 MG Oral TabletSYcda8e158-01ac-4c08-826e-4a0c7278e8052
313782acetaminophen 325 MG Oral TabletPSN89134c3e-ec5b-4a57-952a-98d6c6cff7c21
313782acetaminophen 325 MG Oral TabletSCD89134c3e-ec5b-4a57-952a-98d6c6cff7c21
313782APAP 325 MG Oral TabletSY89134c3e-ec5b-4a57-952a-98d6c6cff7c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54738-548-0154738054801100 TABLET in 1 BOTTLE (54738-548-01) 100 tablet2015-05-010000-00-00NoNoCurrent