FDA.reportPublic FDA data

APAP

Product NDC
54738-540
Requested package NDC
54738-540-01
11-digit product format
547380540
Labeler code
54738
Product ID
54738-540_5cc3aaa6-e1aa-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
2015-04-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
APAPACETAMINOPHENRichmond Pharmaceuticals, Inc.ad087586-67cd-4875-b0e6-3fba06ea0f652017-10-30WarningsExact identifier
ndc (package): 54738-540-01
ndc (product): 54738-540
ndc11 (package): 54738054001

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 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
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ad087586-67cd-4875-b0e6-3fba06ea0f65Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-540-01APAP100 in 1 BOTTLETABLET1002
54738-540-03APAP1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-540-01EA - Each54738-5405d17bebf-d9ce-4648-ac1c-3156f3557b6512017-11-06
54738-540-03EA - Each54738-5407f3b9ccd-bcb5-4454-91b1-d48c68cead9d12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-540APAP (ACETAMINOPHEN) TABLET [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20171030_ad087586-67cd-4875-b0e6-3fba06ea0f65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNad087586-67cd-4875-b0e6-3fba06ea0f652
198440acetaminophen 500 MG Oral TabletSCDad087586-67cd-4875-b0e6-3fba06ea0f652
198440APAP 500 MG Oral TabletSYad087586-67cd-4875-b0e6-3fba06ea0f652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54738-540-0154738054001100 TABLET in 1 BOTTLE (54738-540-01) 100 tablet2015-04-010000-00-00NoNoCurrent