FDA.reportPublic FDA data

Chewable Acetaminophen

Product NDC
54738-092
Requested package NDC
54738-092-30
11-digit product format
547380092
Labeler code
54738
Product ID
54738-092_5cc5fab2-77b5-05c5-e053-2991aa0a272d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Richmond Pharmaceuticals, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-04-01
Substance
ACETAMINOPHEN
Active strength
80 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
Chewable Acetaminophen
Brand name suffix
Childrens
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN80 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
307696Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a5dd9031-a960-4a98-ab71-05b079183f1aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-092-30Chewable AcetaminophenChildrens30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-092-30EA - Each54738-092fa50d803-21e3-479c-b6fb-28125ad16ed812017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-092CHEWABLE ACETAMINOPHEN CHILDRENS (ACETAMINOPHEN) TABLET, CHEWABLE [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20171030_a5dd9031-a960-4a98-ab71-05b079183f1a.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
Chewable Acetaminophen ChildrensACETAMINOPHENRichmond Pharmaceuticals, Inc.a5dd9031-a960-4a98-ab71-05b079183f1a2017-10-30WarningsExact identifier
ndc (package): 54738-092-30
ndc (product): 54738-092
ndc11 (package): 54738009230

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307696acetaminophen 80 MG Chewable TabletPSNa5dd9031-a960-4a98-ab71-05b079183f1a2
307696acetaminophen 80 MG Chewable TabletSCDa5dd9031-a960-4a98-ab71-05b079183f1a2
307696APAP 80 MG Chewable TabletSYa5dd9031-a960-4a98-ab71-05b079183f1a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54738-092-305473800923030 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (54738-092-30) 2015-04-010000-00-00NoNoCurrent