Comfortox Benzocaine

Product NDC
54723-999
11-digit product format
547230999
Labeler code
54723
Product ID
54723-999_c88a218a-fec7-4dd3-a0da-aefd7c806163
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Sambria Pharmaceuticals, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-09-07
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
20 mg/100mg
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54723-999-012025-01-30C16284748780-12cef2736-666f-d83d-e063-dadaa90ab31fComfortox B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54723-999-01Comfortox Benzocaine1500 mg in 1 PACKETCREAM15006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54723-999COMFORTOX BENZOCAINE (BENZOCAINE) CREAM [SAMBRIA PHARMACEUTICALS, INC.]6Legacy NDC, 1 package rows20231202_cfb3cb1f-255f-4319-98bb-c353cc0be00e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
723562benzocaine 20 % Topical CreamPSNcfb3cb1f-255f-4319-98bb-c353cc0be00e6
723562benzocaine 200 MG/ML Topical CreamSCDcfb3cb1f-255f-4319-98bb-c353cc0be00e6
723562benzocaine 20 % Topical CreamSYcfb3cb1f-255f-4319-98bb-c353cc0be00e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54723-999-01547230999011500 mg in 1 PACKET (54723-999-01) 1500 mg2016-09-070000-00-00NoNoCurrent