FDA.reportPublic FDA data

Benzodent

Product NDC
71687-1053
11-digit product format
716871053
Labeler code
71687
Product ID
71687-1053_4fe8bad9-af0f-ad56-e063-6394a90a6e12
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Focus Consumer Healthcare, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-08
Substance
BENZOCAINE
Active strength
.2 g/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benzodent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE.2 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui723562, 1112942

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71687-1053-12025-04-14C16284748780-12cef2736-a33e-d83d-e063-dadaa90ab31fBenzodent
71687-1053-22025-04-14C16284748780-12cef2736-a33e-d83d-e063-dadaa90ab31fBenzodent
71687-1053-12025-01-30C16284748780-12cef2736-a33e-d83d-e063-dadaa90ab31fBenzodent
71687-1053-22025-01-30C16284748780-12cef2736-a33e-d83d-e063-dadaa90ab31fBenzodent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71687-1053-1Benzodent7 g in 1 TUBECREAM78
71687-1053-1Benzodent1 in 1 CARTONCREAM18
71687-1053-2Benzodent28 g in 1 TUBECREAM288
71687-1053-2Benzodent1 in 1 CARTONCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71687-1053BENZODENT (BENZOCAINE) CREAM [FOCUS CONSUMER HEALTHCARE, LLC]7Current NDC, Legacy NDC, 4 package rows20250416_5fdcb871-d387-6352-e053-2991aa0a09da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
723562benzocaine 20 % Topical CreamPSN5fdcb871-d387-6352-e053-2991aa0a09da8
1112942Benzodent 20 % Topical CreamPSN5fdcb871-d387-6352-e053-2991aa0a09da8
1112942benzocaine 200 MG/ML Topical Cream [Benzodent]SBD5fdcb871-d387-6352-e053-2991aa0a09da8
723562benzocaine 200 MG/ML Topical CreamSCD5fdcb871-d387-6352-e053-2991aa0a09da8
723562benzocaine 20 % Topical CreamSY5fdcb871-d387-6352-e053-2991aa0a09da8
1112942Benzodent 20 % Oromucosal Topical CreamSY5fdcb871-d387-6352-e053-2991aa0a09da8
1112942Benzodent 200 MG/ML Topical CreamSY5fdcb871-d387-6352-e053-2991aa0a09da8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71687-1053-1716871053011 TUBE in 1 CARTON (71687-1053-1) / 7 g in 1 TUBE1 tube2017-12-080000-00-00NoNoCurrent
71687-1053-2716871053021 TUBE in 1 CARTON (71687-1053-2) / 28 g in 1 TUBE1 tube2017-12-080000-00-00NoNoCurrent