FDA.reportPublic FDA data

Gumnumb Topical Anesthetic

Product NDC
24794-221
Requested package NDC
24794-221-30
11-digit product format
247940221
Labeler code
24794
Product ID
24794-221_d618d90d-cd4f-4e4d-e053-2a95a90ad09b
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
Crosstex International Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-07-01
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
200 mg/g
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage24794-22124794-221-30IInactivated by FDA2026-07-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24794-221-302025-01-30C16284748780-12cef2736-91e7-d83d-e063-dadaa90ab31f1b3e24cf-ecb6-4ddd-888a-333895eea66d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24794-221-30Gumnumb Topical Anesthetic30 g in 1 JARGEL305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5GUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5GUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PGUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24794-221GUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.]5Legacy NDC, 1 package rows20220122_1b3e24cf-ecb6-4ddd-888a-333895eea66d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN1b3e24cf-ecb6-4ddd-888a-333895eea66d5
645497GumNumb 20 % Oral GelPSN1b3e24cf-ecb6-4ddd-888a-333895eea66d5
645497benzocaine 0.2 MG/MG Oral Gel [Gum Numb Gel]SBD1b3e24cf-ecb6-4ddd-888a-333895eea66d5
238910benzocaine 0.2 MG/MG Oral GelSCD1b3e24cf-ecb6-4ddd-888a-333895eea66d5
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY1b3e24cf-ecb6-4ddd-888a-333895eea66d5
645497Gum Numb Gel 0.2 MG/MG Oral GelSY1b3e24cf-ecb6-4ddd-888a-333895eea66d5
645497Gumnumb 0.2 MG/MG Oral GelSY1b3e24cf-ecb6-4ddd-888a-333895eea66d5
645497Gumnumb 20 % Oral GelSY1b3e24cf-ecb6-4ddd-888a-333895eea66d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24794-221-302479402213030 g in 1 JAR (24794-221-30) 30 g2018-07-010000-00-00NoNoCurrent