Gumnumb Topical Anesthetic

Product NDC
24794-221
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.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct24794-221IInactivated by FDA2026-07-31
excluded packagepackage24794-22124794-221-30IInactivated by FDA2026-07-31

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inc.689349e4-3980-a0e4-e053-2991aa0a9ef52018-03-29WarningsExact identifier
ENT Essentials Ear Wax RemvoerCARBAMIDE PEROXIDEWisconsin Pharmacal Company5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b12017-11-08WarningsExact identifier
Dental ReliefBENZOCAINECintas First Aid & Safetyd9068a54-6123-4715-b025-a5bdb4d5c7022014-02-27WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings When using this product do not use longer than four weeks unless recommended by a dentist

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#

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