Top Quality Mfg. Topical Anesthetic

Product NDC
69301-001
11-digit product format
693010001
Labeler code
69301
Product ID
69301-001_2bd92f3c-516b-7dac-e063-6294a90ae719
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
Top Quality Manufacturing, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Top Quality Mfg. Topical Anesthetic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69301-001-30Top Quality Mfg. Topical Anesthetic30 g in 1 JARGEL305

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69301-001TOP QUALITY MFG. TOPICAL ANESTHETIC (BENZOCAINE) GEL [TOP QUALITY MANUFACTURING, INC.]5Current NDC, Legacy NDC, 1 package rows20250119_fbac0cb4-0ccb-4d9d-9deb-a827c7bc8c66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNfbac0cb4-0ccb-4d9d-9deb-a827c7bc8c665
238910benzocaine 0.2 MG/MG Oral GelSCDfbac0cb4-0ccb-4d9d-9deb-a827c7bc8c665
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYfbac0cb4-0ccb-4d9d-9deb-a827c7bc8c665

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69301-001-306930100013030 g in 1 JAR (69301-001-30) 30 g2018-11-010000-00-00NoNoCurrent