Topex

Product NDC
0699-7021
Requested package NDC
0699-7021-34
11-digit product format
006997021
Labeler code
0699
Product ID
0699-7021_a07891e5-c90e-4a6a-b592-75f696809e71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1963-02-19
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
220 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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0699-70210699-7021-34DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0699-7021-342020-08-19C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7021-342020-07-22C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5TOPEX (BENZOCAINE) GEL, DENTIFRICE [DSHEALTHCARE]1
BenzocaineACTIVE MOIETYU3RSY48JW5TOPEX (BENZOCAINE) GEL, DENTIFRICE [DSHEALTHCARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0699-7021TOPEX PINA COLADA (BENZOCAINE) GEL, DENTIFRICE TOPEX CHERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX MINT (BENZOCAINE) GEL, DENTIFRICE TOPEX BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE TOPEX STRAWBERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX RASPBERRY (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]10Legacy NDC20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0699-7021-340069970213434 g in 1 JAR (0699-7021-34) 34 g1963-02-190000-00-00NoNoCurrent