Topex

Product NDC: 0699-7001
Requested package NDC: 0699-7001-34
11-digit product format: 006997001
Labeler code: 0699
Product ID: 0699-7001_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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0699-7001	0699-7001-34	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
NDC	Effective	Action	Document	Indexing SPL	Related label
0699-7001-34	2020-08-19	C162847	48780-1	ab0e2407-2ba8-f274-e053-dbdaa90a6471	Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7001-34	2020-07-22	C162847	48780-1	ab0e2407-2ba8-f274-e053-dbdaa90a6471	Topex ® Topical Anesthetic Gel 20% Benzocaine

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	TOPEX (BENZOCAINE) GEL, DENTIFRICE [DSHEALTHCARE]	1
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	TOPEX (BENZOCAINE) GEL, DENTIFRICE [DSHEALTHCARE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0699-7001	TOPEX 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"]	10	Legacy NDC	20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0699-7001-34	00699700134	34 g in 1 JAR (0699-7001-34)	34 g	1963-02-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topex ® Topical Anesthetic Gel 20% Benzocaine	Dentsply LLC. Professional Division Trading as "Sultan Healthcare" \| Dentsply Caulk	2025-03-05	HUMAN PRESCRIPTION DRUG LABEL	10