Topex

Product NDC
0699-3100
11-digit product format
006993100
Labeler code
0699
Product ID
0699-3100_015b2c83-52fd-4360-a252-90674052adaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzocaine
Dosage form
SPRAY, METERED
Route
PERIODONTAL
Labeler
Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1974-01-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0699-3100IInactivated by FDA2026-10-05
excluded packagepackage0699-31000699-3100-02IInactivated by FDA2026-10-05

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0699-3100-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0699-3100-02f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0699-3100-02Topex1 in 1 CARTONSPRAY, METERED16
0699-3100-02Topex57 g in 1 CANISTERSPRAY, METERED576

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0699-3100-02GM - Gram0699-3100fb8f3a18-06d2-45db-a828-e51138583b2a12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0699-3100TOPEX (BENZOCAINE) SPRAY, METERED [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]6Legacy NDC, 2 package rows20240208_60c87af2-1dc5-2daf-e053-2a91aa0a7555.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360348benzocaine 20 % Mucosal SprayPSN60c87af2-1dc5-2daf-e053-2a91aa0a75556
360348benzocaine 200 MG/ML Mucosal SpraySCD60c87af2-1dc5-2daf-e053-2a91aa0a75556
360348benzocaine 20 % Mucosal SpraySY60c87af2-1dc5-2daf-e053-2a91aa0a75556

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0699-3100-02006993100021 CANISTER in 1 CARTON (0699-3100-02) > 57 g in 1 CANISTER1 canister1974-01-010000-00-00NoNoCurrent