Benzocaine

Brands: Advance Topical Anesthetic Gel · Alpha-Caine Topical Anesthetic · Anadent Kanka Gel · Astra-Dent Topical Anesthetic Gel +32 · Benzocaine

30 ACTIVE SUPPLIERS - US

openFDA · updated weekly

US233 NDCs
30 active makers

UKComing
soon

CAComing
soon

AUComing
soon

EUComing
soon

ATCC05AD03

RxCUI (US)1399

US makers30 labelers

Packages245

DEA / ScheduleNone

Medicaid dispensing volume

No Medicaid utilization on record for this drug concept yet. Quarterly volume (CMS State Drug Utilization Data) loads with the utilization ETL.

Who makes it30 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

Labeler	Type	Packages	Status
Beutlich Pharmaceuticals, LLC	unknown	23	SUPPLYING
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	unknown	17	SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

Aug 3, 2026
ENTRYNew US registration: benzocaine — Top Quality Manufacturing, Inc. (NDC 69301-059)
Aug 3, 2026
ENTRYNew US registration: benzocaine — Top Quality Manufacturing, Inc. (NDC 69301-058)
Aug 3, 2026
ENTRYNew US registration: benzocaine — Top Quality Manufacturing, Inc. (NDC 69301-061)
Aug 3, 2026
ENTRYNew US registration: benzocaine — Top Quality Manufacturing, Inc. (NDC 69301-057)
Aug 3, 2026
ENTRYNew US registration: benzocaine — Top Quality Manufacturing, Inc. (NDC 69301-056)
Aug 3, 2026
ENTRYNew US registration: benzocaine — Top Quality Manufacturing, Inc. (NDC 69301-060)
May 21, 2026
RECALLRecall (Class II): Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Y…
Defective container:may contain bottles with incomplete seals — Recalling firm: Keystone Industries — Nationwide in the USA
May 21, 2026
RECALLRecall (Class II): safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: S…
Defective container:may contain bottles with incomplete seals — Recalling firm: Keystone Industries — Nationwide in the USA
May 21, 2026
RECALLRecall (Class II): Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pear…
Defective container:may contain bottles with incomplete seals — Recalling firm: Keystone Industries — Nationwide in the USA
May 21, 2026
RECALLRecall (Class II): Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Sup…
Defective container:may contain bottles with incomplete seals — Recalling firm: Keystone Industries — Nationwide in the USA
May 21, 2026
RECALLRecall (Class II): Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dent…
Defective container:may contain bottles with incomplete seals — Recalling firm: Keystone Industries — Nationwide in the USA
May 21, 2026
RECALLRecall (Class II): PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Ma…
Defective container:may contain bottles with incomplete seals — Recalling firm: Keystone Industries — Nationwide in the USA
May 21, 2026
RECALLRecall (Class II): DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental…
Defective container:may contain bottles with incomplete seals — Recalling firm: Keystone Industries — Nationwide in the USA
Nov 14, 2024
RECALLRecall (Class II): safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Glu…
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. — Recalling firm: Keystone Industries — Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Nov 14, 2024
RECALLRecall (Class II): Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patte…
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. — Recalling firm: Keystone Industries — Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Nov 14, 2024
RECALLRecall (Class II): Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Dem…
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. — Recalling firm: Keystone Industries — Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Nov 14, 2024
RECALLRecall (Class II): Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. — Recalling firm: Keystone Industries — Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.