Pillstats
OTC · Gel · Dental

Benzocaine

Brands: Advance Topical Anesthetic Gel · Alpha-Caine Topical Anesthetic · Anadent Kanka Gel · Astra-Dent Topical Anesthetic Gel +33 · Benzocaine

30 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US227 NDCs
30 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
RxCUI (US)1399
US makers30 labelers
Packages239
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.

LabelerTypePackagesStatus
Beutlich Pharmaceuticals, LLCunknown23SUPPLYING
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.unknown17SUPPLYING
Dharma Research, inc.unknown16SUPPLYING
Benco Dentalunknown12SUPPLYING
Patterson Dentalunknown12SUPPLYING
Pearson Dental Supplies INC.unknown10SUPPLYING
Burkhart Dental Supply Incunknown10SUPPLYING
IQ Dental Supply, LLCunknown9SUPPLYING
ICP Inc DBA Dental Cityunknown9SUPPLYING
Tri State Dentalunknown9SUPPLYING
Zag Usa Incunknown8SUPPLYING
PureLife Dentalunknown8SUPPLYING
Dental Health Products, Inc.unknown8SUPPLYING
Henry Schein Inc.unknown8SUPPLYING
Top Quality Manufacturing, Inc.unknown7SUPPLYING

+ 15 more labelers

Regulatory & supply eventsFDA · US

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

  • 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.