Home NDC 10733-167 Topicale
Product NDC 10733-167
11-digit product format 107330167
Labeler code 10733
Product ID 10733-167_28dd17ff-9097-d336-e063-6394a90a00fd
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route ORAL
Labeler Medical Products Laboratories, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-05
Substance BENZOCAINE
Active strength 180 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 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Topicale
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 180 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1042838 Internal RxNorm lookup 1049213 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10733-167-43 Topicale 43 g in 1 BOTTLE, PUMP GEL 43 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10733-167 TOPICALE (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES, INC.] 3 Current NDC, 1 package rows 20241213_8281700c-10f9-841c-e053-2991aa0a918f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 28 of 41 · 818 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e1db79a4-4a24-4c3f-9ee9-2af3f876ac96 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. d3b6669e-479f-4bc1-b533-5e9a0cc65213 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e42a22ef-1035-4dd0-94b0-43625542d584 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. 3dca05de-cf63-4ca0-88be-473ea637e6b4 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. d6149dfd-f2a5-4bbd-913c-6a95efe5ffd2 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. c6eda1de-4490-4a28-8a31-cbf3e102e74e 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 4261cd90-5087-44a3-bef9-72d33dbf0dfd 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc e70240a8-fa9d-4005-a3a0-5cca6188bf61 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc fda3d254-e103-4be9-9086-51ad022b2b3f 2025-01-09 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental c161da79-9ea5-4c7f-890c-4315129fe5bf 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental f7862ee9-117a-493d-83ee-5aef588a86de 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental 011c6a04-a489-41a5-ad2f-8ec281e07933 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental 45422b0f-f1ac-4bec-851a-c1394bc52fcc 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043c336f-60e3-dc23-e063-6294a90a4b13 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC e67b8def-c728-4952-9b35-874643cbe0f1 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC e628bd9f-99e5-4c71-ba8a-caa6c337de54 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC fef1f48c-e89d-4b75-9ba0-b1b068daf582 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental b18c2bfc-638e-40a7-8ecb-60303aa3f519 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental 64b9ebe6-afbe-4db2-b4bf-14ff5d007ea0 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental f5d37a12-9db1-4f2c-9dd1-72a8361e0e57 2025-01-08 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10733-167-43 10733016743 43 g in 1 BOTTLE, PUMP (10733-167-43) 43 g 2019-03-05 No No Current