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 32 of 41 · 818 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Benzo-Jel BENZOCAINE Henry Schein Inc. 25c99ae3-90f4-4a63-924d-f810b3ba6e60 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. 84e8d5c8-2a35-4179-9a9c-9a4a52c2cae6 2025-01-03 Warnings Exact identifier application number: M022 Prevention Oncology Mouth Rinse GLYCERIN Prevention Health Sciences, Inc. 1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c 2025-01-01 Warnings Exact identifier application number: M022 Prevention Mouth Sore Rinse HYDROGEN PEROXIDE Prevention Health Sciences, Inc. 2eae61e4-1800-5fa6-e063-6394a90a9583 2025-01-01 Warnings Exact identifier application number: M022 Antiseptic Lil Drug Store Products EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL Lil' Drug Store Products, Inc dca36a30-2c9f-4d0b-be88-b45c7046f509 2024-12-31 Warnings Exact identifier application number: M022 Sensodyne Clinical White Intensive Clean POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC f193ec40-032f-42c7-81f1-029ec8989374 2024-12-31 Warnings Exact identifier application number: M022 TeethWhitening Kit TEETHWHITENING KIT Jiangxi Dentalbright Technology Co., Ltd. 29393313-217a-dc3a-e063-6294a90addb1 2024-12-20 Warnings Exact identifier application number: M022 Breezers Cool Berry PECTIN Mondelez Global LLC b31d0078-21d7-4d18-a8d3-7c8d48d6d004 2024-12-20 Warnings Exact identifier application number: M022 Breezers Creamy Strawberry PECTIN Mondelez Global LLC 777fd6db-f129-4489-8312-4b1aca94878e 2024-12-20 Warnings Exact identifier application number: M022 Halls Breezers Sugar Free Cool Berry PECTIN Mondelez Global LLC dd1b4b17-4f73-4052-9589-d5fd6bb059bb 2024-12-20 Warnings Exact identifier application number: M022 Oral Gel Oral Pain Relief BENZOCAINE BENZALKONIUM CHLORIDE Savvy Care and Cosmetics 05ede7e4-5a0a-c942-e063-6294a90a8a24 2024-12-19 Warnings Exact identifier application number: M022 EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint SODIUM BICARBONATE Lotus Brands, Inc. 4a95c8c1-db7c-4791-ac58-3eac216a0126 2024-12-18 Warnings Exact identifier application number: M022 EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon SODIUM BICARBONATE Lotus Brands, Inc. 6703b29d-cdc9-4c74-91c0-fb0c98dd043e 2024-12-18 Warnings Exact identifier application number: M022 Red Cross Oral Pain Relief BENZOCAINE The Mentholatum Company cbd41429-f730-4577-9f06-ef1831cf62e1 2024-12-17 Warnings Exact identifier application number: M022 Red Cross Canker Sore BENZOCAINE The Mentholatum Company 54cfff96-6665-4b36-a15d-10bf6cf3a1f9 2024-12-17 Warnings Exact identifier application number: M022 Benzoin Tincture BENZOIN RESIN 116956644 2981217f-f250-c090-e063-6294a90a85b0 2024-12-17 Warnings Exact identifier application number: M022 Kank-A Mouth Pain BENZOCAINE Blistex Inc. eebc03ba-f849-4e70-a653-834f383b6aa4 2024-12-17 Warnings Exact identifier application number: M022 Topicale BENZOCAINE Medical Products Laboratories, Inc. 8282a4a6-b77c-75fc-e053-2991aa0ad4ac 2024-12-16 Warnings Exact identifier application number: M022 Topicale Xtra BENZOCAINE Medical Products Laboratories,Inc. 9452bff4-8c08-eff9-e053-2a95a90a67ed 2024-12-16 Warnings Exact identifier application number: M022 PHENOL PHENOL CHAIN DRUG MARKETING ASSOCIATION INC. 2379e23a-72fe-4e94-9d7e-9b623c0db174 2024-12-13 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