Home NDC 85477-307 Topicaine Ultra
Product NDC 85477-307
11-digit product format 854770307
Labeler code 85477
Product ID 85477-307_39d5838a-c935-4447-a315-d27d91659444
Type HUMAN OTC DRUG
Nonproprietary name Topicaine Ultra
Dosage form GEL
Route TOPICAL
Labeler Oncora Pharma, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-01
Substance LIDOCAINE HYDROCHLORIDE
Active strength 20 mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Topicaine Ultra
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1011852 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85477-307-85 Topicaine Ultra 85 g in 1 TUBE GEL 85 1
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 41 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Maximum Strength Hydrocortisone Cream with Aloe HYDROCORTISONE CREAM Walgreens e8f69c4b-2570-477e-9c6d-d552d30ac0d0 2026-01-14 Warnings Exact identifier application number: M017 Hydrocortisone COOL RELIEF GEL WITH ALOE Walgreens 1ae2b37d-d5b2-74d2-e063-6294a90a0de0 2026-01-14 Warnings Exact identifier application number: M017 Maximum Strength Cortisone Cream with Aloe HYDROCORTISONE CREAM CVS Pharmacy b95d30b0-6ebd-4989-a6ac-1a42e5d4aba5 2026-01-14 Warnings Exact identifier application number: M017 Maximum Strength Hydrocortisone Cream with Aloe HYDROCORTISONE CREAM Walgreens 61b93226-10ff-43df-b1b6-bcea917a2f48 2026-01-14 Warnings Exact identifier application number: M017 Maximum Strength Hydrocortisone Cream HYDROCORTISONE CREAM Walgreens 2112067c-0fbb-400c-9923-b932946e1a12 2026-01-14 Warnings Exact identifier application number: M017 Maximum Strength Hydrocortisone Cream HYDROCORTISONE CREAM Walgreens a7db0a6f-ceca-4e77-bad7-55c3c74413a7 2026-01-14 Warnings Exact identifier application number: M017 CVS Therapeutic Menthol Gel MENTHOL CVS Pharmacy a02605cd-40d1-4ea1-9828-0695f2d123aa 2026-01-14 Warnings Exact identifier application number: M017 Maximum Strength Cortisone HYDROCORTISONE OINTMENT CVS Pharmacy f25f2e14-4fc9-4c92-880d-e5f9279d4ecd 2026-01-14 Warnings Exact identifier application number: M017 Icy Hot with Lidocaine No-Mess MENTHOL AND LIDOCAINE Chattem, Inc. a2803c07-bf39-4028-9262-5082da25b46e 2026-01-14 Warnings Exact identifier application number: M017 Cortisone 10 Intensive Moisture Creme HYDROCORTISONE Chattem, Inc. 096a9af3-7e7c-4dae-bc22-44061c60d3c9 2026-01-14 Warnings Exact identifier application number: M017 Icy Hot Dry MENTHOL Chattem, Inc. 720a85cc-8e98-43f2-9cc8-5636ae09624f 2026-01-14 Warnings Exact identifier application number: M017 Gold Bond Extra Strength MENTHOL Chattem, Inc. 98ea15e6-972f-44a3-a1e4-abeae538d5a7 2026-01-14 Warnings Exact identifier application number: M017 Timing Pain Savior Fragrant Ginger Patch MENTHOL, METHYL SALICYLATE Timing Pharmaceutical Co., Ltd PABP Branch a0308e0e-1b47-42ab-88ac-b71ff3fa6c47 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 Easy Relief HYDROCORTISONE Chattem, Inc. beb73818-cd88-44ff-8ecd-b02b910b53b7 2026-01-14 Warnings Exact identifier application number: M017 diphenhydramine hcl and zinc acetate DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Padagis Israel Pharmaceuticals Ltd 6d7a7615-9ae7-4c55-8a84-dba746f535d7 2026-01-14 Warnings Exact identifier application number: M017 Timing Pain Savior Cool Herbal Patch MENTHOL, METHYL SALICYLATE Timing Pharmaceutical Co., Ltd PABP Branch 3b260be8-5e2a-4fba-85d6-2e6c64b97076 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 Feminine Itch Relief HYDROCORTISONE Chattem, Inc. c0c0c1fb-43c9-4903-bb3b-f0885619b8cc 2026-01-14 Warnings Exact identifier application number: M017 Icy Hot Pro Pain Relief Cream w/ microbeads MENTHOL, CAMPHOR Chattem, Inc. df5fd485-f583-46b7-a869-16ca2e17185c 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 Ultra Soothing Creme HYDROCORTISONE Chattem, Inc. 4b62615f-e713-42f2-8b9c-9eebf8d1b270 2026-01-14 Warnings Exact identifier application number: M017 Gold Bond Medicated Pain and Itch Relief LIDOCAINE HYDROCHLORIDE Chattem, Inc. 5767362c-83af-494e-a815-a13f2cb093ef 2026-01-14 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85477-307-85 85477030785 85 g in 1 TUBE (85477-307-85) 85 g 2026-03-01 No No Current