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 101 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Menthol Pain Relief Gel-Roll On MENTHOL Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. 0bd62de8-ce8b-c110-e063-6294a90a98cb 2025-02-07 Warnings Exact identifier application number: M017 Menthol Pain Relief Gel-Tube MENTHOL Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. 0bb07892-824e-8691-e063-6294a90a3891 2025-02-07 Warnings Exact identifier application number: M017 Olu Pain Management LIDOCAINE AND CAMPHOR Olakino Therapeutics LLC 2a41a621-c6f7-5819-e063-6394a90ae67d 2025-02-07 Warnings Exact identifier application number: M017 Pain Reliveing Patch LIDOCAINE 4% simple diagnostics 02ed0b27-bba9-ec0c-e063-6294a90a014d 2025-02-07 Warnings Exact identifier application number: M017 FlexDermal Pain Relieving Roll-On MENTHOL SOLVADERM LLC d4d8050e-0761-4491-8635-39c806701eb5 2025-02-06 Warnings Exact identifier application number: M017 Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine LIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE Clarion Brands LLC 2d7e9f6a-0f21-b103-e063-6294a90a912f 2025-02-06 Warnings Exact identifier application number: M017 signature care Hydrocortisone HYDROCORTISONE Safeway 9fe16fc5-77e3-47f5-a943-85bc6565c0d4 2025-02-06 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE PHARMACURE LLC 8803ae01-ea48-46c2-ab64-bb273de605ac 2025-02-05 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate TROLAMINE SALICYLATE TELEBRANDS CORP 2d685602-5cd6-3b36-e063-6394a90a3c5d 2025-02-05 Warnings Exact identifier application number: M017 Lidocore LIDOCAINE iON Pharma, LLC 204c3e50-1ac8-f442-e063-6294a90ae7b5 2025-02-05 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE PHARMACURE LLC 2c32cfed-2022-4e7c-ae9c-ba22dbb560af 2025-02-04 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN PHARMACURE LLC b2b2de93-d957-43d7-a2a8-b46bcaea1f0d 2025-02-04 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream Extreme MENTHOL 16%, CAMPHOR 11% Telebrands Corp 2d54077e-4c8d-aaae-e063-6394a90adb41 2025-02-04 Warnings Exact identifier application number: M017 Capsaicin External Analgesic CAPSAICIN NuCare Pharmaceuticals,Inc. fd90a67d-d60d-a849-e053-6394a90a2cc8 2025-02-04 Warnings Exact identifier application number: M017 Rugby Muscle Rub Cream MUSCLE RUB CREAM NuCare Pharmaceuticals, Inc. 2d58c15a-5ddb-1b16-e063-6294a90a3fbb 2025-02-04 Warnings Exact identifier application number: M017 Cetilar MENTHOL 1.4% PharmaNutra Usa Corp. 2dd14bd4-b4e1-bc7d-e063-6394a90a1e59 2025-02-04 Warnings Exact identifier application number: M017 Stopain Extra Strength Continuous MENTHOL Troy Manufacturing, Inc. 0d199d39-5b47-4c7f-b83a-757f39aa17b6 2025-02-03 Warnings Exact identifier application number: M017 TheraCare Pain Relieving Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 2d42192b-8889-a896-e063-6294a90a4fc8 2025-02-03 Warnings Exact identifier application number: M017 Tiger Balm Pain Relieving Muscle METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) Haw Par Healthcare Ltd. 96b06d3f-8685-4314-ad7d-5d2720f4dde6 2025-02-03 Warnings Exact identifier application number: M017 Icy Hot Medicated No Mess Applicator MENTHOL Chattem, Inc. 4ce2b823-7ef5-4cca-a2d8-2fe781bc958e 2025-02-01 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