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 30 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RICHTOFIT RAPID ACTIVE ARTHRITIS MENTHOL AND CAMPHOR RICHTOFIT LIMITED LIABILITY COMPANY 4b1cdab1-3e50-4ec3-e063-6394a90af75e 2026-03-12 Warnings Exact identifier application number: M017 5Kind DMSO 4 Lidocaine HCl Pain Relieving LIDOCAINE HYDROCHLORIDE, MENTHOL 5KIND TRADING LTD 67d8d045-7fa0-46c2-8072-645d8823903b 2026-03-11 Warnings Exact identifier application number: M017 Rapid Relief PAIN RELIEF PATCH LIDOCAINE 4% RAPID AID VIET NAM COMPANY LIMITED 4ca541b4-7afe-77c5-e063-6294a90ad692 2026-03-10 Warnings Exact identifier application number: M017 Lidocaine Cream, 4% LIDOCAINE IPG PHARMACEUTICALS, INC. 7775bfdd-7eac-4f09-b83f-fc4a16a24558 2026-03-10 Warnings Exact identifier application number: M017 MENTHOL, CAMPHOR MENTHOL, CAMPHOR CHEMCO CORPORATION 4c989283-9a27-e8d2-e063-6294a90a8bfa 2026-03-09 Warnings Exact identifier application number: M017 Prequel Anti-Itch Solution Medicated Calming MEDICATED CALMING LOTION The Center Brands, LLC 419fa45b-992b-676e-e063-6394a90add81 2026-03-09 Warnings Exact identifier application number: M017 Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. 1fda69f7-2bb6-42fc-bcef-677e7b3d7f01 2026-03-09 Warnings Exact identifier application number: M017 Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for knee MENTHOL, LAUROCAPRAM Planet (Anhui) Pharmaceutical Co., Ltd. 7577625c-87eb-4639-aeab-8a2ab97033fd 2026-03-09 Warnings Exact identifier application number: M017 Careland Lidocaine Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 7de99b81-b3b3-49f1-8aa7-2ff42e1b46a4 2026-03-09 Warnings Exact identifier application number: M017 Rapid Relief PAIN RELIEF PATCH LIDOCAINE 4% RAPID AID VIET NAM COMPANY LIMITED 4ca35030-958c-8f62-e063-6294a90a4d63 2026-03-09 Warnings Exact identifier application number: M017 Welmate Lidocaine Pain Relieving Patch LIDOCAINE YYBA Corp cff71b75-fc4e-29ac-e053-2995a90abd50 2026-03-06 Warnings Exact identifier application number: M017 Heal and Rescue Bunion Pain Relief LIDOCAINE HCL, MENTHOL Rooftop Consumer Health, Inc 4c60d4d3-e0a9-6f93-e063-6394a90a16af 2026-03-06 Warnings Exact identifier application number: M017 JUST CBD - PAIN RELIEF MENTHOL, CAMPHOR Just Brands LLC 4c493c0b-c58e-cb56-e063-6394a90a9395 2026-03-05 Warnings Exact identifier application number: M017 Hug a BooBoo Medicated booboo Wipes BENZOCAINE Lights Medical Manufacture Co., Ltd. 509aaafc-2ef7-4205-818c-7ff5b146e159 2026-03-04 Warnings Exact identifier application number: M017 CVS Foot Pain LIDOCAINE HYDROCHLORIDE CVS Pharmacy 4c3350c3-2e3e-093c-e063-6394a90a3475 2026-03-04 Warnings Exact identifier application number: M017 Game On Sport MENTHOL Natural Essentials, Inc 4c3411dc-5378-bd93-e063-6394a90a8406 2026-03-04 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE Trifecta Pharmaceuticals Usa Llc f4d4a56b-b4b7-9a07-e053-2a95a90ad853 2026-03-04 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE Trifecta Pharmaceuticals Usa Llc 9987165c-1a0f-dd57-e053-2a95a90ae735 2026-03-04 Warnings Exact identifier application number: M017 Walgreens Unscented Pain Relieving LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL Walgreen Co. 41eadb4f-2ca5-42a1-e063-6294a90ab4e2 2026-03-04 Warnings Exact identifier application number: M017 Careland Pain Relief Patch Plus LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e3 2026-03-04 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