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 129 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Itch and Rash Cream HYDROCORTISONE Wildman Business Group 1f95757d-a434-f02a-e063-6294a90a2d12 2024-09-01 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Wildman Business Group 1fd1a4b3-b6fd-0d4c-e063-6394a90a3680 2024-09-01 Warnings Exact identifier application number: M017 Thera Care Cold Hot Medicated Patch MENTHOL Veridian Healthcare b1ce129d-06a1-7755-e053-2995a90abd7d 2024-08-29 Warnings Exact identifier application number: M017 BIOSAVIA External Analgesic Pain Relief CAPSAICIN BIOSAVIA USA, LLC 814aa66b-7719-4a29-a84e-18290367e9c7 2024-08-28 Warnings Exact identifier application number: M017 Careland Plantar Fasciitis Hydrogel Pain Patches LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. 0e2f29c2-2e95-4be0-b7e9-f1761a1321a5 2024-08-21 Warnings Exact identifier application number: M017 Careland Max Strength Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 265b8dd7-64a4-4bc2-a91c-26c761c2090b 2024-08-21 Warnings Exact identifier application number: M017 Real Time Pain Relief Maxx Topical Analgesic MENTHOL REAL TIME PRODUCTS, INC f45eb95a-2813-4124-bdb0-54e078a8237d 2024-08-20 Warnings Exact identifier application number: M017 Theracare Lidocaine Pain relief LIDOCAINE Veridian Healthcare 1d8a3679-637d-94c0-e063-6294a90a9ecf 2024-08-19 Warnings Exact identifier application number: M017 LidoSync LIDOCAINE, MENTHOL iON Pharma, LLC 200f883c-439a-3b99-e063-6394a90aed10 2024-08-19 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil Refresh CAMPHOR, MENTHOL Borden Company (Private) Limited 09243a23-1f17-f77b-e063-6394a90a0b22 2024-08-19 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Scalp Relief Anti-itch HYDROCORTISONE CVS Health b5ef0005-8b76-4205-8be0-db3a7ed7d1c4 2024-08-19 Warnings Exact identifier application number: M017 Rite Aid Pain Relieving Roll-On LIDOCAINE HCL Rite Aid Corporation 1406590c-667c-84eb-e063-6294a90a5052 2024-08-16 Warnings Exact identifier application number: M017 Nuvira CAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10% Strand Health Group ff448183-03cf-df2d-e053-6394a90a77f0 2024-08-16 Warnings Exact identifier application number: M017 FLANAX METHYL SALICYLATE, MENTHOL, CAPSAICIN Belmora LLC 5e06c688-a086-4c1c-8dab-fcead61fef40 2024-08-13 Warnings Exact identifier application number: M017 Pain Relief MENTHOL Pain Relieving Spray Inc. 1f44466f-044f-70fe-e063-6294a90ad575 2024-08-09 Warnings Exact identifier application number: M017 Meijer Cold Therapy Pain Relieving MENTHOL Meijer Inc 1c5b55e3-f859-71b6-e063-6294a90a633b 2024-08-08 Warnings Exact identifier application number: M017 HealthWise Soothing Cold Therapy Gel MENTHOL 4% Veridian Healthcare 1f09ccdd-09d8-6a8d-e063-6394a90a184f 2024-08-08 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. fbbbcc67-b46d-d41a-e053-6294a90aa55d 2024-08-08 Warnings Exact identifier application number: M017 Cheezheng Pain Relief Cream MENTHOL Tibet Cheezheng Tibetan Medicine Co. Ltd 37279a3f-9207-4e4c-90d6-52735044f104 2024-08-07 Warnings Exact identifier application number: M017 CVS Health Hydrocortisone Anti Itch HYDROCORTISONE CVS Health 546a1b8a-8254-432a-85c4-38ebee5ad568 2024-08-07 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