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 141 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LEADER Camphor Spirit CAMPHOR (NATURAL) Cardinal Health, 110 dba Leader 7d3b0b28-5190-0622-e053-2991aa0af561 2023-12-22 Warnings Exact identifier application number: M017 Antiseptic Instant Pain Relief CAMPHOR 10.8% AND PHENOL 4.7% Pharma Nobis, LLC e42f484d-a642-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Itch Relief Gel ITCH RELIEF GEL Pharma Nobis, LLC e42f484d-a641-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Witch Hazel WITCH HAZEL Pharma Nobis, LLC e42f484d-a644-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Dermoplast Pain relieving BENZOCAINE, MENTHOL Advantice Health dad00c95-4e11-3eec-e053-2a95a90a7a18 2023-12-21 Warnings Exact identifier application number: M017 equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesic LIDOCAINE HYDROCHLORIDE Wal-Mart Stores, Inc. bf954949-a7b7-44ba-8565-f1d5c0a6c0d1 2023-12-21 Warnings Exact identifier application number: M017 Bactine Max Bandage LIDOCAINE WellSpring Pharmaceutical Corporation 465dc46e-6435-4569-9516-f648d0fe0f09 2023-12-21 Warnings Exact identifier application number: M017 Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC CAMPHOR, MENTHOL, METHYL SALICYLATE LABORATORIOS QUANTIUM LLC c4efa317-8dd1-49e1-b7ca-9df2147edd3e 2023-12-21 Warnings Exact identifier application number: M017 DDM Camphor Spirit CAMPHOR 10% Discount Drug Mart 5d56cbe6-4e48-79eb-e053-2a91aa0a74d3 2023-12-20 Warnings Exact identifier application number: M017 Quality Choice Camphor Spirit CAMPHOR 10% Chain Drug Market Association 8d352a67-2024-43d0-b525-038d398949e6 2023-12-20 Warnings Exact identifier application number: M017 Instant Antiseptic Pain Relief CAMPHOR 10.8% AND PHENOL 4.7% Chain Drug Market Association 2cd60df3-bfde-4747-ba4f-7121612f2e63 2023-12-20 Warnings Exact identifier application number: M017 Poison Ivy Wash PRAMOXINE HCL Chain Drug Market Association 873a546b-90ae-50cb-e053-2a91aa0adbfb 2023-12-20 Warnings Exact identifier application number: M017 Premier Value Instant Antiseptic Pain Relief CAMPHOR 10.8% AND PHENOL 4.7% Pharmacy Value Alliance LLC 9d63f8ed-fc50-0d84-e053-2a95a90a6e92 2023-12-20 Warnings Exact identifier application number: M017 Ear Drops CARBAMIDE PEROXIDE 6.5% CVS Pharmacy 8a872991-01af-5fd0-e053-2995a90ac7f4 2023-12-20 Warnings Exact identifier application number: M017 CVS Cold and Hot Roll-On COOL AND HEAT PAIN RELIEF CVS Pharmacy b8cc578a-be6d-90c0-e053-2995a90a7742 2023-12-20 Warnings Exact identifier application number: M017 Sunmark Camphor Spirit CAMPHOR 10% Strategic Sourcing Services LLC 667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa 2023-12-19 Warnings Exact identifier application number: M017 DDM Instant Antiseptic Pain Relief CAMPHOR 10.8% AND PHENOL 4.7% Discount Drug Mart 5d56c74f-604d-4fed-e053-2a91aa0a417c 2023-12-19 Warnings Exact identifier application number: M017 HEB Camphor Phenol CAMPHOR 10.8% AND PHENOL 4.7% H E B 5d573883-001d-e5a4-e053-2991aa0a6203 2023-12-18 Warnings Exact identifier application number: M017 Petrocort Antipruritic Lip 21 HYDROCORTISONE Clinical Formula LLC 7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b 2023-12-15 Warnings Exact identifier application number: M017 DermaWound Wound Care Venous Stasis BENZOCAINE HYDROCHLORIDE Progressive Doctors, LLC 6221ba86-8b7f-48c8-8284-6950f9fc36b1 2023-12-15 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