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 119 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join First Aid Only Burn LIDOCAINE HYDROCHLORIDE Acme United Corporation 9af39fcd-0a57-26d0-e053-2a95a90a99a0 2024-11-17 Warnings Exact identifier application number: M017 First Aid Only First Aid/Burn LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE Acme United Corporation caa67a05-bdbd-c380-e053-2995a90a0bf1 2024-11-17 Warnings Exact identifier application number: M017 Meijer Pain Lidocaine Plus Relieving Analgesic BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc b7385140-3f63-4cbc-b557-de1d29d1ea36 2024-11-15 Warnings Exact identifier application number: M017 Signature Care Hydrocortisone HYDROCORTISONE Safeway c6b9c4e1-bab8-490d-8c00-c43377ad0857 2024-11-15 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Walgreen Company 1a9b8b4c-3e15-49e6-af91-76ed0dc0829e 2024-11-15 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Patrin Pharma Inc. 91eedf9d-53b8-49d5-af59-25019606a0b2 2024-11-15 Warnings Exact identifier application number: M017 equaline anti itch maximum strength HYDROCORTISONE United Natural Foods, Inc. dba UNFI d1ac686e-62f2-4177-8abc-8c7ca578de1a 2024-11-15 Warnings Exact identifier application number: M017 Meijer Pain Relieving Max Strength with Lavender Essential Oil Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc e688967e-799a-4fc8-a19a-f0012b90e76b 2024-11-15 Warnings Exact identifier application number: M017 basic care hydrocortisone HYDROCORTISONE Amazon.com Services LLC a0d0e82b-03ff-4d43-9be0-0e414ee49970 2024-11-15 Warnings Exact identifier application number: M017 DG health hydrocortisone HYDROCORTISONE Dolgencorp, LLC 40710bae-32bb-47fd-b3dd-31d2c98ee70f 2024-11-15 Warnings Exact identifier application number: M017 Meijer Ultra Strength Pain Relieving Topical Analgesic CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Meijer Distribution, Inc 6319b019-8e17-4de1-b4e0-b402288a97d4 2024-11-15 Warnings Exact identifier application number: M017 Meijer Pain Relieving analgesic CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc 9953be94-5768-448f-83de-f5e53a2972cc 2024-11-15 Warnings Exact identifier application number: M017 careone anti itch HYDROCORTISONE American Sales Company 5f7b1435-ebee-4093-847a-79e8d6641404 2024-11-15 Warnings Exact identifier application number: M017 Tiger Balm METHYL SALICYLATE AND MENTHOL Haw Par Healthcare Ltd. 51293a06-5922-4072-ae14-afaba9c1b58e 2024-11-14 Warnings Exact identifier application number: M017 Tylenol Precise Warming Pain Relieving LIDOCAINE Kenvue Brands LLC 0c60b607-ade9-68f2-e063-6394a90a4025 2024-11-13 Warnings Exact identifier application number: M017 Tylenol Precise Pain Relieving LIDOCAINE Kenvue Brands LLC fc1e0451-8c84-729e-e053-6394a90aaba0 2024-11-13 Warnings Exact identifier application number: M017 Neosporin Plus Pain Relief First Aid Antibiotic/Pain Relieving NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE Kenvue Brands LLC 23222e54-d793-4d79-980e-550e32a95742 2024-11-13 Warnings Exact identifier application number: M017 TopCare Pain Relieving Roll-On Topical Analgesic MENTHOL, UNSPECIFIED FORM Topco Associates LLC 48589893-ca67-471d-88bc-92014295ab9f 2024-11-13 Warnings Exact identifier application number: M017 Benadryl Extra Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Kenvue Brands LLC a1c1b878-d58f-41ff-b7a8-477f28c52667 2024-11-12 Warnings Exact identifier application number: M017 Real Time Pain Relief Maxx Plus Topical Analgesic MENTHOL Real Time Products Inc. fc509a55-594d-4d44-87db-33286e937581 2024-11-12 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