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 20 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stud 100 Male Genital Desensitizer LIDOCAINE Pound International Corp d075656e-b13f-4a1d-bbb6-501e642698d5 2026-05-12 Warnings Exact identifier application number: M017 CeraVe Developed with Dermatologists Itch Relief Moisturizing PRAMOXINE HYDROCHLORIDE L'Oreal USA Products Inc 13ce57d0-b1c5-4685-ad7d-a562d9d8fc86 2026-05-12 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY CVS Pharmacy db6f518d-3a0e-43f8-8d19-7382d9b7ff1c 2026-05-11 Warnings Exact identifier application number: M017 Cool and Heat MENTHOL AMERISOURCE BERGEN f2bb0e8e-c4cd-0e8c-e053-2995a90a6df7 2026-05-11 Warnings Exact identifier application number: M017 Instaflex Extra Strength Pain Relief Cream MENTHOL, METHYL SALICYLATE Healthy Directions, LLC d058c64d-0e4f-45aa-8f52-804961b562e3 2026-05-11 Warnings Exact identifier application number: M017 BonicaEaseX Hot Capsicum Pain Relieving CAPSICUM Planet (Anhui) Pharmaceutical Co.,Ltd ca6e48af-af6d-4808-a576-0319d2080d38 2026-05-11 Warnings Exact identifier application number: M017 BonicaEaseX Pain Relieving Lidocaine LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 7486fe89-a377-4a37-997d-e3bd16b891a7 2026-05-11 Warnings Exact identifier application number: M017 YYSDMVY NUMBING Cream LIDOCAINE 4% NUMBING CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 5195f5ec-8524-77f5-e063-6294a90abdc2 2026-05-11 Warnings Exact identifier application number: M017 Lightning X Burn Relief Gel LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 515eb4cc-63af-c11d-e063-6294a90a13ca 2026-05-09 Warnings Exact identifier application number: M017 Albertson Lidocaine, Menthol Pain Relief Medicated Patch LIDOCAINE AND MENTHOL Safeway dc647647-90ec-6beb-e053-2a95a90a7982 2026-05-09 Warnings Exact identifier application number: M017 5 Elementum Lidocaine Male Genital Desensitizer LIDOCAINE MALE GENITAL DESENSITIZER MSVENTURESGROUP O 514b1738-886e-a95d-e063-6294a90aa707 2026-05-08 Warnings Exact identifier application number: M017 Kroger Muscle Rub Cream MENTHOL, CAMPHOR, METHYL SALICYLATE Kroger Co. 45c8c79a-b4b4-d4be-e063-6394a90a9251 2026-05-08 Warnings Exact identifier application number: M017 Walmart Equate Aloe Sunburn Relief Cooling LIDOCAINE WAL-MART STORES INC. 51540f6b-596f-bc47-e063-6294a90a46ae 2026-05-08 Warnings Exact identifier application number: M017 Capsaicin 0.035% cream CAPSAICIN Medcore LLC 0236e1e4-c26c-4fff-a83b-143ce26d93bf 2026-05-07 Warnings Exact identifier application number: M017 Lidocaine 4% Cream LIDOCAINE Medcore LLC 111cb421-ba3b-4772-ab60-d31eb4183168 2026-05-07 Warnings Exact identifier application number: M017 Lidocaine 5% Cream LIDOCAINE Medcore LLC 15d02b42-bf8b-486a-a081-f6d17cc11ec7 2026-05-07 Warnings Exact identifier application number: M017 JenGufun LIDOCAINE Pain Relief Gel-Patch LIDOCAINE PAIN RELIEF GEL-PATCH Henan Kangdi Medical Devices Co., Ltd. 51363a41-5dcc-6a3b-e063-6294a90a6c27 2026-05-07 Warnings Exact identifier application number: M017 Lidoxi LIDOCAINE T&T Pharma Holdings LLC 513c517e-c098-02aa-e063-6294a90ac8a4 2026-05-07 Warnings Exact identifier application number: M017 Harris Teeter Hydrocortisone HYDROCORTISONE HARRIS TEETER LLC 4e8199f8-96ec-5342-e063-6294a90afb2d 2026-05-07 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 5114cdba-96a1-c399-e063-6294a90aac12 2026-05-06 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