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 32 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HQLSEY QUIT SMOKING PATCHES QUIT SMOKING PATCHES Hansen Pharmaceutical Investment Co., Limited 4ba317fb-714a-05cb-e063-6394a90a382f 2026-02-25 Warnings Exact identifier application number: M017 Advanced Pain Relief Cream With 5 % Natural Menthol MENTHOL Allure Labs 4bab9c43-86d4-dad2-e063-6394a90ac095 2026-02-25 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Patch MENTHOL, CAMPHOR, METHYL SALICYLATE Walgreen Co. 4223c74a-12fb-51a3-e063-6294a90a0deb 2026-02-25 Warnings Exact identifier application number: M017 Advanced Pain Relief Roll-On Gel With 5% Natural Menthol MENTHOL Allure Labs 4bad597f-acb2-a122-e063-6394a90a9fcf 2026-02-25 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy LIDOCAINE InterMed Laboratories Private Limited 4bade8a9-43bd-b649-e063-6294a90a81da 2026-02-25 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Strength MENTHOL EX Healthcare Inc. 4620c41a-2187-00f5-e063-6394a90a613c 2026-02-23 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Sculpt MENTHOL EX Healthcare Inc. 4620d4ca-42e4-eeae-e063-6394a90a5c84 2026-02-23 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Extra Strength MENTHOL EX Healthcare Inc. 4620ca7a-afe6-d063-e063-6394a90ab5db 2026-02-23 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Sportpharm LLC 9578b39e-3df7-4d75-abd7-f1d5524545e5 2026-02-23 Warnings Exact identifier application number: M017 0.5% LIDOCAINE BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. cf723c7b-495d-4bae-942c-561cf28af2d3 2026-02-21 Warnings Exact identifier application number: M017 Swiftalyn Numbing Cream MENTHOL 1% GENUINE INNOVATION LTD 4b2ebff2-2f50-e54b-e063-6294a90aaccb 2026-02-19 Warnings Exact identifier application number: M017 Equate Cold Therapy Pain Relieving MENTHOL Walmart Inc 46a3c9e9-5cd3-4bc4-e063-6394a90a7178 2026-02-19 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL, ZINC ACETATE Meijer, Inc. e11390ec-99a3-4ff1-a3c8-ca909f4f67b5 2026-02-19 Warnings, Adverse reactions Exact identifier application number: M017 Aloe Vera Gel LIDOCAINE HCL, MENTHOL Meijer, Inc. d0cc06c1-c0d5-42f0-82cd-8b704cbe1f46 2026-02-19 Warnings, Adverse reactions Exact identifier application number: M017 MENTHOL, CAMPHOR MENTHOL, CAMPHOR CHEMCO CORPORATION 4b1a0e6f-aa68-421c-e063-6294a90a426e 2026-02-18 Warnings Exact identifier application number: M017 Veiurkiu External Analgesic Cream LIDOCAINE BLOOMWELL GARDENS LLC 40ec5e6f-13dc-de04-e063-6294a90af5d5 2026-02-18 Warnings Exact identifier application number: M017 External Analgesic Cream with Menthol 5% MENTHOL 5% BLOOMWELL GARDENS LLC 402faa27-5305-c73d-e063-6394a90a36f2 2026-02-18 Warnings Exact identifier application number: M017 PAINGEL MENTHOL, METHYL SALICYLATE NACOR BUSINESS GROUP LLC 4b1d55e2-cf83-ffbd-e063-6294a90ad52f 2026-02-18 Warnings Exact identifier application number: M017 Alocane Anti-Itch HYDROCORTISONE 1% Quest Products, LLC 45252043-d41a-3cdd-e063-6394a90aa9e5 2026-02-18 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Medrock Pharmacy LLC 43e00e17-1a48-43db-9589-834568917bbf 2026-02-17 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