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 73 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CVS Cold and Hot MENTHOL CVS Pharmacy a44cec95-822a-40b6-e053-2995a90ae31c 2025-10-17 Warnings Exact identifier application number: M017 Sombra Max SOMBRA MAX Sombra Cosmetics Inc. 41623a46-e6e7-907e-e063-6394a90afc4c 2025-10-17 Warnings Exact identifier application number: M017 POMADA DRAGON PAIN RELIEVING CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE TELEVISA CONSUMER PRODUCTS USA c283291d-feaa-4f89-8fde-9e3957ea8b9f 2025-10-17 Warnings Exact identifier application number: M017 Ear Pain MD LIDOCAINE HYDROCHLORIDE Eosera Inc 78c4418f-7f0f-447f-a94f-d4c89a081af1 2025-10-17 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 414217c1-ff3a-b556-e063-6394a90aa5db 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 41422d04-160b-51b2-e063-6294a90ab2b2 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 41427275-4c35-bbdf-e063-6294a90a14cf 2025-10-16 Warnings Exact identifier application number: M017 Dollar General Menthol Pain Relief Gel Rollon MENTHOL Dolgencorp, LLC 3a9b99e2-36b8-5dcf-e063-6394a90a382d 2025-10-16 Warnings Exact identifier application number: M017 Quality Choice HYDROCORTISONE Chain Drug Marketing Association, Inc. 24c3eb99-92ac-658c-e063-6394a90ab51f 2025-10-16 Warnings Exact identifier application number: M017 DentiCalm TOPICAL ANALGESIC NFUSE LLC 414e6f6f-06bb-b470-e063-6294a90af390 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 413008cd-d239-1453-e063-6394a90a74f2 2025-10-15 Warnings Exact identifier application number: M017 PERFORM LEO EXTENSIVE PAIN RELIEF LIDOCAINE, MENTHOL PERFORM LEO LLC f993ed5f-7dbb-4e3e-addf-f65b12f5cc48 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Lower Leg Sleeve CAPSAICIN Nufabrx LLC b8e3e528-b7cd-e4b7-e053-2995a90a4029 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Ankle Sleeve CAPSAICIN Nufabrx LLC 013d60c7-a613-7cdf-e063-6294a90ad584 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Calf Sleeve CAPSAICIN Nufabrx LLC bd9459c4-5596-746f-e053-2995a90a5400 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Arm Sleeve CAPSAICIN Nufabrx LLC a7993eaf-6488-a818-e053-2995a90a7ea6 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Back Wrap CAPSAICIN Nufabrx LLC e4f85ac8-57cb-46eb-e053-2995a90a9b1c 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Socks CAPSAICIN Nufabrx LLC 013cb66f-8695-b69f-e063-6294a90a699c 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Neck Wrap CAPSAICIN Nufabrx LLC e10b420c-500d-5738-e053-2a95a90a008f 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Knee Sleeve CAPSAICIN Nufabrx LLC a5f455d4-5fc5-d516-e053-2a95a90a921e 2025-10-15 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