Home NDC 65197-502-04 Solarcaine Burn Pain Relief 4oz
Product NDC 65197-502
Requested package NDC 65197-502-04
11-digit product format 651970502
Labeler code 65197
Product ID 65197-502_c455721a-9bce-42b8-a7ee-ce9d54aea4c5
Type HUMAN OTC DRUG
Nonproprietary name Solarcaine Burn Pain Relief 4oz
Dosage form SPRAY
Route TOPICAL
Labeler WellSpring Pharmaceutical Corporation
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance LIDOCAINE HYDROCHLORIDE
Active strength 4 g/100g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Solarcaine Burn Pain Relief 4oz
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100g
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 1045432 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65197-502-04 Solarcaine Burn Pain Relief 4oz 113 g in 1 CAN SPRAY 113 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-502 SOLARCAINE BURN PAIN RELIEF 4OZ (SOLARCAINE BURN PAIN RELIEF 4OZ) SPRAY [WELLSPRING PHARMACEUTICAL CORPORATION] 2 Current NDC, 1 package rows 20240101_14f23c28-c713-4868-9f46-66363bf94b2c.zip
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 1 of 153 · 3,056 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On MENTHOL Chattem, Inc. aa40c907-eeb5-4fda-b35e-439cbecc178c 2026-07-31 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine Dry LIDOCAINE Chattem, Inc. 008abaaa-5e12-4246-a7f5-66f3966acf28 2026-07-30 Warnings Exact identifier application number: M017 Icy Hot Performance No-Mess Pain Relief Cream MENTHOL 16%, CAMPHOR 11% Chattem, Inc. 5e3e272a-c001-4f57-9535-521ccc85ae65 2026-07-30 Warnings Exact identifier application number: M017 Auixudin Lidocaine Pain Relief Gel-Patch LIDOCAINE PAIN RELIEF GEL-PATCH Henan Enokon Medical Instrument Co., Ltd. 57bc7b9e-e2f7-724b-e063-6394a90ab36f 2026-07-29 Warnings Exact identifier application number: M017 Jinfahe Lidocaine Pain Relief Patch LIDOCAINE PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 57bcd9c5-767e-b634-e063-6394a90a2878 2026-07-29 Warnings Exact identifier application number: M017 Maximun Strength Lidocaine Patch Plus Menthol LIDOCAINE, MENTHOL Meijer Distribution Inc d0468514-58ea-4d8f-b634-a65bf95c0316 2026-07-29 Warnings Exact identifier application number: M017 Oudetas Lidocaine Cream LIDOCAINE CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 57ca9220-2778-790a-e063-6294a90af506 2026-07-29 Warnings Exact identifier application number: M017 Aspercreme Lidocaine No-Mess plus Lavender LIDOCAINE HCL Chattem, Inc. 3948a3d2-ce04-4703-8709-211e75c9c38d 2026-07-29 Warnings Exact identifier application number: M017 LidoPro LIDOCAINE AND MENTHOL Clinic Pharma cdfd6b39-b430-4e95-a0f7-682cf3d78b52 2026-07-28 Warnings Exact identifier application number: M017 LidoPro Patch (Lidocaine 4%, Menthol 1%) LIDOCAINE AND MENTHOL PATCH Clinic Pharma 2b4d2105-b7ad-2695-e063-6394a90a999b 2026-07-28 Warnings Exact identifier application number: M017 Earths Care Pain Relieving CAMPHOR, MENTHOL, METHYL SALICYLATE DLC Laboratories, Inc. 5c3976da-a6cb-4b94-ae41-3e86b1ab13cb 2026-07-28 Warnings Exact identifier application number: M017 Muscle Rub Cream MENTHOL 10%, METHYL SALICYLATE 15% Preferred Pharmaceuticals Inc. 9e7568b6-52ae-4f7a-9bfd-503fd80a297e 2026-07-28 Warnings Exact identifier application number: M017 Aspercreme Lidocaine with Rosemary and Mint LIDOCAINE HYDROCHLORIDE Chattem, Inc. 9d40bfea-85d0-4943-83e9-0c16e79a011c 2026-07-28 Warnings Exact identifier application number: M017 KENS PAIN AND ARTHRITIS FORMULA MENTHOL Eezaway Relief Inc 35834473-3ad5-41ec-a110-e742aa7e2ee4 2026-07-28 Warnings Exact identifier application number: M017 DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM Wenzhou Yuyuan Pharmaceutical Co., Ltd. 57935b64-6e2e-85d0-e063-6394a90a7428 2026-07-27 Warnings Exact identifier application number: M017 1% Hydrocortisone Anti-itch 1% HYDROCORTISONE ANTI-ITCH ALAINA HEALTHCARE PRIVATE LIMITED b8416467-55f7-4e5f-a5cb-3abd3e2bb577 2026-07-27 Warnings Exact identifier application number: M017 OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH MENTHOL OWELL NATURAL 8 LLC 57984bc2-bf1d-c423-e063-6394a90a06ae 2026-07-27 Warnings Exact identifier application number: M017 Original Pain Relief TOPICAL ANALGESIC LOTION Real Time Pain Relief Inc 579bd303-9a50-4d66-e063-6294a90a6141 2026-07-27 Warnings Exact identifier application number: M017 Lidfix Pain Relief Patch Lidocaine LIDOCAINE HETERO HEALTHCARE LIMITED 2149f0e3-1983-4f02-929e-ecd20357f4bb 2026-07-27 Warnings Exact identifier application number: M017 RectoProtect LIDOCAINE Akron Pharma Inc. 1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb 2026-07-27 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 65197-502-04 65197050204 113 g in 1 CAN (65197-502-04) 113 g 2024-01-01 No No Current