Home NDC 65197-512 Solarcaine Burn Pain Relief 4oz
Product NDC 65197-512
11-digit product format 651970512
Labeler code 65197
Product ID 65197-512_6c821db0-8d38-4fd0-ad6e-7215f7b1cd83
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 2024-11-15
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 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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65197-512-04 Solarcaine Burn Pain Relief 4oz 113 g in 1 CAN SPRAY 113 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-512 SOLARCAINE BURN PAIN RELIEF 4OZ (SOLARCAINE BURN PAIN RELIEF 4OZ) SPRAY [WELLSPRING PHARMACEUTICAL CORPORATION] 2 Current NDC, 1 package rows 20250110_2c0389db-ceb2-422b-9575-bdb8fe649a1e.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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65197-512-04 65197051204 113 g in 1 CAN (65197-512-04) 113 g 2024-11-15 No No Current