Home NDC 61566-201 Burn Relief Professional
Product NDC 61566-201
11-digit product format 615660201
Labeler code 61566
Product ID 61566-201_3893cf5b-7ca1-321b-e063-6294a90a9cb5
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine - 4%
Dosage form CREAM
Route TOPICAL
Labeler Kool-Down Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-01-15
Substance LIDOCAINE
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 Burn Relief Professional
Brand name suffix Bio-Kool
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 4 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1421893 Internal RxNorm lookup 2118551 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 61566-201-04 Burn Relief ProfessionalBio-Kool 113 g in 1 BOTTLE CREAM 113 3 61566-201-14 Burn Relief ProfessionalBio-Kool 128 g in 1 JAR CREAM 128 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61566-201 BURN RELIEF PROFESSIONAL BIO-KOOL (LIDOCAINE - 4%) CREAM [KOOL-DOWN INC.] 2 Current NDC, Legacy NDC, 2 package rows 20190223_827e9c69-4706-0ccf-e053-2991aa0aa1c1.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 Marketing end Sample Exclude flag Status 61566-201-04 61566020104 113 g in 1 BOTTLE (61566-201-04) 113 g 2013-01-15 0000-00-00 No No Current 61566-201-14 61566020114 128 g in 1 JAR (61566-201-14) 128 g 2025-06-23 No No Current