burn relief professional bio-kool

Generic: lidocaine - 4%

Labeler: kool-down inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name burn relief professional bio-kool
Generic Name lidocaine - 4%
Labeler kool-down inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

lidocaine 4 g/100g

Manufacturer
Kool-Down Inc.

Identifiers & Regulatory

Product NDC 61566-201
Product ID 61566-201_3893cf5b-7ca1-321b-e063-6294a90a9cb5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2013-01-15

Pharmacologic Class

Established (EPC)
amide local anesthetic [epc] antiarrhythmic [epc]
Chemical Structure
amides [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61566201
Hyphenated Format 61566-201

Supplemental Identifiers

RxCUI
1421893 2118551
UPC
0043399806075
UNII
98PI200987
NUI
N0000175682 M0000897 N0000175426 N0000175976

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name burn relief professional bio-kool (source: ndc)
Generic Name lidocaine - 4% (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 4 g/100g
source: ndc
Packaging
  • 113 g in 1 BOTTLE (61566-201-04)
  • 128 g in 1 JAR (61566-201-14)
source: ndc

Packages (2)

61566-201-04 113 g in 1 BOTTLE (61566-201-04) 61566-201-14 128 g in 1 JAR (61566-201-14)

Ingredients (1)

lidocaine (4 g/100g)

Linked Drug Pages (1)

Burn Relief Professional Bio-Kool ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3893cf5b-7ca1-321b-e063-6294a90a9cb5", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0043399806075"], "unii": ["98PI200987"], "rxcui": ["1421893", "2118551"], "spl_set_id": ["827e9c69-4706-0ccf-e053-2991aa0aa1c1"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["Kool-Down Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "113 g in 1 BOTTLE (61566-201-04)", "package_ndc": "61566-201-04", "marketing_start_date": "20130115"}, {"sample": false, "description": "128 g in 1 JAR (61566-201-14)", "package_ndc": "61566-201-14", "marketing_start_date": "20250623"}], "brand_name": "Burn Relief Professional Bio-Kool", "product_id": "61566-201_3893cf5b-7ca1-321b-e063-6294a90a9cb5", "dosage_form": "CREAM", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "61566-201", "generic_name": "Lidocaine - 4%", "labeler_name": "Kool-Down Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Burn Relief Professional", "brand_name_suffix": "Bio-Kool", "active_ingredients": [{"name": "LIDOCAINE", "strength": "4 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130115", "listing_expiration_date": "20261231"}