Home NDC 83549-000 Cryo10 Topical Analgesic
Product NDC 83549-000
11-digit product format 835490000
Labeler code 83549
Product ID 83549-000_08853630-67a7-fee9-e063-6394a90a4c1e
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form GEL
Route TOPICAL
Labeler Element 26 LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-26
Substance MENTHOL
Active strength 100 mg/mL
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 Cryo10 Topical Analgesic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259249 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83549-000-01 Cryo10 Topical Analgesic 88 mL in 1 BOTTLE, WITH APPLICATOR GEL 88 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83549-000 CRYO10 TOPICAL ANALGESIC (MENTHOL) GEL [ELEMENT 26 LLC] 2 Current NDC, 1 package rows 20231025_ff1d2140-9302-918c-e053-6394a90acb9a.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 83549-000-01 83549000001 88 mL in 1 BOTTLE, WITH APPLICATOR (83549-000-01) 88 ml 2023-05-26 No No Current