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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cryo10 Topical Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui259249

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83549-000-01Cryo10 Topical Analgesic88 mL in 1 BOTTLE, WITH APPLICATORGEL882

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83549-000CRYO10 TOPICAL ANALGESIC (MENTHOL) GEL [ELEMENT 26 LLC]2Current NDC, 1 package rows20231025_ff1d2140-9302-918c-e053-6394a90acb9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259249menthol 10 % Topical GelPSNff1d2140-9302-918c-e053-6394a90acb9a2
259249menthol 0.1 MG/MG Topical GelSCDff1d2140-9302-918c-e053-6394a90acb9a2
259249menthol 10 % Topical GelSYff1d2140-9302-918c-e053-6394a90acb9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83549-000-018354900000188 mL in 1 BOTTLE, WITH APPLICATOR (83549-000-01) 88 ml2023-05-26NoNoCurrent