FDA.reportPublic FDA data

Fast Freeze

Product NDC
66902-016
11-digit product format
669020016
Labeler code
66902
Product ID
66902-016_23a8b4cf-a5ed-57c9-e063-6394a90a494b
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Natural Essentials Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-01
Substance
MENTHOL
Active strength
35 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fast Freeze
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL35 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui808955, 1365998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-016-01Fast Freeze1 g in 1 BOTTLE, PUMPGEL14
66902-016-03Fast Freeze1 g in 1 BOTTLEGEL14
66902-016-04Fast Freeze1 g in 1 TUBEGEL14
66902-016-05Fast Freeze1 g in 1 PACKETGEL14
66902-016-16Fast Freeze1 g in 1 BOTTLE, PUMPGEL14
66902-016-32Fast Freeze1 g in 1 BOTTLE, PUMPGEL14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0FAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302FAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-016FAST FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS INC.]4Current NDC, Legacy NDC, 6 package rows20241006_a96e3e41-871c-4cf3-93b6-af2a6246ded8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1365998FAST FREEZE 3.5 % Topical GelPSNa96e3e41-871c-4cf3-93b6-af2a6246ded84
808955menthol 3.5 % Topical GelPSNa96e3e41-871c-4cf3-93b6-af2a6246ded84
1365998menthol 0.035 MG/MG Topical Gel [Fast Freeze Naturally Cool]SBDa96e3e41-871c-4cf3-93b6-af2a6246ded84
808955menthol 0.035 MG/MG Topical GelSCDa96e3e41-871c-4cf3-93b6-af2a6246ded84
1365998Fast Freeze Naturally Cool 0.035 MG/MG Topical GelSYa96e3e41-871c-4cf3-93b6-af2a6246ded84
1365998Fast Freeze Naturally Cool 3.5 % Topical GelSYa96e3e41-871c-4cf3-93b6-af2a6246ded84
808955menthol 3.5 % Topical GelSYa96e3e41-871c-4cf3-93b6-af2a6246ded84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66902-016-01669020016011 g in 1 BOTTLE, PUMP (66902-016-01) 1 g2013-01-010000-00-00NoNoCurrent
66902-016-03669020016031 g in 1 BOTTLE (66902-016-03) 1 g2013-01-010000-00-00NoNoCurrent
66902-016-04669020016041 g in 1 TUBE (66902-016-04) 1 g2013-01-010000-00-00NoNoCurrent
66902-016-05669020016051 g in 1 PACKET (66902-016-05) 1 g2013-01-010000-00-00NoNoCurrent
66902-016-16669020016161 g in 1 BOTTLE, PUMP (66902-016-16) 1 g2013-01-010000-00-00NoNoCurrent
66902-016-32669020016321 g in 1 BOTTLE, PUMP (66902-016-32) 1 g2013-01-010000-00-00NoNoCurrent