FDA.reportPublic FDA data

Fast Freeze

Product NDC
66902-015
Requested package NDC
66902-015-04
11-digit product format
669020015
Labeler code
66902
Product ID
66902-015_3c31cff6-6674-9ee4-e063-6294a90a6165
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
SPRAY
Route
TOPICAL
Labeler
Natural Essentials Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-01
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
Fast Freeze
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
667889Internal RxNorm lookup
1365995Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8c42c8d-6ce0-43bf-b165-41979f3d8f79Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-015-04Fast Freeze118 mL in 1 BOTTLE, PUMPSPRAY1186
66902-015-12Fast Freeze118 mL in 1 BOTTLESPRAY1186
66902-015-12Fast Freeze12 in 1 CASESPRAY126
66902-015-16Fast Freeze1 mL in 1 BOTTLE, PUMPSPRAY16
66902-015-27Fast Freeze1 mL in 1 BOTTLE, PUMPSPRAY16
66902-015-44Fast Freeze118 mL in 1 CANSPRAY1186

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AFAST FREEZE (MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AFAST FREEZE (MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0FAST FREEZE (MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XFAST FREEZE (MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FFAST FREEZE (MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302FAST FREEZE (MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFAST FREEZE (MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-015FAST FREEZE (MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]4Current NDC, Legacy NDC, 6 package rows20241006_d8c42c8d-6ce0-43bf-b165-41979f3d8f79.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 86 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ULTRA STRENGTH ZHENG GU SHUIMENTHOL AND CAMPHORGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD53397663-044d-4e48-989b-2c6257af5f842025-07-14Warnings, Adverse reactionsExact identifier
application number: M017
TIGER BALM PAIN RELIEVING HYDROGELCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.cb60037f-bceb-4090-a5e4-bdda0cbf9f5c2025-07-14WarningsExact identifier
application number: M017
Avedana Hydrocortisone Cream with AloeHYDROCORTISONEUnipack LLC2a55c426-39b4-4d94-b6b4-6c548c9685e92025-07-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATERite Aid Corporationcb6e0bed-2ea1-49d2-89e7-2554e7565b742025-07-11WarningsExact identifier
application number: M017
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll OnLIDOCAINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c42025-07-11WarningsExact identifier
application number: M017
Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETARGET Corporation6fba5890-f48f-4302-a8ac-5087a6e03bd52025-07-11WarningsExact identifier
application number: M017
TopCare Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC55dc4025-f07f-41b2-8b18-6a11ee04b5cc2025-07-11WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC309d9be0-e367-429a-a1fa-ab7855477c8a2025-07-10WarningsExact identifier
application number: M017
Bengay Vanishing ScentMENTHOL, UNSPECIFIED FORMKenvue Brands LLC6cc3294b-3b0f-44d0-af71-61db1022d2692025-07-10WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLQuality Choicece544a7c-8dc6-4e63-b499-d8a4e0ec48c32025-07-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATEWalgreen Companybff322f1-59c3-41e0-8685-fcfe52bf4b422025-07-10WarningsExact identifier
application number: M017
CVS CortisoneHYDROCORTISONECVS Pharmacy87631be8-94b8-4718-858d-d2f30e636cce2025-07-10WarningsExact identifier
application number: M017
TopCare Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETopco Associates LLCc40e8e1d-d6d7-4880-99d3-011b97a5e4f32025-07-10WarningsExact identifier
application number: M017
Live Better Hydrocortisone with AloeHYDROCORTISONEThe Great Atlantic & Pacific Tea Company044e6ee2-98a6-4802-b33d-78b8551356c42025-07-10WarningsExact identifier
application number: M017
Rocainol TOPICAL ANALGESICMETHYL SALICYLATE, MENTHOLCompania Internacional de Comercio, S.A.P.I de C.V.827ec7b2-3d87-47e0-a47a-966b25732c322025-07-10WarningsExact identifier
application number: M017
NumbR-XLIDOCAINE HCLProdigy Media Inc16329ab6-4a33-4c38-85e0-5aad9c75d61d2025-07-10WarningsExact identifier
application number: M017
Dr LidoLIDOCAINE HCLProdigy Media Incda0938f0-00e7-4502-8721-d64c71f594fc2025-07-10WarningsExact identifier
application number: M017
Pain Relief PatchCAMPHOR, METHYL SALICYLATE, MENTHOLCDMA, Inc.da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b2025-07-09WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5%MENTHOLLiquidCapsule Manufacturing LLC4fd4b7ac-1971-4abe-8fbb-74ab69e120612025-07-09WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone Plus 12 MoisturizersHYDROCORTISONEAmerisourceBergenf36acdb8-a526-4bb7-a557-e1dcbbc1cf452025-07-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1365995FAST FREEZE Naturally Cool 10 % Topical SprayPSNd8c42c8d-6ce0-43bf-b165-41979f3d8f796
667889menthol 10 % Topical SprayPSNd8c42c8d-6ce0-43bf-b165-41979f3d8f796
1365995menthol 100 MG/ML Topical Spray [Fast Freeze Naturally Cool]SBDd8c42c8d-6ce0-43bf-b165-41979f3d8f796
667889menthol 100 MG/ML Topical SpraySCDd8c42c8d-6ce0-43bf-b165-41979f3d8f796
1365995Fast Freeze Naturally Cool 10 % Topical SpraySYd8c42c8d-6ce0-43bf-b165-41979f3d8f796
1365995Fast Freeze Naturally Cool 100 MG/ML Topical SpraySYd8c42c8d-6ce0-43bf-b165-41979f3d8f796
667889menthol 10 % Topical SpraySYd8c42c8d-6ce0-43bf-b165-41979f3d8f796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66902-015-0466902001504118 mL in 1 BOTTLE, PUMP (66902-015-04) 118 ml2013-01-010000-00-00NoNoCurrent