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
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
MENTHOL35 mg/g

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
808955Internal RxNorm lookup
1365998Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a96e3e41-871c-4cf3-93b6-af2a6246ded8Available on FDA.report

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

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 150 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLCe43e2cbd-d114-4b11-8baf-7a775881cd972023-11-06WarningsExact identifier
application number: M017
Celadrin Joint and Muscle Pain RelievingMENTHOLFactors Group of Nutritional Products6396e4b6-2130-433b-bdb3-97c76dbe685c2023-11-06WarningsExact identifier
application number: M017
Atomic BalmMETHYL SALICYLATE, CAPSAICINThe Hygenic Company, LLCd10028f3-ae6a-7b01-e053-2995a90a5a842023-11-05WarningsExact identifier
application number: M017
HEMPCIN Advanced Topical Pain Relief CreamMENTHOLPedicis Research, LLC97f5e300-b780-4694-a681-60d5e0cfad652023-11-05WarningsExact identifier
application number: M017
Point Relief cold Spot Pain Relieving roll-onMENTHOLFabrication Enterprises3f1db0ad-aaa8-4e14-9349-45057e0fb4a62023-11-05WarningsExact identifier
application number: M017
LidoStatLIDOCAINE HCLClinical Therapeutic Solutions1825885b-9141-4515-bb69-a1c4a39fb10d2023-11-05WarningsExact identifier
application number: M017
Point Relief Cold Spot Pain RelievingMENTHOLFabrication Enterprises391af69f-74aa-48cf-bc96-75e5c4e0e4452023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS NATURAL PAINMENTHOLThe Feel Good Lab778b62a1-ebd3-4a30-8f76-6d6773b698c52023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS SPORT RECOVERYMENTHOLThe Feel Good Lab103c5e33-42fb-41ac-957e-bb46d85e204c2023-11-05WarningsExact identifier
application number: M017
INSTA RELIEF DMLIDOCAINE HYDROCHLORIDE, MENTHOLDM LAB CORP6ef66fb9-9f49-409d-9503-175c7555ee9e2023-11-05WarningsExact identifier
application number: M017
DR. MIKES Ponos Pain Relief Cream Roll-OnHISTAMINE DIHYDROCHLORIDE, MENTHOLDr. Mike's Vitamins, LLCfcc45464-f1fe-4244-95a7-9b4288b0ce452023-11-05WarningsExact identifier
application number: M017
AcuPlus Pain ReliefMENTHOLInnovations for Wellness, LLC7f222a4f-85a8-4f3d-aa97-5c695d4da37f2023-11-05WarningsExact identifier
application number: M017
Ana Cool Rapid Soothing Cooling FormulaHYDROCORTISONEAna-Cool, LLC64b80cc2-e2d8-4535-aaf8-c031f4159cd12023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS SPORT RECOVERYMENTHOLTHE FEEL GOOD LAB, LLC19b08cbf-5f43-4f07-8f4d-8cddb1492ab82023-11-05WarningsExact identifier
application number: M017
PlayMakar Roll On Cool Pain ReliefMENTHOLPlayMakar Inc.a12c16e7-561f-45a7-93c6-34d693ffdc7c2023-11-05WarningsExact identifier
application number: M017
AcuPlus Advanced Therapy for Pain and RecoveryMENTHOLINNOVATIONS FOR WELLNESS, LLC840cfd15-4ea1-49bf-8c4f-86c12461d8602023-11-05WarningsExact identifier
application number: M017
SCLERA CARE Topical Anesthetic GelLIDOCAINE HYDROCHLORIDEScleraCare, LLC488ace02-fc0b-4d13-ab89-0e1640e915e52023-11-05WarningsExact identifier
application number: M017
IRELIEV ROLL ON COOL PAIN RELIEFMENTHOLExcel Health, Incdab94995-7393-4d9c-b295-72611a90919b2023-11-05WarningsExact identifier
application number: M017
URIFLEX Fast Acting Analgesic Pain ReliefMENTHOLRejuvica LLCfb78f705-b838-461d-b42c-8c98d3ca5d092023-11-05WarningsExact identifier
application number: M017
365 Medicated Lip BalmMEDICATED LIP BALMWhole Foods Market, Inc.48309a7d-d2da-483c-8bf8-f59d9ad0bb732023-11-03WarningsExact identifier
application number: M017

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