FDA.reportPublic FDA data

X-Treme Freeze

Product NDC
67777-144
11-digit product format
677770144
Labeler code
67777
Product ID
67777-144_48fdd7f5-f062-0f63-e063-6294a90a452a
Type
HUMAN OTC DRUG
Nonproprietary name
Cold Therapy Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-17
Substance
MENTHOL
Active strength
4 g/100mL
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
X-Treme Freeze
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4 g/100mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
415974Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
79f0802f-03ad-bf8f-e053-2991aa0ae4b5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-144-10X-Treme Freeze200 in 1 CASEGEL2006
67777-144-11X-Treme Freeze3 mL in 1 PACKETGEL36
67777-144-11X-Treme Freeze100 in 1 BOXGEL1006
67777-144-20X-Treme Freeze24 in 1 CASEGEL246
67777-144-21X-Treme Freeze118 mL in 1 TUBEGEL1186
67777-144-40X-Treme Freeze12 in 1 CASEGEL126
67777-144-41X-Treme Freeze473 mL in 1 BOTTLE, PUMPGEL4736
67777-144-70X-Treme Freeze2 in 1 CASEGEL26
67777-144-71X-Treme Freeze3785 mL in 1 BOTTLE, PLASTICGEL37856

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-144-20ML - Milliliter67777-144c5e5bb15-c596-4135-9b13-a9e2bb6d345012023-02-06
67777-144-21ML - Milliliter67777-144c85e8f2f-7945-46bc-972d-dd9147d19cad12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-144X-TREME FREEZE (COLD THERAPY GEL) GEL [DYNAREX CORPORATION]5Current NDC, Legacy NDC, 9 package rows20241122_79f0802f-03ad-bf8f-e053-2991aa0ae4b5.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 14 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Roll Pain AwayCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547e647b-0205-221c-e063-6294a90a757c2026-06-17WarningsExact identifier
application number: M017
Roll Pain Away LemongrassCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547ef5c0-bc31-d83e-e063-6394a90abfa62026-06-17WarningsExact identifier
application number: M017
Roll Pain Away LavenderCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547ef2d9-f5c7-9de1-e063-6394a90a218b2026-06-17WarningsExact identifier
application number: M017
Velloryn EXTRA STRENGTH NEUROPATHYVELLORYN EXTRA STRENGTH NEUROPATHYGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd547f755f-c65c-37ef-e063-6394a90aa2202026-06-17WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 4 oz.DIMETHICONERNA PHARMA LLC536f4e79-201b-7100-e063-6394a90a4f822026-06-16WarningsExact identifier
application number: M017
Medi First Extra Strength Itch ReliefDIPHENHYDRAMINE, ZINC ACETATEUnifirst First Aid Corporation54614e5b-8c72-d308-e063-6294a90a405d2026-06-16WarningsExact identifier
application number: M017
Blue Ice AnalgesicMENTHOLDelon Laboratories (1990) Ltd184ed488-6e62-40c6-bb71-1d523280fd6b2026-06-16WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1 % Anti-Itch CreamHYDROCORTISONEUnifirst First Aid Corporation49f04e5d-746d-cbe9-e063-6294a90a7e882026-06-16WarningsExact identifier
application number: M017
Lidozall ProLIDOCAINE HYDROCHLORIDEV2 Pharma LLCecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff2026-06-16WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving CoolCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.41590ba1-32bb-4352-97ba-d6a3cc9d05462026-06-15WarningsExact identifier
application number: M017
HIGH POTENCY PAIN RELIEFCAPSAICINXiamen Weisiqi Technology Co., Ltd.543949a4-86ed-3734-e063-6394a90a24f22026-06-14WarningsExact identifier
application number: M017
Natucure HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD49e402ed-d314-e896-e063-6294a90a826b2026-06-14WarningsExact identifier
application number: M017
Nieapf NUMBINGLIDOCAINE 4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e7534f-bccf-4ef4-e063-6294a90aeb7f2026-06-14WarningsExact identifier
application number: M017
HEALMUSZ NUMBINGHEALMUSZ NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49976ff7-49a4-e4ed-e063-6294a90a3f782026-06-14WarningsExact identifier
application number: M017
HEALMUSZ HEMORRHOID FISSURELIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID FISSUREJiangxi Yudexi Pharmaceutical Co., LTD4a342ac0-6a8d-3408-e063-6394a90a9a102026-06-14WarningsExact identifier
application number: M017
BOTASUN QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD4fa00db9-def5-dcfa-e063-6394a90ac8c22026-06-14WarningsExact identifier
application number: M017
HEALMUSZ NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4cbb7df5-5771-ce4b-e063-6294a90aab802026-06-14WarningsExact identifier
application number: M017
HEALMUSZ ECZEMAHYDROCORTISONE 1% ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD511e54e0-2abe-fb76-e063-6294a90ada682026-06-14WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-ItchCreamHYDROCORTISONEAcme United Corporation5425fc2b-4f25-3e64-e063-6394a90aff492026-06-13WarningsExact identifier
application number: M017
Icy Hot Pain Relieving BalmMENTHOL AND METHYL SALICYLATEChattem, Inc.40c8c02f-fa5f-4e80-81a0-48271fa6f94b2026-06-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN79f0802f-03ad-bf8f-e053-2991aa0ae4b56
415974menthol 0.04 MG/MG Topical GelSCD79f0802f-03ad-bf8f-e053-2991aa0ae4b56
415974menthol 4 % Topical GelSY79f0802f-03ad-bf8f-e053-2991aa0ae4b56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-144-1067777014410200 BOX in 1 CASE (67777-144-10) / 100 PACKET in 1 BOX (67777-144-11) / 3 mL in 1 PACKET200 box2018-08-170000-00-00NoNoCurrent
67777-144-11677770144113 mL in 1 PACKET3 mlHistorical
67777-144-206777701442024 TUBE in 1 CASE (67777-144-20) / 118 mL in 1 TUBE (67777-144-21) 24 tube2018-08-170000-00-00NoNoCurrent
67777-144-2167777014421118 mL in 1 TUBE118 mlHistorical
67777-144-406777701444012 BOTTLE, PUMP in 1 CASE (67777-144-40) / 473 mL in 1 BOTTLE, PUMP (67777-144-41) 2018-08-170000-00-00NoNoCurrent
67777-144-4167777014441473 mL in 1 BOTTLE, PUMP473 mlHistorical
67777-144-70677770144702 BOTTLE, PLASTIC in 1 CASE (67777-144-70) / 3785 mL in 1 BOTTLE, PLASTIC (67777-144-71) 2018-08-170000-00-00NoNoCurrent
67777-144-71677770144713785 mL in 1 BOTTLE, PLASTIC3785 mlHistorical