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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4dfc77bb-11dd-e0f0-e063-6294a90a4e9c2026-07-24WarningsExact identifier
application number: M017
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a5b47ce-2bf1-42c7-e063-6294a90af09f2026-07-23WarningsExact identifier
application number: M017
DERMFREE WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c63b3-44de-8736-e063-6394a90ac21a2026-07-23WarningsExact identifier
application number: M017
DERMFREE Anti-itchHYDROCORTISONE1% ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a5af4c6-555a-e74c-e063-6394a90aa6ce2026-07-23WarningsExact identifier
application number: M017
DERMFREE HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4a5d0e79-d620-0147-e063-6294a90a31032026-07-23WarningsExact identifier
application number: M017
MAG 5 PT WARMING FORMULAMENTHOLRENU LABORATORIES, LLCa499ac9b-0e8e-e23f-e053-2a95a90abe9a2026-07-23WarningsExact identifier
application number: M017
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
application number: M017
Numbing Pain ReliefLIDOCAINE 4%Walgreen Company2425badb-e196-e9f8-e063-6294a90a7bf42026-07-22WarningsExact identifier
application number: M017
Cooling Pain ReliefMENTHOL 4.5%Walgreen Company24345ccf-c96f-31b0-e063-6294a90a82b52026-07-22WarningsExact identifier
application number: M017
Heat Pain ReliefCAPSAICIN 0.1%Walgreen Company2434f9cf-74aa-17af-e063-6294a90a56d92026-07-22WarningsExact identifier
application number: M017
Pain Relief Patch LidocaineLIDOCAINEHyVee41c26a66-3371-2c2c-e063-6294a90aa38b2026-07-22WarningsExact identifier
application number: M017
CVS Ultra Strength MuscleMENTHOL, CAMPHOR, METHYL SALICYLATECVS Pharmacy48bef8bc-6e39-a328-e063-6394a90ae4502026-07-22WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative573c2d85-9e0b-7955-e063-6394a90aff642026-07-22WarningsExact identifier
application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
application number: M017
Bclsks NUMBINGMENTHOL 1% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e26770-ddf6-7515-e063-6394a90a4ab32026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact 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