Dermachange Cold Therapy

Product NDC
83520-131
11-digit product format
835200131
Labeler code
83520
Product ID
83520-131_12ef7dd8-3da2-9c87-e063-6394a90ac924
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Private Label Beauty and Wellness
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-27
Substance
MENTHOL
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Dermachange Cold Therapy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2 g/100g

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
311502Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
12ef7dd8-3da3-9c87-e063-6394a90ac924Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83520-131-08Dermachange Cold Therapy227 g in 1 JARGEL2271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83520-131DERMACHANGE COLD THERAPY (MENTHOL) GEL [PRIVATE LABEL BEAUTY AND WELLNESS]1Current NDC, 1 package rows20240307_12ef7dd8-3da3-9c87-e063-6394a90ac924.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 41 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Hydrocortisone Cream with AloeHYDROCORTISONE CREAMWalgreense8f69c4b-2570-477e-9c6d-d552d30ac0d02026-01-14WarningsExact identifier
application number: M017
HydrocortisoneCOOL RELIEF GEL WITH ALOEWalgreens1ae2b37d-d5b2-74d2-e063-6294a90a0de02026-01-14WarningsExact identifier
application number: M017
Maximum Strength Cortisone Cream with AloeHYDROCORTISONE CREAMCVS Pharmacyb95d30b0-6ebd-4989-a6ac-1a42e5d4aba52026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Cream with AloeHYDROCORTISONE CREAMWalgreens61b93226-10ff-43df-b1b6-bcea917a2f482026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreens2112067c-0fbb-400c-9923-b932946e1a122026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreensa7db0a6f-ceca-4e77-bad7-55c3c74413a72026-01-14WarningsExact identifier
application number: M017
CVS Therapeutic Menthol GelMENTHOLCVS Pharmacya02605cd-40d1-4ea1-9828-0695f2d123aa2026-01-14WarningsExact identifier
application number: M017
Maximum Strength CortisoneHYDROCORTISONE OINTMENTCVS Pharmacyf25f2e14-4fc9-4c92-880d-e5f9279d4ecd2026-01-14WarningsExact identifier
application number: M017
Icy Hot with Lidocaine No-MessMENTHOL AND LIDOCAINEChattem, Inc.a2803c07-bf39-4028-9262-5082da25b46e2026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Intensive Moisture CremeHYDROCORTISONEChattem, Inc.096a9af3-7e7c-4dae-bc22-44061c60d3c92026-01-14WarningsExact identifier
application number: M017
Icy Hot DryMENTHOLChattem, Inc.720a85cc-8e98-43f2-9cc8-5636ae09624f2026-01-14WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLChattem, Inc.98ea15e6-972f-44a3-a1e4-abeae538d5a72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Fragrant Ginger PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Brancha0308e0e-1b47-42ab-88ac-b71ff3fa6c472026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Easy ReliefHYDROCORTISONEChattem, Inc.beb73818-cd88-44ff-8ecd-b02b910b53b72026-01-14WarningsExact identifier
application number: M017
diphenhydramine hcl and zinc acetateDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEPadagis Israel Pharmaceuticals Ltd6d7a7615-9ae7-4c55-8a84-dba746f535d72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Cool Herbal PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Branch3b260be8-5e2a-4fba-85d6-2e6c64b970762026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Feminine Itch ReliefHYDROCORTISONEChattem, Inc.c0c0c1fb-43c9-4903-bb3b-f0885619b8cc2026-01-14WarningsExact identifier
application number: M017
Icy Hot Pro Pain Relief Cream w/ microbeadsMENTHOL, CAMPHORChattem, Inc.df5fd485-f583-46b7-a869-16ca2e17185c2026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing CremeHYDROCORTISONEChattem, Inc.4b62615f-e713-42f2-8b9c-9eebf8d1b2702026-01-14WarningsExact identifier
application number: M017
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEChattem, Inc.5767362c-83af-494e-a815-a13f2cb093ef2026-01-14WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSN12ef7dd8-3da3-9c87-e063-6394a90ac9241
311502menthol 0.02 MG/MG Topical GelSCD12ef7dd8-3da3-9c87-e063-6394a90ac9241
311502menthol 2 % Topical GelSY12ef7dd8-3da3-9c87-e063-6394a90ac9241
311502menthol 2 % topical stickSY12ef7dd8-3da3-9c87-e063-6394a90ac9241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83520-131-0883520013108227 g in 1 JAR (83520-131-08) 227 g2023-10-27NoNoCurrent