COLD AND HOT MEDICATED Patch

Product NDC
83559-014
11-digit product format
835590014
Labeler code
83559
Product ID
83559-014_49ac6a7b-25d4-6dc4-e063-6394a90a99b6
Type
HUMAN OTC DRUG
Nonproprietary name
COLD AND HOT MEDICATED Patch
Dosage form
PATCH
Route
TOPICAL
Labeler
Henan Enokon Medical Instrument Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-31
Substance
MENTHOL
Active strength
5 g/1001
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
COLD AND HOT MEDICATED Patch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5 g/1001

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
420222Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
49ac6a7b-25d3-6dc4-e063-6394a90a99b6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83559-014-01COLD AND HOT MEDICATED Patch2 in 1 POUCHPATCH21
83559-014-01COLD AND HOT MEDICATED Patch24 in 1 BOXPATCH241

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 131 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1bc2f688-d0c4-690e-e063-6294a90abc382024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1b9fdac0-9fb0-e669-e063-6394a90aece92024-06-24WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAsclemed USA, Inc.97d506bd-3215-4e2e-9914-af1c174dd4ab2024-06-20WarningsExact identifier
application number: M017
ABREVA Rapid Pain ReliefGLYCERIN, LIDOCAINEHaleon US Holdings LLC65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d2024-06-20WarningsExact identifier
application number: M017
Frankie Avalons ZERO PAIN Roll-On Pain RelieverCAPSAICINWHY ENTERPRISES LLCe32acb5f-5bc3-4228-b037-6315d080f5562024-06-17WarningsExact identifier
application number: M017
PUREGEN LABS Pain Relief 4 LidocaineLIDOCAINEAdvanced Rx LLC9dff40d8-8d7e-4629-bea5-987f5e68477d2024-06-11WarningsExact identifier
application number: M017
SMOOTH GATOR Head-Ezz AnalgesicMENTHOLSmooth Gator LLC02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd2024-06-10WarningsExact identifier
application number: M017
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDEEpic Medical Supply Corpbd1b1873-e900-45eb-96a0-28f782b5a7cd2024-06-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEChain Drug Marketing Association Inc.1c834ba0-86b6-8e61-e063-6394a90a192d2024-06-04WarningsExact identifier
application number: M017
HealthWise Feminine Anti-itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare19fe7c3b-58e2-6c16-e063-6394a90a612a2024-06-03WarningsExact identifier
application number: M017
THE SOLUTION NUMBINGLIDOCAINE HYDROCHLORIDESCALP TECH INC184be4cc-b0b9-7882-e063-6394a90a8e7e2024-05-25WarningsExact identifier
application number: M017
Methyl Salicylate 25 PercentMETHYL SALICYLATEAlexso, Incd8b8b0ba-69e9-4965-bf9b-6db21db69b342024-05-23WarningsExact identifier
application number: M017
Meijer Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILMeijer Distribution07ecc6a7-bbe3-35cf-e063-6394a90a21802024-05-22WarningsExact identifier
application number: M017
TheraCare Hydrocortisone CreamHYDROCORTISONEVeridian Healthcare01cb7b47-2c3c-707d-e063-6294a90a5d972024-05-21WarningsExact identifier
application number: M017
TheraCare 4% Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcarec808aa05-9d49-cc9f-e053-2a95a90a50f32024-05-21WarningsExact identifier
application number: M017
TheraCare 4% Lidocaine and 1% Menthol CreamMENTHOL AND LIDOCAINEVeridian Healthcarec80ba251-91a5-0858-e053-2995a90a9cff2024-05-21WarningsExact identifier
application number: M017
HealthWise Menthol Roll-OnMENTHOLVeridian Healthcare102d57a5-6449-f825-e063-6294a90a88442024-05-21WarningsExact identifier
application number: M017
SAFLY BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.3aca2568-d10f-4b14-861b-6c741c1068292024-05-17WarningsExact identifier
application number: M017
HealthWise Menthol 4% Roll-OnMENTHOLVeridian Healthcare1894ef00-ba05-0e02-e063-6394a90ab9822024-05-16WarningsExact identifier
application number: M017
Leader Poison Ivy WashPRAMOXINE HYDROCHLORIDE LOTIONCardinal Health, 110 dba Leader81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c2024-05-13WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN49ac6a7b-25d3-6dc4-e063-6394a90a99b61
420222menthol 0.05 MG/MG Medicated PatchSCD49ac6a7b-25d3-6dc4-e063-6394a90a99b61
420222menthol 5 % Medicated PatchSY49ac6a7b-25d3-6dc4-e063-6394a90a99b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83559-014-018355900140124 POUCH in 1 BOX (83559-014-01) / 2 PATCH in 1 POUCH24 pouch2026-01-31NoNoCurrent