FDA.reportPublic FDA data

Cold and Hot Medicated

Product NDC
10742-1117
11-digit product format
107421117
Labeler code
10742
Product ID
10742-1117_292bbecc-0909-ea75-e063-6394a90a7e64
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-01
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
500 mg/1
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
Cold and Hot Medicated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM500 mg/1

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
85bf425d-59d7-4462-ba46-292145460099Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-1117-12023-02-14C16284748780-1f386c649-cd46-0266-e053-dadaa90a7c1aDrug Facts - Cold and Hot Medicated
10742-1117-12023-01-30C16284748780-1f386c649-cd46-0266-e053-dadaa90a7c1aDrug Facts - Cold and Hot Medicated

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-1117-1Cold and Hot Medicated5 in 1 POUCHPATCH56
10742-1117-1Cold and Hot Medicated1 in 1 CARTONPATCH16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ACOLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
MENTHOLACTIVE MOIETYL7T10EIP3ACOLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31COLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311COLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GCOLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6COLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCOLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTCOLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6WCOLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990COLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
SORBITOLINACTIVE INGREDIENT506T60A25RCOLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCOLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RCOLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-1117COLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]6Current NDC, Legacy NDC, 2 package rows20241215_85bf425d-59d7-4462-ba46-292145460099.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 1 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
application number: M017
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
application number: M017
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
NeuroNesic Pain Relieving CreamCAPSAICINBlaine Labs Inc.7107c13d-bf59-4c0a-84fe-725a9fca26912026-09-04WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsExact identifier
application number: M017
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
application number: M017
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
application number: M017
Komxsum LIDOCAINE CreamLIDOCAINE 4% CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9feae0-9be4-e736-e063-6294a90abe552026-09-03WarningsExact identifier
application number: M017
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
application number: M017
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
application number: M017
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact identifier
application number: M017
Ramedica Herbal Wonder BalmCAMPHOR, MENTHOLRamedicare Sdn. Bhd.cfb2ea0e-a1f6-4fdf-b866-346bbe78788f2026-09-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN85bf425d-59d7-4462-ba46-2921454600996
420222menthol 0.05 MG/MG Medicated PatchSCD85bf425d-59d7-4462-ba46-2921454600996
420222menthol 5 % Medicated PatchSY85bf425d-59d7-4462-ba46-2921454600996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-1117-1107421117011 POUCH in 1 CARTON (10742-1117-1) / 5 PATCH in 1 POUCH1 pouch2014-07-010000-00-00NoNoCurrent