FDA.reportPublic FDA data

Hot/Cold Medicated Patch

Product NDC
67777-201
11-digit product format
677770201
Labeler code
67777
Product ID
67777-201_304db1ab-acd9-43d5-e063-6294a90aeec2
Type
HUMAN OTC DRUG
Nonproprietary name
Hot Cold Patch
Dosage form
PATCH
Route
TOPICAL
Labeler
Dynarex
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-13
Substance
MENTHOL
Active strength
285 mg/5700mg
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
Hot/Cold Medicated Patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL285 mg/5700mg

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
999881b3-287e-d975-e053-2995a90a87e3Available 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
67777-201-08Hot/Cold Medicated Patch36 in 1 CASEPATCH365
67777-201-09Hot/Cold Medicated Patch285 mg in 1 PATCHPATCH2855
67777-201-09Hot/Cold Medicated Patch3 in 1 BAGPATCH35
67777-201-10Hot/Cold Medicated Patch36 in 1 CASEPATCH365
67777-201-11Hot/Cold Medicated Patch5 in 1 BOXPATCH55
67777-201-11Hot/Cold Medicated Patch285 mg in 1 PATCHPATCH2855
67777-201-20Hot/Cold Medicated Patch36 in 1 CASEPATCH365
67777-201-21Hot/Cold Medicated Patch285 mg in 1 PATCHPATCH2855
67777-201-21Hot/Cold Medicated Patch5 in 1 BOXPATCH55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-201HOT/COLD MEDICATED PATCH (HOT COLD PATCH) PATCH [DYNAREX]5Current NDC, Legacy NDC, 9 package rows20250321_999881b3-287e-d975-e053-2995a90a87e3.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 131 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited0e808f89-62dc-3790-e063-6394a90a23512024-05-13WarningsExact identifier
application number: M017
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold GelCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1794c512-5f42-4ec3-e063-6394a90a87cd2024-05-03WarningsExact identifier
application number: M017
Professional Therapy MuscleCare ProMENTHOL AND CAMPHORACTIVE AND INNOVATIVE, LLC17961a84-6bee-c75f-e063-6394a90af5762024-05-03WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Pain Relieving CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd2024-05-01WarningsExact identifier
application number: M017
Lidocaine HCl 4 PercentLIDOCAINE HYDROCHLORIDEARI BRANDS, LLC81aff5c5-91c0-4173-a432-d201156135802024-04-30WarningsExact identifier
application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 BulkCAMPHOR,MENTHOL, METHYL SALICYLATEVeridian Healthcare17545078-05e1-9338-e063-6394a90a678c2024-04-30WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Roll-onCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1755ec89-c404-1c17-e063-6394a90ab9fb2024-04-30WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bc2a14-6bda-428c-e053-2995a90a4ced2024-04-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN999881b3-287e-d975-e053-2995a90a87e35
420222menthol 0.05 MG/MG Medicated PatchSCD999881b3-287e-d975-e053-2995a90a87e35
420222menthol 5 % Medicated PatchSY999881b3-287e-d975-e053-2995a90a87e35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-201-086777702010836 BAG in 1 CASE (67777-201-08) / 3 PATCH in 1 BAG (67777-201-09) / 285 mg in 1 PATCH36 bag2019-12-13NoNoCurrent
67777-201-0967777020109285 mg in 1 PATCH285 mgHistorical
67777-201-106777702011036 BOX in 1 CASE (67777-201-10) / 5 PATCH in 1 BOX (67777-201-11) / 285 mg in 1 PATCH36 box2019-12-130000-00-00NoNoCurrent
67777-201-11677770201115 in 1 BOXHistorical
67777-201-206777702012036 BOX in 1 CASE (67777-201-20) / 5 PATCH in 1 BOX (67777-201-21) / 285 mg in 1 PATCH36 box2019-12-130000-00-00NoNoCurrent
67777-201-2167777020121285 mg in 1 PATCH285 mgHistorical