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 141 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Regular Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS87473ace-d834-e43f-e053-2a95a90a819c2023-12-11WarningsExact identifier
application number: M017
Katinko External Analgesic OilCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.5881fc35-3293-4f0b-801a-afcd6feb94962023-12-08WarningsExact identifier
application number: M017
Katinko Pain And Itch RelievingCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.fe907fa4-4a01-4974-b71f-9cd980b4eaa22023-12-08Warnings, Adverse reactionsExact identifier
application number: M017
CycleMENTHOLLa Mend, Inc.cfc0bcde-ef91-1e6c-e053-2a95a90ab79e2023-12-07WarningsExact identifier
application number: M017
Hemorrhoidal Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
application number: M017
Quatriderm Anti-itchHYDROCORTISONEOPMX LLC83e59e10-9878-e5c2-e053-2a91aa0af25e2023-12-04WarningsExact identifier
application number: M017
TACTDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLSato Pharmaceutical Inc., Ltd.b6e2ee24-69de-4dfd-9081-b9537b7a7bad2023-12-04WarningsExact identifier
application number: M017
Overnight Cold Therapy Pain ReliefMENTHOL, UNSPECIFIED FORMWalgreen Co.2cbd0966-4cf9-4271-bd53-6672b1ed2a992023-12-04WarningsExact identifier
application number: M017
Prolayed Lidocaine Male Genital DesensitizerLIDOCAINEViaDerma Distribution, Inc.9c5ad0d0-ca7a-4321-9334-f06f3f6be18f2023-12-02WarningsExact identifier
application number: M017
Liberdol Topical AnalgesicMETHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)ViaDerma Distribution, Incab52cd0e-34fa-41c7-9ce7-1183c2aff8d82023-12-01WarningsExact identifier
application number: M017
ProlayedLIDOCAINEMATRIX MIXOLOGY, INCae317876-adb1-6d13-e053-2995a90a74af2023-12-01WarningsExact identifier
application number: M017
Tact Cool JellyDIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOLSato Pharmaceutical Co., Ltd.f34872c9-91b9-49db-8e41-5b54a069284a2023-12-01WarningsExact identifier
application number: M017
SatohapMETHYL SALICYLATE, DL-CAMPHOR, L-MENTHOLSato Pharmaceutical Co., Ltd.348fde05-2797-4410-a1b2-99e64187c4fe2023-12-01WarningsExact identifier
application number: M017
Menthozen HydrogelMENTHOL, CAPSAICINProficient Rx LP85a7809e-c43f-4138-a85b-44e1b586def52023-12-01WarningsExact identifier
application number: M017
Menthozen CreamMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP66681906-c5f5-4c57-bb43-9c83cccc00622023-12-01WarningsExact identifier
application number: M017
Lidozen PatchLIDOCAINE, MENTHOLProficient Rx LPc0df4b8b-2679-4652-9144-a8db916a186b2023-12-01WarningsExact identifier
application number: M017
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LP7c300dec-cefd-4b79-a948-a917b7708a042023-12-01WarningsExact identifier
application number: M017
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP2adf3c4d-636f-4e02-b501-946b4df5f5d62023-12-01WarningsExact identifier
application number: M017
LidozenLIDOCAINE, MENTHOLProficient Rx LP488d665c-a4fe-4a69-bab3-34b2347f4b052023-12-01WarningsExact identifier
application number: M017
Thera Plus Max Strength Lidocaine Pain Relief LiquidLIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.0a228b06-0e1c-6c75-e063-6294a90a9a0e2023-11-30WarningsExact 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