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 105 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OKeeffes Working Hands Pain Relief Skin ProtectantALLANTOIN, LIDOCAINE HYDROCHLORIDEThe Gorilla Glue Company/O'Keeffe's Company0685da25-c9fa-e1cd-e063-6394a90ae1b32025-01-01WarningsExact identifier
application number: M017
Icy Hot with Lidocaine Pain RelievingLIDOCAINE HCL AND MENTHOLChattem, Inc.75b28b06-77ea-4fea-b516-2e8a0dac70372025-01-01WarningsExact identifier
application number: M017
Advanced Seal Barrier plus Pain ReliefLIDOCAINEKericure Inc.7ac95325-e6e9-4c56-9315-876c00af7c982025-01-01WarningsExact identifier
application number: M017
FixMySkin Healing Balm Fragrance-FreeHYDROCORTISONELovely Skin, Inc.c12af4c6-2f05-46ec-b901-1a4fcd7501802024-12-31WarningsExact identifier
application number: M017
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
application number: M017
Cold Therapy Pain Relief WalgreensMENTHOL 10.5%WALGREEN COMPANYf1daa68d-1b12-c28a-e053-2995a90a09492024-12-31WarningsExact identifier
application number: M017
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAdvanced Rx of Tennessee, LLC0b7736df-c7e0-7d00-e063-6294a90aa57e2024-12-31WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAdvanced Rx Pharmacy of Tennessee, LLCf4bfc4a6-06ef-1f76-e053-2995a90a2b8f2024-12-31WarningsExact identifier
application number: M017
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLC01cb19a4-ce22-144d-e063-6294a90a8aa32024-12-31WarningsExact identifier
application number: M017
Satohap Lidocaine 4% Menthol 1% Pain Relieving CreamLIDOCAINE, MENTHOLSato Pharmaceutical Co., Ltd.2251e96b-d050-4ec2-a6b9-6659610885bf2024-12-30WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONESafewayaf2e2ef3-0f3f-4592-8081-b6553ade2f5a2024-12-26WarningsExact identifier
application number: M017
Comforte Menstrual Cramp Relief CreamMENTHOLPMS4PMS LLCc121537e-3333-4f35-8c77-20086158dff42024-12-26WarningsExact identifier
application number: M017
N-Labs Arcticzen Pain Relief KneeCAMPHOR (SYNTHETIC), MENTHOLNUTRIOMO LABS PTE. LTD05ee574a-854c-4a77-be77-082055075c4d2024-12-26WarningsExact identifier
application number: M017
BiteMD External Analgesic First Aid AntisepticBENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOLUnited Industries Corporation4c60db03-6d2b-4ae0-a200-718b3a50eb0f2024-12-23WarningsExact identifier
application number: M017
GNP Anti ItchCAMPHOR, MENTHOLAMERISOURCEBERGEN DRUG CORPORATIONb4f2d6f7-2287-47d8-e053-2995a90ae3352024-12-23WarningsExact identifier
application number: M017
cool and heat pain relieving liquidMENTHOLBionpharma Inc.ec6f59d8-45c5-46a0-e053-2995a90a239f2024-12-23WarningsExact identifier
application number: M017
FOOT WORKS MAXIMUM CRACKED HEELBENZALKONIUM CHLORIDE, LIDOCAINECOSMAX USA, CORPORATION29f92230-d1d4-5e94-e063-6294a90af8122024-12-23WarningsExact identifier
application number: M017
pain relief roll-onLIDOCAINE 4%Bionpharma Inc.f607b6dc-8d13-604a-e053-2995a90a59ab2024-12-23WarningsExact identifier
application number: M017
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMiramar Cosmetics, Inc DBA Miramar Laba6c4889c-e7a9-44b9-bd9a-70fd6e8c48252024-12-23WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONE 1%Trifecta Pharmaceuticals USA LLCaf5daf6c-bcad-8ebf-e053-2a95a90af1b02024-12-20WarningsExact 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