FDA.reportPublic FDA data

RAYO POWER ICE HEAT DUAL ACTION

Product NDC
83033-1602
Requested package NDC
83033-1602-1
11-digit product format
830331602
Labeler code
83033
Product ID
83033-1602_48f80d39-675a-af9d-e063-6294a90a2eed
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Quimicas Handal de Centroamerica SA de CV
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-01
Substance
MENTHOL
Active strength
1 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
RAYO POWER ICE HEAT DUAL ACTION
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
09e4a36b-020a-c5b1-e063-6394a90a3e31Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83033-1602-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1602-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83033-1602-1RAYO POWER ICE HEAT DUAL ACTION80 g in 1 TUBE, WITH APPLICATORGEL803
83033-1602-1RAYO POWER ICE HEAT DUAL ACTION1 in 1 BOXGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83033-1602RAYO ACTIVE HEAT (MENTHOL, METHYL SALICYLATE ) CREAM RAYO ACTIVE ICE (MENTHOL, CAMPHOR) CREAM RAYO BREATH CHAMOMILE (MENTHOL, CAMPHOR) CREAM RAYO BREATH MENTHOL (MENTHOL, CAMPHOR) CREAM RAYO POWER ICE HEAT DUAL ACTION (MENTHOL) GEL RAYO BREATH CHAMOMILE (MENTHOL, CAMPHOR) OINTMENT RAYO ACTIVE ICE SACHET (MENTHOL, CAMPHOR) CREAM [QUIMICAS HANDAL DE CENTROAMERICA SA DE CV]2Current NDC, 2 package rows20250504_09e4a36b-020a-c5b1-e063-6394a90a3e31.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 74 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KinesysZINC OXIDEWilc Healthcare Inca32b44c3-eda0-48ea-95fc-250a2c2396ca2025-10-10WarningsExact identifier
application number: M017
Te-Fu Recovery MassageMENTHOL, METHYL SALICYLATEWasatch Product Development7bc2989f-dfb6-e8af-e053-2991aa0a0bf22025-10-10WarningsExact identifier
application number: M017
Anti-itchHYDROCORTISONEMedline Industries, LPb0947381-c0db-4253-ab40-3d45603ae65d2025-10-09WarningsExact identifier
application number: M017
Kalaya Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe2452c4b-2548-497f-828b-5d960402522a2025-10-08WarningsExact identifier
application number: M017
Kalaya Pain Relief 6X with ArnicaPAIN RELIEF CREAMAvaria Health & Beauty Corp60198d2e-4de3-3fa0-e053-2a91aa0afaf72025-10-08WarningsExact identifier
application number: M017
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp9b9b7cad-a5e2-4445-856b-4aa439d77a802025-10-08WarningsExact identifier
application number: M017
KALAYA FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpd5021e6d-f29f-446b-874c-bdcabd9cf4f62025-10-08WarningsExact identifier
application number: M017
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe0c9f22a-165a-4558-ba3c-8592f1bd00162025-10-08WarningsExact identifier
application number: M017
Kalaya Extra Strength Pain Relief Cream with Hemp Seed OilMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp2eccf23c-fae2-423c-9cae-549bc41941042025-10-08WarningsExact identifier
application number: M017
KALAYA BACK AND NECK PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp48fd73e7-1443-4ac7-bf7c-d99bf2449f512025-10-08WarningsExact identifier
application number: M017
Lidocaine Pain Relieving PatchLIDOCAINE 4%BluePoint Laboratories3117273d-e006-2726-e063-6294a90a9c332025-10-08WarningsExact identifier
application number: M017
EQUATE PAIN RELIEVING PATCHESLIDOCAINE 4%WALMART, INC01e1cc0e-e1c9-d274-e063-6294a90a409e2025-10-08WarningsExact identifier
application number: M017
Equate Pain Relief BalmMENTHOL 11%, CAMPHOR 11% OINTMENTWALMART, INCd8ddf835-f008-ce1f-e053-2a95a90aa9b32025-10-08WarningsExact identifier
application number: M017
TheraCare Pain Relieving Menthol GelMENTHOL 2%Veridian Healthcare9d2ccb02-746c-4cb9-905d-280987778f4d2025-10-08WarningsExact identifier
application number: M017
COOLING PAIN RELIEFMENTHOL, CAMPHORSUNSET NOVELTIES, INC3a9019b1-8798-1ef9-e063-6394a90a09a42025-10-08WarningsExact identifier
application number: M017
Coralite Capsaicin Heat Patch 2ctCAPSAICINUnited Exchange Corp.4128b1ac-f540-2611-e063-6294a90ac98b2025-10-08WarningsExact identifier
application number: M017
Ombre Men overtime wipesBENZOCAINESambria Pharmaceuticals, LLC405f23ca-99c1-4db4-aba1-2fd7f93f55ee2025-10-07WarningsExact identifier
application number: M017
Pain free IVLIDOCAINESambria Pharmaceuticals, LLC7aa4cb20-d452-417f-afdb-307df754ed752025-10-07WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONECVS PHARMACY, INCb3bdff5e-37fe-442a-a370-7b19799ea7812025-10-07WarningsExact identifier
application number: M017
HealthWise Pain Relief PatchMENTHOL, METHYL SALICYLATEVeridian Healthcareb65932fd-ee9f-4fa2-b842-01e0f54133c92025-10-07WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83033-1602-1830331602011 TUBE, WITH APPLICATOR in 1 BOX (83033-1602-1) / 80 g in 1 TUBE, WITH APPLICATOR2023-11-01NoNoCurrent