RAYO POWER ICE HEAT DUAL ACTION

Product NDC
83033-1602
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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage83033-1602-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage83033-1602-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage83033-1602-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage83033-1602-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage83033-1602-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage83033-1602-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83033-1602-1UExcluded 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 127 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RUGBY HYDROCORTISONE WITH ALOEHYDROCORTISONEA-S Medication Solutionsb2674075-aaa4-4c77-bcaa-a76336b3c3212024-10-02WarningsExact identifier
application number: M017
Herb Street Anti-Itch StickHYDROCORTISONEBalassa Laboratories Inc.8717faae-59c3-4c6f-9ef1-285c0d2445ed2024-10-01WarningsExact identifier
application number: M017
Herb Street Backache and Sore Muscle ReliefMENTHOLBalassa Laboratories Inc.aeac1b64-8689-4b3d-a41c-db41061257b52024-10-01WarningsExact identifier
application number: M017
Herb Street Arthritis ReliefMENTHOL/CAMPHORBalassa Laboratories Inc.a9d8ceb7-def0-415f-8fc1-ff8dd3e418552024-10-01WarningsExact identifier
application number: M017
Lido King Lidocaine 4% Pain Relieving Gel-PatchLIDOCAINEGalaxy Bio, Inc.2243734a-4ea2-a5e5-e063-6294a90aba152024-10-01WarningsExact identifier
application number: M017
Medicated Herbal Lip BalmMENTHOLEarth Mama Angel Baby LLC1cc2391e-6a7a-609c-e063-6394a90a63052024-10-01WarningsExact identifier
application number: M017
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
application number: M017
CircataCAPSAICINPureTek Corporationb67161d7-cc5c-e971-e053-2995a90acbe72024-10-01WarningsExact identifier
application number: M017
MenticamCAMPHOR,MENTHOL, METHYL SALICYLATEPureTek Corporationffea2e97-777f-434b-e053-6394a90a3a632024-10-01WarningsExact identifier
application number: M017
Herb Street Sore Muscle ReliefMETHYL SALICYLATEBalassa Laboratories Inc.e43943c2-d4cd-44c5-a0ff-403a8d42860f2024-10-01WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEKroger Company68dab606-0385-48b7-9a7b-a2cf83d203932024-09-29WarningsExact identifier
application number: M017
kirkland signature hydrocortisone plus maximum strengthHYDROCORTISONECostco Wholesale Company481341c5-db1f-43fb-aed7-f40495a4eab82024-09-29WarningsExact identifier
application number: M017
Care One hydrocortisone maximum strengthHYDROCORTISONEAmerican Sales Company32593229-d0ac-4d6c-831a-089fc6e761522024-09-29WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEL. Perrigo Companyb7a896cc-1d78-45c0-a73e-aa1e117f7d3b2024-09-29WarningsExact identifier
application number: M017
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLCb7362f21-f1a3-4edc-b5b6-a16680e05df32024-09-29WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEH E B412ca2d1-064b-4438-aee1-fcb5cf27c7db2024-09-29WarningsExact identifier
application number: M017
Topcare AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDETopco Associates LLC8c349cac-20e1-4600-9b0a-fcfe929551c52024-09-26WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEA-S Medication Solutions072dd455-24a5-4a44-aaef-d3e137d005a62024-09-26WarningsExact identifier
application number: M017
SYREN Intimate ReliefLIDOCAINE HYDROCHLORIDEIcon Health Science57d5a080-3583-4510-e053-2a91aa0ad5892024-09-25WarningsExact identifier
application number: M017
AOSI HEALTHCAREHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.f4db90ad-dd62-44f1-9655-2614ed36581e2024-09-25WarningsExact 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