FDA.reportPublic FDA data

RAYO ACTIVE ICE SACHET

Product NDC
83033-1609
11-digit product format
830331609
Labeler code
83033
Product ID
83033-1609_48f80d39-675a-af9d-e063-6294a90a2eed
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, CAMPHOR
Dosage form
CREAM
Route
TOPICAL
Labeler
Quimicas Handal de Centroamerica SA de CV
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-01
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
1; 1 g/g; 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 packagepackage83033-1609-1IInactivated 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 packagepackage83033-1609-1IInactivated 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 packagepackage83033-1609-1IInactivated 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 packagepackage83033-1609-1IInactivated 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 packagepackage83033-1609-1UExcluded 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 packagepackage83033-1609-1UExcluded 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 packagepackage83033-1609-1UExcluded 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 ACTIVE ICE SACHET
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1 g/g
CAMPHOR (SYNTHETIC)1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
LAV5U5022YInternal 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
83033-1609-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1609-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83033-1609-1RAYO ACTIVE ICE SACHET4 g in 1 POUCHCREAM43
83033-1609-1RAYO ACTIVE ICE SACHET1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83033-1609RAYO 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 105 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation9654f5cd-74d7-44a2-9674-666d1e94ffa72025-09-08WarningsExact identifier
application number: M012
Otis Clapp MygrexACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationf196f2c5-a100-42b1-bd01-0327b223838e2025-09-08WarningsExact identifier
application number: M012
Medique DiphenDIPHENHYDRAMINE HYDROCHLORIDEUnifirst First Aid Corporationb61ee2e0-2543-447d-9fc4-23363d46ce042025-09-08WarningsExact identifier
application number: M012
Green Guard Allergy 2 ReliefPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation16fddca9-a66b-41e6-9423-eaf091d3971e2025-09-08WarningsExact identifier
application number: M012
Medique Medi-PhenylPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationd7d62ac1-1333-4366-884b-26537766ce382025-09-08WarningsExact identifier
application number: M012
Unishield Sinus DecongestantPHENYLEPHRINE HCLUnishieldb8f68d9d-2d38-414a-e053-2a95a90a15ec2025-09-08WarningsExact identifier
application number: M012
McKesson Sinus Pain and Pressure ReliefACETAMINOPHEN, PHENYLEPHRINE HCLMcKesson Medical-Surgicale0cbb213-4f4f-4045-e053-2a95a90a2a182025-09-08WarningsExact identifier
application number: M012
Medique Medicidin DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation1f172d58-4050-424b-9743-130d8e618fe82025-09-08WarningsExact identifier
application number: M012
Medique Cold Cough ProductACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,Unifirst First Aid Corporatione8059137-efba-398c-e053-2a95a90a21f22025-09-08WarningsExact identifier
application number: M012
Medique Medi-MucusDEXTROMETHORPHAN HBR, GUAIFENESINUnifirst First Aid Corporationf3bb862a-9cb8-f644-e053-2a95a90a5f4f2025-09-08WarningsExact identifier
application number: M012
Physicians Care Cough and Sore ThroatMENTHOLAcme United Corporation4e02223d-f34b-333e-e054-00144ff8d46c2025-09-08WarningsExact identifier
application number: M012
Physicians Care Non-Drowsy Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAcme United186ec543-1f23-75d6-e063-6294a90a46b92025-09-08WarningsExact identifier
application number: M012
PhysiciansCare Sinus Non-DrowsyPHENYLEPHRINE HCLAcme United Corporationa6daf3ef-f386-4de4-b38e-d0b90c9ae62b2025-09-08WarningsExact identifier
application number: M012
PhysiciansCare Allergy Multi-Symptom ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEAcme United Corporationfd101c27-6ba9-4cd3-baec-a354504c37a02025-09-08WarningsExact identifier
application number: M012
Green Guard Honey Lemon Cough DropMENTHOL 8.6 MGUnifirst First Aid Corporation8a94f090-61d6-4909-e053-2995a90aee382025-09-08WarningsExact identifier
application number: M012
Green Guard Cough Drop ReliefMENTHOLUnifirst First Aid Corporation0fc4cb11-8ff9-4eff-9588-c73eef4e01372025-09-08WarningsExact identifier
application number: M012
Multi-Symptom Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,Unifirst First Aid Corporatione6ea6faf-baff-a130-e053-2a95a90a085a2025-09-08WarningsExact identifier
application number: M012
MEDIQUE Medikoff DropsMENTHOLUnifirst First Aid Corporation0d6b4443-16a1-4851-bb03-d7407167551d2025-09-08WarningsExact identifier
application number: M012
Medique Sugar Free Medikoff DropsMENTHOLUnifirst First Aid Corporation92d13e19-4e7b-4565-970e-504abf02579a2025-09-08WarningsExact identifier
application number: M012
Medique at Home DiphenDIPHENHYDRAMINE HCLUnifirst First Aid Corporationb56d1966-efd7-56eb-e053-2995a90a89b52025-09-08WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83033-1609-1830331609011 POUCH in 1 BOX (83033-1609-1) / 4 g in 1 POUCH1 pouch2023-11-01NoNoCurrent