RAYO BREATH MENTHOL
- Product NDC
- 83033-1605
- 11-digit product format
- 830331605
- Labeler code
- 83033
- Product ID
- 83033-1605_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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 83033-1605-1 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 83033-1605-1 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 83033-1605-1 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 83033-1605-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 83033-1605-1 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 83033-1605-1 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 83033-1605-1 | U | Excluded because listing certification expired | 0efc9e666f02… | 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 BREATH MENTHOL
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 1 g/g |
| CAMPHOR (SYNTHETIC) | 1 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| LAV5U5022Y | Internal UNII lookup |
| 5TJD82A1ET | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 09e4a36b-020a-c5b1-e063-6394a90a3e31 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83033-1605-1 | 2025-05-02 | C162847 | 48780-1 | 2cef2736-a143-d83d-e063-dadaa90ab31f | 09e4a36b-020a-c5b1-e063-6394a90a3e31 |
| 83033-1605-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a143-d83d-e063-dadaa90ab31f | 09e4a36b-020a-c5b1-e063-6394a90a3e31 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83033-1605-1 | RAYO BREATH MENTHOL | 50 g in 1 TUBE | CREAM | 50 | 3 | |
| 83033-1605-1 | RAYO BREATH MENTHOL | 1 in 1 BOX | CREAM | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83033-1605 | RAYO 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] | 2 | Current NDC, 2 package rows | 20250504_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 7dc3941a-e5f8-4caa-bae5-6a0d075295cb | 2024-11-01 | Warnings | M012 |
| DoloMax Cold Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | BENARD INDUSTRIES INC | 520aee75-8b9a-4dcc-8970-75e122640e91 | 2024-10-31 | Warnings | M012 |
| Good Sense Nasal | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe | 2024-10-31 | Warnings | M012 |
| CareOne Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | American Sales Company | 819d5c82-0240-4013-9904-c335bd65d03e | 2024-10-30 | Warnings | M012 |
| Signature Care Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway | 9a0ad5d5-8fd9-468d-be2c-87c14d08b934 | 2024-10-30 | Warnings | M012 |
| Good Sense Severe NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | L. Perrigo Company | f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 | 2024-10-30 | Warnings | M012 |
| dg health cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Dolgencorp, LLC | 81f3ac36-9bae-4f42-92a0-8a2e4bbd0984 | 2024-10-30 | Warnings | M012 |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Rite Aid Corporation | 9a71e8eb-4195-4694-bf3e-44f691ff2cef | 2024-10-30 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | H E B | fe4a95d2-6fb3-43fe-baec-6f22d1965323 | 2024-10-30 | Warnings | M012 |
| NightTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger Company | 2c9ef0d7-3d5b-494a-8f06-9dd42110d78a | 2024-10-30 | Warnings | M012 |
| Severe Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | d40d6fd1-3f84-40ae-ab7e-04569eb41617 | 2024-10-30 | Warnings | M012 |
| equaline nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 4e0c6ad6-81ef-4b0e-b2eb-44256faf7358 | 2024-10-30 | Warnings | M012 |
| GOOD REMEDIES Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 24fbe2c0-7749-4c8a-e063-6394a90a7c6e | 2024-10-30 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 130e68d1-9048-49c1-beee-490eecaed2d9 | 2024-10-30 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 02f3e739-3153-412f-b2cd-6f01dcd5875b | 2024-10-30 | Warnings | M012 |
| HealthWise Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | 25a19d3e-37b3-50d5-e063-6394a90a97d1 | 2024-10-29 | Warnings | M012 |
| Antigrip Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Pharmadel LLC | 25a23a03-6110-f595-e063-6394a90a70fe | 2024-10-29 | Warnings | M012 |
| Antigrip Cough and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Pharmadel LLC | 25a23e5e-302a-7b7f-e063-6294a90a0463 | 2024-10-29 | Warnings | M012 |
| Antigrip Extra Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Pharmadel LLC | 25a26adf-fd90-bf57-e063-6294a90a4073 | 2024-10-29 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | e82dac83-2910-44dc-e053-2995a90a38e1 | 2024-10-29 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83033-1605-1 | 83033160501 | 1 TUBE in 1 BOX (83033-1605-1) / 50 g in 1 TUBE | 1 tube | 2023-11-01 | No | No | Current |