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 |
|---|---|---|---|---|---|---|
| NICE Honey Lemon Cough Drops | MENTHOL | Leosons Overseas Corp | 96da2c9d-2d0d-6252-e053-2995a90ac338 | 2024-11-19 | Warnings | M012 |
| SanaTos Boost | DEXTROMETHORPHAN HBR | Pharmadel LLC | ae6a424f-f3f0-3f6c-e053-2995a90a972d | 2024-11-18 | Warnings | M012 |
| SanaTos Turbo Max Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Pharmadel LLC | d56a071c-a747-5397-e053-2995a90aad8b | 2024-11-18 | Warnings | M012 |
| equaline childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | a24021a0-ef68-4bce-ba53-d262d1025cc0 | 2024-11-17 | Warnings | M012 |
| Cold and Cough DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | 4d5f93c1-7752-4948-ba58-c4385cfc24c8 | 2024-11-17 | Warnings | M012 |
| Good Sense Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 8a87104f-94a4-4585-afd5-d610eea32e39 | 2024-11-17 | Warnings | M012 |
| equate childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | c91e94f4-4c51-4fe7-ad2e-0b9dc58b51e4 | 2024-11-17 | Warnings | M012 |
| foster and thrive childrens allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 1eac715b-351c-4b47-8d1d-6e921813c1a4 | 2024-11-15 | Warnings | M012 |
| basic care daytime severe cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 2024-11-15 | Warnings | M012 |
| dg health day time severe cold and flu relief night time severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Dolgencorp, LLC | f721b393-9ad5-4fc6-a2c5-bd89e58caf16 | 2024-11-15 | Warnings | M012 |
| basic care daytime severe cold and flu nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2 | 2024-11-15 | Warnings | M012 |
| Rompe Pecho EX | GUAIFENESIN | Efficient Laboratories Inc | 89ea23a5-0da7-407e-83d9-77a0b562f3af | 2024-11-14 | Warnings | M012 |
| basic care daytime cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | ceb342da-ff6d-4c19-9f78-0033d028075e | 2024-11-14 | Warnings | M012 |
| Topcare Nite Time Day Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates LLC | efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 2024-11-14 | Warnings | M012 |
| good neighbor pharmacy nasal four | PHENYLEPHRINE HYDROCHLORIDE | Amerisource Bergen | a3d637dc-d957-458c-8a75-f948601a31aa | 2024-11-14 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Meijer Distribution Inc | ec8db98f-4fd1-4644-b76f-ff04f72e87f4 | 2024-11-13 | Warnings | M012 |
| dg health tussin | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp, LLC | 6f9b8267-1e0b-430b-8e44-06408ae82ea4 | 2024-11-13 | Warnings | M012 |
| Walgreens Effervescent Cold Relief Plus | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Walgreens | b60e2cf9-11ec-469e-e053-2a95a90a712a | 2024-11-13 | Warnings | M012 |
| Kroger Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Kroger Company | 69333774-3cf4-384d-e053-2a91aa0a48b3 | 2024-11-13 | Warnings | M012 |
| Effervescent Orange Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | H. E. Butt Grocery Company | 6403fe3d-d82b-f4d5-e053-2991aa0ac7d6 | 2024-11-13 | 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 |