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.
| 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 | 83033-1609-1 | 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 | 83033-1609-1 | 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 | 83033-1609-1 | 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 | 83033-1609-1 | 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 | 83033-1609-1 | 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 | 83033-1609-1 | 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 | 83033-1609-1 | 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 ACTIVE ICE SACHET
- 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 |
|---|---|
| 5TJD82A1ET | Internal UNII lookup |
| LAV5U5022Y | 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 |
|---|---|---|---|---|---|
| 83033-1609-1 | 2025-05-02 | C162847 | 48780-1 | 2cef2736-a143-d83d-e063-dadaa90ab31f | 09e4a36b-020a-c5b1-e063-6394a90a3e31 |
| 83033-1609-1 | 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 |
|---|---|---|---|---|---|---|
| 83033-1609-1 | RAYO ACTIVE ICE SACHET | 4 g in 1 POUCH | CREAM | 4 | 3 | |
| 83033-1609-1 | RAYO ACTIVE ICE SACHET | 1 in 1 BOX | CREAM | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83033-1609 | 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 |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 20ae92d9-fbc6-5b7a-e063-6294a90a15c3 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51c44970-06e5-082e-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 54236151-37db-0b5a-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 52542774-fd05-640c-e054-00144ff8d46c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51dca689-e4a0-5526-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6f2d18f6-935f-9215-e053-2a91aa0aedd3 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6fb28fa1-ebbb-64bf-e053-2991aa0a1de4 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5213ca7f-5a78-6471-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6f7ba256-ed14-5fe0-e053-2a91aa0aacc1 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 6f7bf92d-4aaf-86e0-e053-2991aa0a2d91 | 2025-12-04 | Warnings | M012 |
| Afrin NoDrip Allergy Sinus Night | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | b023a571-7e54-7c63-e053-2a95a90a0f78 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Cough and Cold | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE | Bayer HealthCare LLC. | b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d | 2025-12-04 | Warnings | M012 |
| Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | e3231869-8ddf-9d17-e053-2995a90ae6d5 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Multi Symptom Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | ae7cf41e-b618-d6bb-e053-2a95a90a6692 | 2025-12-04 | Warnings | M012 |
| Afrin Allergy Sinus Nasal | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | c2d903bf-5c51-82d7-e053-2995a90aea49 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Cold, Cough and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 351d3c5c-05c8-921a-e063-6394a90abef9 | 2025-12-04 | Warnings | M012 |
| Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | e3b239bd-ffc7-600c-e053-2a95a90a3b3b | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Cold Flu And Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Bayer HealthCare LLC. | de95d2dd-e766-f7ec-e053-2995a90afc5f | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Cold and Flu Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | e4f3f906-2252-21d1-e053-2a95a90a85df | 2025-12-04 | Warnings | M012 |
| Afrin No Drip Pump Mist Bundle Pack | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | 16c52c79-baec-87db-e063-6294a90a3b3b | 2025-12-04 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83033-1609-1 | 83033160901 | 1 POUCH in 1 BOX (83033-1609-1) / 4 g in 1 POUCH | 1 pouch | 2023-11-01 | No | No | Current |