Cold Relief Menthol
- Product NDC
- 53499-6272
- Requested package NDC
- 53499-6272-5
- 11-digit product format
- 534996272
- Labeler code
- 53499
- Product ID
- 53499-6272_52a16d52-6404-4d8b-bbd6-1a741d644956
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pelargonium sidoides
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Schwabe North America, Inc
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2025-01-17
- Substance
- PELARGONIUM SIDOIDES ROOT
- Active strength
- 1 [hp_X]/120mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Cold Relief Menthol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PELARGONIUM SIDOIDES ROOT | 1 [hp_X]/120mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53499-6272-5 | Cold Relief Menthol | 120 mL in 1 BOTTLE, PLASTIC | SYRUP | 120 | | 2 |
| 53499-6272-5 | Cold Relief Menthol | 1 in 1 CARTON | SYRUP | 1 | | 2 |
| 53499-6272-9 | Cold Relief Menthol | 240 mL in 1 BOTTLE, PLASTIC | SYRUP | 240 | | 2 |
| 53499-6272-9 | Cold Relief Menthol | 1 in 1 CARTON | SYRUP | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53499-6272 | COLD RELIEF MENTHOL (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC] | 1 | Current NDC, 4 package rows | 20250119_3c325ede-cc55-4e07-a8d1-d1acfb3c885f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 53499-6272-5 | 53499627205 | 1 BOTTLE, PLASTIC in 1 CARTON (53499-6272-5) / 120 mL in 1 BOTTLE, PLASTIC | 2025-01-17 | No | No | Current |