DoloEar
- Product NDC
- 55758-506
- 11-digit product format
- 557580506
- Labeler code
- 55758
- Product ID
- 55758-506_4df01db0-dba9-6561-e063-6294a90a6d15
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Carbamide Peroxide
- Dosage form
- LIQUID
- Route
- AURICULAR (OTIC)
- Labeler
- Pharmadel LLC
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-15
- Substance
- CARBAMIDE PEROXIDE
- Active strength
- 6.5 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DoloEar
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMIDE PEROXIDE | 6.5 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 31PZ2VAU81 |
| Rxcui | 702050 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55758-506-01 | DoloEar | 1 in 1 CARTON | LIQUID | 1 | | 3 |
| 55758-506-01 | DoloEar | 15 mL in 1 BOTTLE, DROPPER | LIQUID | 15 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55758-506 | DOLOEAR (CARBAMIDE PEROXIDE) LIQUID [PHARMADEL LLC] | 1 | Current NDC, 2 package rows | 20250521_352df636-0469-c33e-e063-6294a90a2224.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55758-506-01 | 55758050601 | 1 BOTTLE, DROPPER in 1 CARTON (55758-506-01) / 15 mL in 1 BOTTLE, DROPPER | 2025-05-15 | No | No | Historical |