Carbamide peroxide 6.5%
- Product NDC
- 69168-488
- 11-digit product format
- 691680488
- Labeler code
- 69168
- Product ID
- 69168-488_4f1c9234-6bb1-4795-af84-731f628424db
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Earwax Removal Kit
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Allegiant Health
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-28
- Substance
- CARBAMIDE PEROXIDE
- Active strength
- 65 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carbamide peroxide 6.5%
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMIDE PEROXIDE | 65 mg/mL |
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 |
|---|
| 69168-488-68 | Carbamide peroxide 6.5% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 2 |
| 69168-488-68 | Carbamide peroxide 6.5% | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69168-488-68 | 69168048868 | 1 BOTTLE, DROPPER in 1 CARTON (69168-488-68) / 15 mL in 1 BOTTLE, DROPPER | 2025-10-28 | No | No | Historical |