ProRinse Earwax Removal System
- Product NDC
- 66354-007
- 11-digit product format
- 663540007
- Labeler code
- 66354
- Product ID
- 66354-007_4a636cb5-104c-7811-e063-6294a90afcb0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CARBAMIDE PEROXIDE
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- McKeon Products Inc
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-02-05
- 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
- ProRinse Earwax Removal System
- 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66354-007-82 | ProRinse Earwax Removal System | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 1 |
| 66354-007-82 | ProRinse Earwax Removal System | 1 in 1 BOX | SOLUTION/ DROPS | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 66354-007-82 | 66354000782 | 1 BOTTLE in 1 BOX (66354-007-82) / 15 mL in 1 BOTTLE | 1 bottle | 2026-02-05 | No | No | Historical |