Freskaro Earwax Removal Aid
- Product NDC
- 82645-097
- 11-digit product format
- 826450097
- Labeler code
- 82645
- Product ID
- 82645-097_4f86b363-aff6-1bfb-e063-6394a90a317f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- carbamide peroxide 6.50% kit
- Dosage form
- LIQUID
- Route
- AURICULAR (OTIC)
- Labeler
- Pharma Nobis, LLC
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-13
- 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
- Freskaro Earwax Removal Aid
- 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 |
|---|
| 82645-097-45 | Freskaro Earwax Removal Aid | 1 in 1 CARTON | LIQUID | 1 | | 2 |
| 82645-097-45 | Freskaro Earwax Removal Aid | 15 mL in 1 BOTTLE, DROPPER | LIQUID | 15 | | 2 |
| 82645-097-90 | Freskaro Earwax Removal Aid | 1 in 1 CARTON | LIQUID | 1 | | 2 |
| 82645-097-90 | Freskaro Earwax Removal Aid | 15 mL in 1 BOTTLE, DROPPER | LIQUID | 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 |
|---|
| 82645-097-45 | 82645009745 | 1 BOTTLE, DROPPER in 1 CARTON (82645-097-45) / 15 mL in 1 BOTTLE, DROPPER | 2026-04-15 | No | No | Historical |
| 82645-097-90 | 82645009790 | 1 BOTTLE, DROPPER in 1 CARTON (82645-097-90) / 15 mL in 1 BOTTLE, DROPPER | 2026-04-13 | No | No | Historical |