Earwax Removal Drops
- Product NDC
- 0395-9133
- 11-digit product format
- 003959133
- Labeler code
- 0395
- Product ID
- 0395-9133_0c93a2f8-8199-15fb-e063-6394a90a5521
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Carbamide Peroxide 6.5%
- Dosage form
- LIQUID
- Route
- AURICULAR (OTIC)
- Labeler
- Humco Holding Group, Inc
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-06-04
- Substance
- CARBAMIDE PEROXIDE
- Active strength
- .065 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Earwax Removal Drops
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMIDE PEROXIDE | .065 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 31PZ2VAU81 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0395-9133-45 | Earwax Removal Drops | 1 in 1 CARTON | LIQUID | 1 | | 5 |
| 0395-9133-45 | Earwax Removal Drops | 15 mL in 1 BOTTLE, DROPPER | LIQUID | 15 | | 5 |
| 0395-9133-90 | Earwax Removal Drops | 15 mL in 1 CONTAINER | LIQUID | 15 | | 5 |
| 0395-9133-90 | Earwax Removal Drops | 1 in 1 CARTON | LIQUID | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0395-9133 | EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [HUMCO HOLDING GROUP, INC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20231216_a8c052d8-fb9c-09f2-e053-2a95a90a37af.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0395-9133-45 | 00395913345 | 1 BOTTLE, DROPPER in 1 CARTON (0395-9133-45) / 15 mL in 1 BOTTLE, DROPPER | | 2019-06-04 | 0000-00-00 | No | No | Current |
| 0395-9133-90 | 00395913390 | 1 CONTAINER in 1 CARTON (0395-9133-90) / 15 mL in 1 CONTAINER | 1 container | 2019-06-04 | 0000-00-00 | No | No | Current |