Otix Ear wax Removal Drops
- Product NDC
- 15579-838
- 11-digit product format
- 155790838
- Labeler code
- 15579
- Product ID
- 15579-838_0c7fd25e-6acd-1a54-e063-6294a90af27d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CARBAMIDE PEROXIDE
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Bell Pharmaceuticals, Inc.
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-10-01
- Substance
- CARBAMIDE PEROXIDE
- Active strength
- 65 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
- Otix Ear wax Removal Drops
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMIDE PEROXIDE | 65 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 31PZ2VAU81 |
| Rxcui | 702050, 2588948 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 15579-838-34 | Otix Ear wax Removal System Ear wax and Bulb | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 mL | 65 mg in 1mL | 2 |
| 15579-838-34 | Otix Ear wax Removal System Ear wax and Bulb | 1 in 1 BOX | SOLUTION/ DROPS | | 65 mg in 1mL | 2 |
| 15579-838-34 | Otix Ear wax Removal Drops | 1 in 1 BOX | SOLUTION/ DROPS | 1 | | 2 |
| 15579-838-34 | Otix Ear wax Removal Drops | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 15579-838 | OTIX EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [BELL PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20231216_0e70ab09-9360-4ab6-a1fe-6f82af392581.zip |
| 15579-838 | OTIX EAR WAX REMOVAL SYSTEM EAR WAX AND BULB (CARBAMIDE PEROXIDE) KIT [BELL PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC | 20231219_15868798-28cd-4495-9baf-711e81ad8bdd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 15579-838-34 | 15579083834 | 1 BOTTLE in 1 BOX (15579-838-34) / 15 mL in 1 BOTTLE | 1 bottle | 2021-10-01 | 0000-00-00 | No | No | Current |