ear drops
- Product NDC
- 69452-377
- 11-digit product format
- 694520377
- Labeler code
- 69452
- Product ID
- 69452-377_507543ad-0cd9-75be-e063-6394a90aee95
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Carbamide Peroxide 6.5%
- Dosage form
- LIQUID
- Route
- AURICULAR (OTIC)
- Labeler
- Bionpharma Inc.
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-09-15
- Substance
- CARBAMIDE PEROXIDE
- Active strength
- .065 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
- ear drops
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMIDE PEROXIDE | .065 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 |
|---|
| 69452-377-75 | ear drops | 15 mL in 1 BOTTLE, DROPPER | LIQUID | 15 | | 4 |
| 69452-377-75 | ear drops | 1 in 1 CARTON | LIQUID | 1 | | 4 |
| 69452-377-95 | ear drops | 15 mL in 1 BOTTLE, DROPPER | LIQUID | 15 | | 4 |
| 69452-377-95 | ear drops | 2 in 1 CARTON | LIQUID | 2 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-377 | EAR DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [BIONPHARMA INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241225_e8bcf92c-ad32-49d5-e053-2995a90ae0c6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69452-377-75 | 69452037775 | 1 BOTTLE, DROPPER in 1 CARTON (69452-377-75) / 15 mL in 1 BOTTLE, DROPPER | 2022-09-15 | | No | No | Current |
| 69452-377-95 | 69452037795 | 2 BOTTLE, DROPPER in 1 CARTON (69452-377-95) / 15 mL in 1 BOTTLE, DROPPER | 2022-09-15 | 0000-00-00 | No | No | Current |