DycloPro
- Product NDC
- 0362-3971
- 11-digit product format
- 003623971
- Labeler code
- 0362
- Product ID
- 0362-3971_639ddf01-a839-45be-b9a7-11f27394c799
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dyclonine Hydrochloride
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Septodont Inc
- Application
- ANDA200480
- Marketing category
- ANDA
- Marketing start
- 2019-09-01
- Substance
- DYCLONINE HYDROCHLORIDE
- Active strength
- 5 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
- DycloPro
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DYCLONINE HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZEC193879Q |
| Rxcui | 1048281, 2199132 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0362-3971-05 | DycloPro | 1 in 1 BOTTLE | SOLUTION | 1 | | 5 |
| 0362-3971-05 | DycloPro | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0362-3971 | DYCLOPRO (DYCLONINE HYDROCHLORIDE) SOLUTION [SEPTODONT INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241130_bfd9a2dd-7b40-40c0-b256-52f613395760.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 |
|---|
| 0362-3971-05 | 00362397105 | 1 BOTTLE in 1 BOTTLE (0362-3971-05) / 30 mL in 1 BOTTLE | 1 bottle | 2019-09-01 | 0000-00-00 | No | No | Current |