Prime-Gel
- Product NDC
- 77794-018
- Requested package NDC
- 77794-018-17
- 11-digit product format
- 777940018
- Labeler code
- 77794
- Product ID
- 77794-018_c133c7ce-0a1b-5d8b-e053-2a95a90a5dc6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- DENTAL; ORAL; PERIODONTAL
- Labeler
- Prime Dental Manufacturing, Inc.
- Application
- part356
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2020-12-15
- Marketing end
- 0000-00-00
- Substance
- BENZOCAINE
- Active strength
- 0 g/g
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 77794-018-00 | Prime-Gel | 24 in 1 BOX, UNIT-DOSE | GEL | 24 | | 3 |
| 77794-018-17 | Prime-Gel | 29.6 g in 1 BOTTLE | GEL | 29.6 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 77794-018 | PRIME-GEL (BENZOCAINE) GEL [PRIME DENTAL MANUFACTURING, INC.] | 2 | Legacy NDC, 2 package rows | 20210501_ab6ef479-2567-0cf2-e053-2a95a90a272a.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 |
|---|
| 77794-018-17 | 77794001817 | 29.6 g in 1 BOTTLE (77794-018-17) | 29.6 g | 2020-12-15 | 0000-00-00 | No | No | Current |