Oral Gel
- Product NDC
- 83650-101
- 11-digit product format
- 836500101
- Labeler code
- 83650
- Product ID
- 83650-101_299dca27-d254-e6ea-e063-6394a90a4f74
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine Benzalkonium Chloride
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Savvy Care and Cosmetics
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-09-22
- Substance
- BENZALKONIUM CHLORIDE; BENZOCAINE
- Active strength
- .1; 20 g/100g; g/100g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oral Gel
- Brand name suffix
- Oral Pain Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZALKONIUM CHLORIDE | .1 g/100g |
| BENZOCAINE | 20 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5UM2KM3W7, U3RSY48JW5 |
| Rxcui | 1595155 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83650-101-01 | Oral GelOral Pain Relief | 42.5 g in 1 TUBE | GEL | 42.5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83650-101 | ORAL GEL ORAL PAIN RELIEF (BENZOCAINE BENZALKONIUM CHLORIDE) GEL [SAVVY CARE AND COSMETICS] | 2 | Current NDC, 1 package rows | 20241222_05ede7e4-5a0a-c942-e063-6294a90a8a24.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83650-101-01 | 83650010101 | 42.5 g in 1 TUBE (83650-101-01) | 42.5 g | 2023-09-22 | No | No | Historical |