Onral Oral Pain Reliever Mouthwash
- Product NDC
- 85454-0421
- 11-digit product format
- 854540421
- Labeler code
- 85454
- Product ID
- 85454-0421_36b1704e-640d-bab5-e063-6394a90a4145
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BENZOCAINE
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Syka Pharma Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-01
- Substance
- BENZOCAINE
- Active strength
- 50 mg/mL
- 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
- Onral Oral Pain Reliever Mouthwash
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOCAINE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3RSY48JW5 |
| Rxcui | 2717653 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85454-0421-1 | Onral Oral Pain Reliever Mouthwash | 1 in 1 CARTON | LIQUID | 1 | | 1 |
| 85454-0421-1 | Onral Oral Pain Reliever Mouthwash | 230 mL in 1 BOTTLE, PLASTIC | LIQUID | 230 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85454-0421-1 | 85454042101 | 1 BOTTLE, PLASTIC in 1 CARTON (85454-0421-1) / 230 mL in 1 BOTTLE, PLASTIC | 2025-07-01 | No | No | Current |