ORAL PAIN RELIEF
- Product NDC
- 52000-443
- 11-digit product format
- 520000443
- Labeler code
- 52000
- Product ID
- 52000-443_804b78cd-d8a1-4548-807c-75bd7c52009d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- ORAL
- Labeler
- Universal Distribution Center LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-01-20
- Substance
- BENZOCAINE
- Active strength
- 20 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ORAL PAIN RELIEF
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOCAINE | 20 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3RSY48JW5 |
| Rxcui | 238910 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52000-443-04 | ORAL PAIN RELIEF | 1 in 1 BOX | GEL | 1 | | 1 |
| 52000-443-04 | ORAL PAIN RELIEF | 11.9 g in 1 TUBE | GEL | 11.9 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 52000-443-04 | 52000044304 | 1 TUBE in 1 BOX (52000-443-04) / 11.9 g in 1 TUBE | 1 tube | 2026-01-20 | No | No | Historical |