Benzocaine 20%
- Product NDC
- 0121-1077
- 11-digit product format
- 001211077
- Labeler code
- 0121
- Product ID
- 0121-1077_83139f6d-1d4d-47d5-8da5-5dad5b9fe3b7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine 20%
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-03-20
- Substance
- BENZOCAINE
- Active strength
- 200 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benzocaine 20%
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOCAINE | 200 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3RSY48JW5 |
| Rxcui | 308657 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-1077-01 | Benzocaine 20% | 1 in 1 POUCH | SOLUTION | 1 | | 4 |
| 0121-1077-01 | Benzocaine 20% | 0.5 mL in 1 APPLICATOR | SOLUTION | 0.5 | | 4 |
| 0121-1077-25 | Benzocaine 20% | 25 in 1 CARTON | SOLUTION | 25 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0121-1077-01 | 00121107701 | 1 in 1 POUCH | | | | | Historical |
| 0121-1077-25 | 00121107725 | 25 POUCH in 1 CARTON (0121-1077-25) / 1 APPLICATOR in 1 POUCH (0121-1077-01) / .5 mL in 1 APPLICATOR | 25 pouch | 2026-03-20 | No | No | Current |