Americaine
- Product NDC
- 63736-375
- 11-digit product format
- 637360375
- Labeler code
- 63736
- Product ID
- 63736-375_41746b33-0ff3-4b02-8018-34e4fd54ef7b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Insight Pharmaceuticals LLC
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-07-10
- Substance
- BENZOCAINE
- Active strength
- 5.6 g/28g
- 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
- Americaine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOCAINE | 5.6 g/28g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3RSY48JW5 |
| Rxcui | 244557, 1426293 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63736-375-01 | Americaine | 28 g in 1 TUBE | OINTMENT | 28 | | 6 |
| 63736-375-01 | Americaine | 1 in 1 BOX | OINTMENT | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63736-375 | AMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241129_d13c022f-2f91-40b4-bd66-0cfc0e147a5f.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 |
|---|
| 63736-375-01 | 63736037501 | 1 TUBE in 1 BOX (63736-375-01) / 28 g in 1 TUBE | 1 tube | 2009-07-10 | 0000-00-00 | No | No | Current |