Comfortox Tetracaine
- Product NDC
- 54723-997
- 11-digit product format
- 547230997
- Labeler code
- 54723
- Product ID
- 54723-997_59f03f28-def6-4e34-bac7-77d5cbc5c8dd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tetracaine HCL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sambria Pharmaceuticals, Inc.
- Application
- part348
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2016-09-14
- Marketing end
- 0000-00-00
- Substance
- TETRACAINE HYDROCHLORIDE
- Active strength
- 20 mg/1000mg
- Pharmacologic classes
- Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54723-997-01 | Comfortox Tetracaine | 1500 mg in 1 PACKET | CREAM | 1500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54723-997 | COMFORTOX TETRACAINE (TETRACAINE HCL) CREAM [SAMBRIA PHARMACEUTICALS, INC.] | 6 | Legacy NDC, 1 package rows | 20231202_90f644b4-faa2-4f54-865a-44ccdab99ad3.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 |
|---|
| 54723-997-01 | 54723099701 | 1500 mg in 1 PACKET (54723-997-01) | 1500 mg | 2016-09-14 | 0000-00-00 | No | No | Current |