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NDC 54723-0997-01 Comfortox Tetracaine 20 mg/1000mg Details
Comfortox Tetracaine 20 mg/1000mg
Comfortox Tetracaine is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Sambria Pharmaceuticals, Inc.. The primary component is TETRACAINE HYDROCHLORIDE.
Product Information
NDC | 54723-0997 |
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Product ID | 54723-997_094099ac-1a05-7d6b-e063-6394a90a936b |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Comfortox Tetracaine |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Tetracaine HCL |
Product Type | HUMAN OTC DRUG |
Dosage Form | CREAM |
Route | TOPICAL |
Active Ingredient Strength | 20 |
Active Ingredient Units | mg/1000mg |
Substance Name | TETRACAINE HYDROCHLORIDE |
Labeler Name | Sambria Pharmaceuticals, Inc. |
Pharmaceutical Class | Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH DRUG |
Application Number | M017 |
Listing Certified Through | 2024-12-31 |
Package
NDC 54723-0997-01 (54723099701)
NDC Package Code | 54723-997-01 |
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Billing NDC | 54723099701 |
Package | 1500 mg in 1 PACKET (54723-997-01) |
Marketing Start Date | 2016-09-14 |
NDC Exclude Flag | N |
Pricing Information | N/A |