NDC 54723-997

Comfortox Tetracaine

Tetracaine Hcl

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 ID: 54723-997_48e9e6f3-60e6-40d5-91ef-fcc1af94e9b9
• NDC: 54723-997
• Product Type: Human Otc Drug
• Proprietary Name: Comfortox Tetracaine
• Generic Name: Tetracaine Hcl
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-09-14
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Sambria Pharmaceuticals, Inc.
• Substance Name: TETRACAINE HYDROCHLORIDE
• Active Ingredient Strength: 20 mg/1000mg
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54723-997-01

1500 mg in 1 PACKET (54723-997-01)

• Marketing Start Date: 2016-09-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54723-997-01 [54723099701]

Comfortox Tetracaine CREAM

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-09-14

Drug Details

Active Ingredients

Ingredient	Strength
TETRACAINE HYDROCHLORIDE	20 mg/1000mg

OpenFDA Data

• SPL SET ID: 90f644b4-faa2-4f54-865a-44ccdab99ad3
• Manufacturer:
  • Sambria Pharmaceuticals, Inc.
• UNII:
  • 5NF5D4OPCI
• RxNorm Concept Unique ID - RxCUI:
  • 1543158

NDC Crossover Matching brand name "Comfortox Tetracaine" or generic name "Tetracaine Hcl"

NDC	Brand Name	Generic Name
54723-997	Comfortox Tetracaine	Tetracaine HCL
54723-669	Eclipse Topical Analgesic	Tetracaine HCL
54723-310	NeuroMed Topical Analgesic	Tetracaine HCL
54723-725	Pain Prescriptives Topical Analgesic	Tetracaine HCL
54723-237	Plush anesthetics	Tetracaine HCL
17478-045	Tetracaine	Tetracaine HCl
54288-127	Tetracaine HCL	Tetracaine HCL