NDC 63102-107

ACTISEP

Benzocaine, Menthol, Cetylpyridinium Chloride

ACTISEP is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Actipharma, Inc. The primary component is Benzocaine; Menthol, Unspecified Form; Cetylpyridinium Chloride.

• Product ID: 63102-107_c3b0081c-16a9-48ab-b91f-d1d1eb8d6f5d
• NDC: 63102-107
• Product Type: Human Otc Drug
• Proprietary Name: ACTISEP
• Generic Name: Benzocaine, Menthol, Cetylpyridinium Chloride
• Dosage Form: Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-12-28
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Actipharma, Inc
• Substance Name: BENZOCAINE; MENTHOL, UNSPECIFIED FORM; CETYLPYRIDINIUM CHLORIDE
• Active Ingredient Strength: 2 g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63102-107-01

30 mL in 1 BOTTLE, SPRAY (63102-107-01)

• Marketing Start Date: 2015-12-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63102-107-01 [63102010701]

ACTISEP SPRAY

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-12-28

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	2 g/100mL

OpenFDA Data

• SPL SET ID: d76c26fe-f970-4f4c-8e4a-4db8db3debb0
• Manufacturer:
  • Actipharma, Inc
• UNII:
  • U3RSY48JW5
  • L7T10EIP3A
  • D9OM4SK49P
• RxNorm Concept Unique ID - RxCUI:
  • 1426687
• UPC Code:
  • 0663102107017

NDC Crossover Matching brand name "ACTISEP" or generic name "Benzocaine, Menthol, Cetylpyridinium Chloride"

NDC	Brand Name	Generic Name
63102-106	ACTISEP	BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE
63102-107	ACTISEP	BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE
54859-503	Orasep	Benzocaine, Menthol, Cetylpyridinium Chloride
54859-504	Orasep	Benzocaine, Menthol, Cetylpyridinium Chloride