NDC 0295-9029

PainBloc

Capsaicin 0.25%

PainBloc is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Denison Pharmaceuticals, Llc. The primary component is Capsaicin.

• Product ID: 0295-9029_a06dc54e-250a-7036-e053-2995a90a5603
• NDC: 0295-9029
• Product Type: Human Otc Drug
• Proprietary Name: PainBloc
• Generic Name: Capsaicin 0.25%
• Dosage Form: Liquid
• Route of Administration: TOPICAL
• Marketing Start Date: 2020-03-09
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Denison Pharmaceuticals, LLC
• Substance Name: CAPSAICIN
• Active Ingredient Strength: 3 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0295-9029-60

1 BOTTLE, WITH APPLICATOR in 1 CARTON (0295-9029-60) > 12 mL in 1 BOTTLE, WITH APPLICATOR

• Marketing Start Date: 2020-03-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0295-9029-60 [00295902960]

PainBloc LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-03-09

Drug Details

Active Ingredients

Ingredient	Strength
CAPSAICIN	2.5 mg/mL

OpenFDA Data

• SPL SET ID: a06dc1dc-7646-e2b8-e053-2a95a90a9268
• Manufacturer:
  • Denison Pharmaceuticals, LLC
• UNII:
  • S07O44R1ZM
• RxNorm Concept Unique ID - RxCUI:
  • 1874747

NDC Crossover Matching brand name "PainBloc" or generic name "Capsaicin 0.25%"

NDC	Brand Name	Generic Name
0295-9029	PainBloc	Capsaicin 0.25%
0295-9034	PainBloc	Capsaicin 0.25%
71226-001	PainBloc24	Capsaicin 0.25%