NDC 0187-5466

Caladryl Clear

Pramoxine Hydrochloride And Zinc Acetate

Caladryl Clear is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Pramoxine Hydrochloride; Zinc Acetate.

• Product ID: 0187-5466_1917a021-66c3-457d-b427-82f6e9795dbd
• NDC: 0187-5466
• Product Type: Human Otc Drug
• Proprietary Name: Caladryl Clear
• Generic Name: Pramoxine Hydrochloride And Zinc Acetate
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-08-16
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part347
• Labeler Name: Bausch Health US, LLC
• Substance Name: PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
• Active Ingredient Strength: 10 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0187-5466-06

177 mL in 1 BOTTLE, PLASTIC (0187-5466-06)

• Marketing Start Date: 2013-08-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-5466-06 [00187546606]

Caladryl Clear LOTION

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-08-16
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: fca6f08b-7fa0-4ae6-bce3-61f3bcae4332
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • 88AYB867L5
  • FM5526K07A
• RxNorm Concept Unique ID - RxCUI:
  • 1234546
  • 1234552
• UPC Code:
  • 0301875466060

NDC Crossover Matching brand name "Caladryl Clear" or generic name "Pramoxine Hydrochloride And Zinc Acetate"

NDC	Brand Name	Generic Name
0187-5466	Caladryl Clear	PRAMOXINE HYDROCHLORIDE and ZINC ACETATE
0395-9108	Calaclear	Pramoxine Hydrochloride and Zinc Acetate
49035-402	Calaclear	Pramoxine Hydrochloride and Zinc Acetate
82645-923	Calaclear	Pramoxine Hydrochloride and Zinc Acetate
24385-439	Caldyphen Clear	Pramoxine Hydrochloride and Zinc acetate
69842-400	CVS Itch Relief	Pramoxine Hydrochloride and Zinc Acetate
0395-0400	Humco Calaclear	Pramoxine Hydrochloride and Zinc Acetate