NDC 0187-5465

Caladryl

Ferric Oxide Red, Zinc Oxide, And Pramoxine Hydrochloride

Caladryl is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Valeant Pharmaceuticals North America Llc. The primary component is Ferric Oxide Red; Zinc Oxide; Pramoxine Hydrochloride.

• Product ID: 0187-5465_6338578b-9ad7-4090-b9d2-e9e93fca97ce
• NDC: 0187-5465
• Product Type: Human Otc Drug
• Proprietary Name: Caladryl
• Generic Name: Ferric Oxide Red, Zinc Oxide, And Pramoxine Hydrochloride
• 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: Valeant Pharmaceuticals North America LLC
• Substance Name: FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0187-5465-06

177 mL in 1 BOTTLE, PLASTIC (0187-5465-06)

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

NDC SPL Data Element Entries

NDC 0187-5465-06 [00187546506]

Caladryl LOTION

• Marketing Category: OTC monograph final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-08-16

Drug Details

Active Ingredients

Ingredient	Strength
FERRIC OXIDE RED	1.36 mg/mL

OpenFDA Data

• SPL SET ID: 67d4fd42-9fed-4238-9f5a-c9403abbcf20
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • 1K09F3G675
  • 88AYB867L5
  • SOI2LOH54Z
• RxNorm Concept Unique ID - RxCUI:
  • 1234533
  • 1234532

NDC Crossover Matching brand name "Caladryl" or generic name "Ferric Oxide Red, Zinc Oxide, And Pramoxine Hydrochloride"

NDC	Brand Name	Generic Name
0187-5465	Caladryl	Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride
58232-9911	Aveeno Calamine and Pramoxine Hydrochloride Anti Itch	Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride