NDC 49035-030

Calamine Plus

Ferric Oxide Red, Pramoxine Hydrochloride, Zinc Oxide

Calamine Plus is a Topical Aerosol, Spray in the Human Otc Drug category. It is labeled and distributed by Wal-mart Stores, Inc.. The primary component is Ferric Oxide Red; Pramoxine Hydrochloride; Zinc Oxide.

• Product ID: 49035-030_98cde0f1-8570-f006-e053-2a95a90a355b
• NDC: 49035-030
• Product Type: Human Otc Drug
• Proprietary Name: Calamine Plus
• Generic Name: Ferric Oxide Red, Pramoxine Hydrochloride, Zinc Oxide
• Dosage Form: Aerosol, Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-03-03
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Wal-Mart Stores, Inc.
• Substance Name: FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
• Active Ingredient Strength: 0 mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 49035-030-01

177 mL in 1 CANISTER (49035-030-01)

• Marketing Start Date: 2013-03-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49035-030-01 [49035003001]

Calamine Plus AEROSOL, SPRAY

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-03-03

Drug Details

Active Ingredients

Ingredient	Strength
FERRIC OXIDE RED	.345 mg/mL

OpenFDA Data

• SPL SET ID: eba4b13f-bc23-45d5-b01e-8ca10cdbb2cc
• Manufacturer:
  • Wal-Mart Stores, Inc.
• UNII:
  • 1K09F3G675
  • 88AYB867L5
  • SOI2LOH54Z

NDC Crossover Matching brand name "Calamine Plus" or generic name "Ferric Oxide Red, Pramoxine Hydrochloride, Zinc Oxide"

NDC	Brand Name	Generic Name
46122-745	Calamine Plus	Calamine Plus Pramoxine HCl
49035-030	Calamine Plus	FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE