NDC 55315-413

Freds Calamine

Calamine 8% And Zinc Oxide 8%

Freds Calamine is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Fred's, Inc.. The primary component is Zinc Oxide.

• Product ID: 55315-413_5df489e4-d619-66fa-e053-2991aa0a88cc
• NDC: 55315-413
• Product Type: Human Otc Drug
• Proprietary Name: Freds Calamine
• Generic Name: Calamine 8% And Zinc Oxide 8%
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 1998-03-25
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part347
• Labeler Name: Fred's, Inc.
• Substance Name: ZINC OXIDE
• Active Ingredient Strength: 160 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55315-413-96

177 mL in 1 BOTTLE, PLASTIC (55315-413-96)

• Marketing Start Date: 2017-11-13
• Marketing End Date: 2024-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55315-413-96 [55315041396]

Freds Calamine LOTION

• Marketing Category: OTC monograph final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-11-13

Drug Details

Active Ingredients

Ingredient	Strength
ZINC OXIDE	160 mg/mL

OpenFDA Data

• SPL SET ID: 5df48f74-ea90-9a01-e053-2a91aa0a7d3b
• Manufacturer:
  • Fred's, Inc.
• UNII:
  • SOI2LOH54Z
• RxNorm Concept Unique ID - RxCUI:
  • 199109
• UPC Code:
  • 0084579118762

NDC Crossover Matching brand name "Freds Calamine" or generic name "Calamine 8% And Zinc Oxide 8%"

NDC	Brand Name	Generic Name
55315-413	Freds Calamine	Calamine 8% and Zinc Oxide 8%
33992-4130	Assured Calamine	Calamine 8% and Zinc Oxide 8%
0395-9110	Calamine	Calamine 8% and Zinc Oxide 8%
45591-041	Calamine	Calamine 8% and Zinc Oxide 8%
82645-900	Calamine	Calamine 8% and Zinc Oxide 8%
53943-413	DDM Calamine	Calamine 8% and Zinc Oxide 8%
24385-413	GNP Calamine Topical Suspension	Calamine 8% and Zinc Oxide 8%
64092-413	Health Care Calamine	Calamine 8% and Zinc Oxide 8%
62011-0114	Health Mart Calamine	Calamine 8% and Zinc Oxide 8%
0395-0413	Humco Calamine	Calamine 8% and Zinc Oxide 8%
68016-413	Premiere Value Calamine	Calamine 8% and Zinc Oxide 8%
63868-317	Quality Choice Calamine	Calamine 8% and Zinc Oxide 8%
11822-4352	Rite Aid Calamine	Calamine 8% and Zinc Oxide 8%
15127-413	Select Brand Calamine	Calamine 8% and Zinc Oxide 8%
49348-011	Sunmark Calamine	Calamine 8% and Zinc Oxide 8%