NDC 16864-240

Domeboro

Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate

Domeboro is a Topical Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Advantice Health, Llc.. The primary component is Aluminum Sulfate Tetradecahydrate; Calcium Acetate Monohydrate.

• Product ID: 16864-240_79c5f8f8-a76b-4838-afe4-19f85c4d786a
• NDC: 16864-240
• Product Type: Human Otc Drug
• Proprietary Name: Domeboro
• Generic Name: Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate
• Dosage Form: Powder, For Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-06-26
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part347
• Labeler Name: Advantice Health, LLC.
• Substance Name: ALUMINUM SULFATE TETRADECAHYDRATE; CALCIUM ACETATE MONOHYDRATE
• Active Ingredient Strength: 1347 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 16864-240-01

12 POWDER, FOR SOLUTION in 1 BOX (16864-240-01)

• Marketing Start Date: 2012-06-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16864-240-14 [16864024014]

Domeboro POWDER, FOR SOLUTION

• Marketing Category: OTC monograph not final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-06-26
• Marketing End Date: 2018-07-31

NDC 16864-240-01 [16864024001]

Domeboro POWDER, FOR SOLUTION

• Marketing Category: OTC monograph not final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-06-26

NDC 16864-240-10 [16864024010]

Domeboro POWDER, FOR SOLUTION

• Marketing Category: OTC monograph not final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-06-26
• Marketing End Date: 2017-04-30

Drug Details

Active Ingredients

Ingredient	Strength
ALUMINUM SULFATE TETRADECAHYDRATE	1347 mg/1

OpenFDA Data

• SPL SET ID: 28c39200-2f7c-954b-3ce7-7349b2738812
• Manufacturer:
  • MOBERG PHARMA NORTH AMERICA LLC
• UNII:
  • 7ZA48GIM5H
  • E3UT66504P
• RxNorm Concept Unique ID - RxCUI:
  • 1293268
  • 1250234
• UPC Code:
  • 0857074001774

NDC Crossover Matching brand name "Domeboro" or generic name "Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate"

NDC	Brand Name	Generic Name
16864-240	Domeboro	Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate
16864-250	DOMEBORO	Aluminum Acetate
0884-1706	Pedi-Boro Soak Paks	aluminum sulfate tetradecahydrate, calcium acetate monohydrate