NDC 58354-100

Galeo

Dihydroxydibutylether

Galeo is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Cho-a Pharm.co.,ltd.. The primary component is 4,4'-oxydi-2-butanol.

• Product ID: 58354-100_76daffb5-71ec-463f-aae0-c7920acef51d
• NDC: 58354-100
• Product Type: Human Otc Drug
• Proprietary Name: Galeo
• Generic Name: Dihydroxydibutylether
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-28
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Cho-A Pharm.Co.,Ltd.
• Substance Name: 4,4'-OXYDI-2-BUTANOL
• Active Ingredient Strength: 5 g/50mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 58354-100-02

1 BOTTLE in 1 PACKAGE (58354-100-02) > 50 mL in 1 BOTTLE (58354-100-01)

• Marketing Start Date: 2017-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58354-100-01 [58354010001]

Galeo LIQUID

• Marketing Category: unapproved drug other
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-02-28

NDC 58354-100-02 [58354010002]

Galeo LIQUID

• Marketing Category: unapproved drug other
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-02-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
4,4'-OXYDI-2-BUTANOL	5 g/50mL

OpenFDA Data

• SPL SET ID: be9d1f8c-f7b8-41fc-8c3f-d471dd6534c8
• Manufacturer:
  • Cho-A Pharm.Co.,Ltd.
• UNII:
  • CR6X2Y7NRR