NDC 0168-0126

Swim-EAR

Swim-ear

Swim-EAR is a Auricular (otic) Solution in the Human Otc Drug category. It is labeled and distributed by Fougera Pharmaceuticals Inc.. The primary component is Isopropyl Alcohol.

• Product ID: 0168-0126_4592e208-4cec-4edb-a704-b1830126451b
• NDC: 0168-0126
• Product Type: Human Otc Drug
• Proprietary Name: Swim-EAR
• Generic Name: Swim-ear
• Dosage Form: Solution
• Route of Administration: AURICULAR (OTIC)
• Marketing Start Date: 1970-04-03
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part344
• Labeler Name: Fougera Pharmaceuticals Inc.
• Substance Name: ISOPROPYL ALCOHOL
• Active Ingredient Strength: 950 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0168-0126-91

1 BOTTLE, DROPPER in 1 CARTON (0168-0126-91) > 29.57 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 1970-04-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0168-0126-91 [00168012691]

Swim-EAR SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part344
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 1970-04-03

Drug Details

Active Ingredients

Ingredient	Strength
ISOPROPYL ALCOHOL	950 mg/mL

OpenFDA Data

• SPL SET ID: b849acb5-e20b-464c-948b-8dcc51fdaf70
• Manufacturer:
  • E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• UNII:
  • ND2M416302
• RxNorm Concept Unique ID - RxCUI:
  • 631799