NDC 55651-012

Eye Drops Extra

Tetrahydrozoline Hydrochloride, Polyethylene Glycol 400

Eye Drops Extra is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Kc Pharmaceuticals, Inc.. The primary component is Tetrahydrozoline Hydrochloride; Polyethylene Glycol 400.

• Product ID: 55651-012_05d1bdb4-1d77-47ef-95e9-e418c9ee2a9b
• NDC: 55651-012
• Product Type: Human Otc Drug
• Proprietary Name: Eye Drops Extra
• Generic Name: Tetrahydrozoline Hydrochloride, Polyethylene Glycol 400
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2003-12-09
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: KC Pharmaceuticals, Inc.
• Substance Name: TETRAHYDROZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 400
• Active Ingredient Strength: 1 mg/mL; mg/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 55651-012-01

1 BOTTLE, DROPPER in 1 CARTON (55651-012-01) > 15 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2003-12-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55651-012-01 [55651001201]

Eye Drops Extra SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2003-12-09
• Marketing End Date: 2003-12-09

Drug Details

Active Ingredients

Ingredient	Strength
TETRAHYDROZOLINE HYDROCHLORIDE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 8c12bbb9-7b04-4bd5-9147-fc83f174bec5
• Manufacturer:
  • KC Pharmaceuticals, Inc.
• UNII:
  • B697894SGQ
  • 0YZT43HS7D
• RxNorm Concept Unique ID - RxCUI:
  • 996209