NDC 49873-501

Optic Splash

Naphazoline Hydrochloride, Glycerin

Optic Splash is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Sato Pharmaceutical, Co., Ltd.. The primary component is Naphazoline Hydrochloride; Glycerin.

• Product ID: 49873-501_3639b8df-0b0f-4f36-bd3c-73f222b71b53
• NDC: 49873-501
• Product Type: Human Otc Drug
• Proprietary Name: Optic Splash
• Generic Name: Naphazoline Hydrochloride, Glycerin
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2008-01-22
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: Sato Pharmaceutical, Co., Ltd.
• Substance Name: NAPHAZOLINE HYDROCHLORIDE; GLYCERIN
• Active Ingredient Strength: 20 mg/100mL; mg/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 49873-501-01

1 BOTTLE in 1 CARTON (49873-501-01) > 15 mL in 1 BOTTLE

• Marketing Start Date: 2008-01-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49873-501-01 [49873050101]

Optic Splash SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2008-01-22

Drug Details

Active Ingredients

Ingredient	Strength
NAPHAZOLINE HYDROCHLORIDE	20 mg/100mL

OpenFDA Data

• SPL SET ID: e3d60c20-7cbc-4728-8e42-441b64608b88
• Manufacturer:
  • Sato Pharmaceutical, Co., Ltd.
• UNII:
  • MZ1131787D
  • PDC6A3C0OX
• RxNorm Concept Unique ID - RxCUI:
  • 1243999
• UPC Code:
  • 0349873502014

NDC Crossover Matching brand name "Optic Splash" or generic name "Naphazoline Hydrochloride, Glycerin"

NDC	Brand Name	Generic Name
49873-501	Optic Splash	naphazoline hydrochloride, glycerin
55651-050	Eye Drops Redness and Dry Eye Relief	Naphazoline hydrochloride, Glycerin
62011-0100	Eye Drops Redness and Dry Eye Relief	Naphazoline hydrochloride, Glycerin