NDC 16995-001

FLORIL REDNESS RELIEF

Naphazoline Hydrochloride

FLORIL REDNESS RELIEF is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Vitaline S.a.c.. The primary component is Naphazoline Hydrochloride; Polysorbate 20.

• Product ID: 16995-001_e4ff216e-e4a8-4c7e-b752-ce1621eba1b5
• NDC: 16995-001
• Product Type: Human Otc Drug
• Proprietary Name: FLORIL REDNESS RELIEF
• Generic Name: Naphazoline Hydrochloride
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2005-11-10
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: VITALINE S.A.C.
• Substance Name: NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 20
• Active Ingredient Strength: 3 mg/10mL; mg/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 16995-001-01

3 mL in 1 BOTTLE, DROPPER (16995-001-01)

• Marketing Start Date: 2005-11-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16995-001-04 [16995000104]

FLORIL REDNESS RELIEF SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2005-11-10
• Inactivation Date: 2019-10-21

NDC 16995-001-02 [16995000102]

FLORIL REDNESS RELIEF SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2005-11-10
• Inactivation Date: 2019-10-21

NDC 16995-001-01 [16995000101]

FLORIL REDNESS RELIEF SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2005-11-10
• Inactivation Date: 2019-10-21

NDC 16995-001-03 [16995000103]

FLORIL REDNESS RELIEF SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2005-11-10
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
NAPHAZOLINE HYDROCHLORIDE	3 mg/10mL

OpenFDA Data

• SPL SET ID: be1d52aa-2a40-42d6-8108-ab02bb37711b
• Manufacturer:
  • VITALINE S.A.C.
• UNII:
  • MZ1131787D
  • 7T1F30V5YH

NDC Crossover Matching brand name "FLORIL REDNESS RELIEF" or generic name "Naphazoline Hydrochloride"

NDC	Brand Name	Generic Name
16995-001	FLORIL REDNESS RELIEF	NAPHAZOLINE HYDROCHLORIDE
21695-915	AK-Con	naphazoline hydrochloride
48462-001	NAFASOLINA	NAPHAZOLINE HYDROCHLORIDE
63187-412	Naphazoline	Naphazoline Hydrochloride
49873-057	Nazal	Naphazoline hydrochloride
51367-008	Pi Yen Chin	Naphazoline Hydrochloride
51367-035	Pi Yen Chin	Naphazoline Hydrochloride
63736-662	Privine	Naphazoline Hydrochloride
63736-663	Privine	Naphazoline Hydrochloride
49873-044	Sato Clear	NAPHAZOLINE HYDROCHLORIDE