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 ID16995-001_e4ff216e-e4a8-4c7e-b752-ce1621eba1b5
NDC16995-001
Product TypeHuman Otc Drug
Proprietary NameFLORIL REDNESS RELIEF
Generic NameNaphazoline Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2005-11-10
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameVITALINE S.A.C.
Substance NameNAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 20
Active Ingredient Strength3 mg/10mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 16995-001-01

3 mL in 1 BOTTLE, DROPPER (16995-001-01)
Marketing Start Date2005-11-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16995-001-04 [16995000104]

FLORIL REDNESS RELIEF SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-11-10
Inactivation Date2019-10-21

NDC 16995-001-02 [16995000102]

FLORIL REDNESS RELIEF SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-11-10
Inactivation Date2019-10-21

NDC 16995-001-01 [16995000101]

FLORIL REDNESS RELIEF SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-11-10
Inactivation Date2019-10-21

NDC 16995-001-03 [16995000103]

FLORIL REDNESS RELIEF SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-11-10
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
NAPHAZOLINE HYDROCHLORIDE3 mg/10mL

OpenFDA Data

SPL SET ID:be1d52aa-2a40-42d6-8108-ab02bb37711b
Manufacturer
UNII

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

NDCBrand NameGeneric Name
16995-001FLORIL REDNESS RELIEFNAPHAZOLINE HYDROCHLORIDE
21695-915AK-Connaphazoline hydrochloride
48462-001NAFASOLINANAPHAZOLINE HYDROCHLORIDE
63187-412NaphazolineNaphazoline Hydrochloride
49873-057NazalNaphazoline hydrochloride
51367-008Pi Yen ChinNaphazoline Hydrochloride
51367-035Pi Yen ChinNaphazoline Hydrochloride
63736-662PrivineNaphazoline Hydrochloride
63736-663PrivineNaphazoline Hydrochloride
49873-044Sato ClearNAPHAZOLINE HYDROCHLORIDE

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