NDC 16995-004

FLORIL TEARS

Polyvinyl Alcohol

FLORIL TEARS 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 Polyvinyl Alcohol.

Product ID16995-004_94f2f212-eba2-47a6-96ac-9f9639e2a09d
NDC16995-004
Product TypeHuman Otc Drug
Proprietary NameFLORIL TEARS
Generic NamePolyvinyl Alcohol
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 NamePOLYVINYL ALCOHOL
Active Ingredient Strength14 mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 16995-004-04

30 mL in 1 BOTTLE, DROPPER (16995-004-04)
Marketing Start Date2005-11-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16995-004-01 [16995000401]

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

NDC 16995-004-03 [16995000403]

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

NDC 16995-004-04 [16995000404]

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

NDC 16995-004-02 [16995000402]

FLORIL TEARS 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
POLYVINYL ALCOHOL14 mg/mL

OpenFDA Data

SPL SET ID:8101c006-0b47-4484-8760-a959764f555c
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 1039907
  • 1039905
  • NDC Crossover Matching brand name "FLORIL TEARS" or generic name "Polyvinyl Alcohol"

    NDCBrand NameGeneric Name
    16995-002FLORIL TEARSPOLYVINYL ALCOHOL
    16995-004FLORIL TEARSPOLYVINYL ALCOHOL
    0536-1970Artificial TearsPolyvinyl Alcohol
    13985-601Artificial TearsPolyvinyl Alcohol
    17478-060Artificial TearsPolyvinyl Alcohol
    37205-137Artificial TearsPolyvinyl Alcohol
    50090-0252Artificial TearsPolyvinyl Alcohol
    68788-9858Artificial TearsPolyvinyl Alcohol
    70403-920ARTIFICIAL TEARSPolyvinyl Alcohol
    11716-0001GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOL
    63187-298GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOL
    73921-001i-Drops ARTIFICIAL TEARSPolyvinyl Alcohol
    0904-5017LiquiTearsPolyvinyl Alcohol
    52959-041LiquiTearsPolyvinyl Alcohol
    0904-6492Major LiquiTearsPolyvinyl Alcohol
    50090-3158Major LiquiTearsPolyvinyl Alcohol
    71205-139Major LiquiTearsPolyvinyl Alcohol
    50268-678Polyvinyl AlcoholPolyvinyl Alcohol
    0536-1084Rugby Artificial TearsPolyvinyl Alcohol
    50090-2283Rugby Artificial TearsPolyvinyl Alcohol
    68071-4149Rugby Artificial TearsPolyvinyl Alcohol
    68788-6354Rugby Artificial TearsPolyvinyl Alcohol
    0536-1325Rugby Lubricating DropsPolyvinyl Alcohol
    50090-5996Rugby Lubricating DropsPolyvinyl Alcohol
    0536-1218Rugby Polyvinyl Alcohol Lubricating Eye Dropspolyvinyl alcohol

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