NDC 63347-200

Antifungal

Undecylenic Acid

Antifungal is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Blaine Labs Inc.. The primary component is Undecylenic Acid.

Product ID63347-200_80736705-4909-41c6-8f0c-967b1fad94f9
NDC63347-200
Product TypeHuman Otc Drug
Proprietary NameAntifungal
Generic NameUndecylenic Acid
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2016-04-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333C
Labeler NameBlaine Labs Inc.
Substance NameUNDECYLENIC ACID
Active Ingredient Strength5 mg/36.97mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63347-200-01

36.97 mL in 1 BOTTLE (63347-200-01)
Marketing Start Date2016-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63347-200-01 [63347020001]

Antifungal CREAM
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-04-01

Drug Details

Active Ingredients

IngredientStrength
UNDECYLENIC ACID4.8 mg/36.97mL

OpenFDA Data

SPL SET ID:ee5fa679-5c30-4432-885f-9fb8129a8460
Manufacturer
UNII

NDC Crossover Matching brand name "Antifungal" or generic name "Undecylenic Acid"

NDCBrand NameGeneric Name
0472-0735AntifungalMiconazole Nitrate
11822-0154antifungaltolnaftate
11822-0351AntifungalClotrimazole
11822-0539antifungalTolnaftate
11822-3078AntifungalClotrimazole
41250-080AntifungalTerbinafine Hydrochloride
50090-1351AntifungalMiconazole Nitrate
50090-2231AntifungalMiconazole Nitrate
50090-2718AntifungalMiconazole Nitrate
50382-004AntifungalAntifungal
68345-817AntifungalAntifungal
68599-1470AntifungalAntifungal
68788-7374AntifungalAntifungal
55670-602AntifungalAntifungal
63187-885AntifungalAntifungal
63347-200AntifungalAntifungal
70000-0040AntifungalAntifungal
63868-685AntifungalAntifungal
0295-9008CVS Maximum Strength Anti-Fungal Pen 25%Undecylenic acid
52261-0202Fiore Rx Almond Milk Matte Antifungal Nail LacquerUndecylenic Acid
52261-0201Fiore Rx Antifungal Nail Lacquer Red Velvet CakeUndecylenic Acid
52261-0200Fiore Rx Pink Peppermint Pie Antifungal Nail PolishUndecylenic Acid
52261-0203Fiore Rx Rock Candy Clear Antifungal Nail LacquerUndecylenic Acid
43251-3351Flexitol Anti FungalUndecylenic acid
0295-9032Fungi Nail Toe and Foot Anti-FungalUndecylenic acid
0295-9810Fungicure Anti-Fungal Liquid 25%Undecylenic Acid
24385-676Good Neighbor Anti-FungalUndecylenic acid
0295-1032HC Max Hongo CuraUndecylenic acid
11673-488maximum strengthUNDECYLENIC ACID
50382-050MICONAZOLEantifungal
52083-242Myco Nail A Antifungal SolutionUndecylenic acid
43251-3361Natralia Anti FungalUndecylenic acid
11856-3365Pinceladas Goyescas OriginalUndecylenic Acid
11856-3367Pinceladas Goyescas OriginalUndecylenic Acid
11822-9650RIte AidUndecylenic Acid
11822-0250Rite Aid FungalUNDECYLENIC ACID
11096-190SANAFITILUndecylenic Acid
36800-754TopCare AntifungalUndecylenic Acid
11822-0028UNDECYLENIC ACIDUNDECYLENIC ACID
49035-987UNDECYLENIC ACIDUNDECYLENIC ACID
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