NDC 61328-001

Diaper Rash Balm

Skin Protectant

Diaper Rash Balm is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Skinfix, Inc.. The primary component is Zinc Oxide.

Product ID61328-001_535621dd-c4e6-47c0-8f02-0c4698acb61a
NDC61328-001
Product TypeHuman Otc Drug
Proprietary NameDiaper Rash Balm
Generic NameSkin Protectant
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2013-12-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameSkinfix, Inc.
Substance NameZINC OXIDE
Active Ingredient Strength0 g/g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61328-001-02

114 g in 1 JAR (61328-001-02)
Marketing Start Date2013-12-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61328-001-02 [61328000102]

Diaper Rash Balm OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-12-17
Inactivation Date2019-11-27

NDC 61328-001-01 [61328000101]

Diaper Rash Balm OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-12-09
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE.2 g/g

OpenFDA Data

SPL SET ID:e5952327-ac46-43a9-b835-afbf1fe84032
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198911
  • NDC Crossover Matching brand name "Diaper Rash Balm" or generic name "Skin Protectant"

    NDCBrand NameGeneric Name
    61328-001Diaper Rash BalmSkin Protectant
    50017-023Action Creamskin protectant
    50017-026BabyB BabySaverskin protectant
    50017-027BabyB BabySaverskin protectant
    50017-022Bodysaverskin protectant
    61924-174DermaCerinSkin Protectant
    61924-214DermaMedSkin Protectant
    61924-184DermaphorSkin Protectant
    68599-0218DimethiconeSkin Protectant
    65112-250EczaCalmSkin Protectant
    61328-007Healing Foot and Leg BalmSkin Protectant
    61328-005Kids Eczema BalmSkin Protectant
    61924-410Renew Dimethicone Skin ProtectantSkin Protectant
    61924-435Renew PeriprotectSkin Protectant
    59305-028Senior BSkin Protectant
    62932-227Skin ProtectantSkin Protectant
    62932-228Skin ProtectantSkin Protectant
    53329-090Vitamin A and DSkin Protectant
    67777-006Vitamins A and D Without LanolinSkin Protectant
    68001-532Zinc OxideSkin Protectant
    68001-533Zinc OxideSkin Protectant

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