NDC 61328-121

DERMATITIS FACE BALM

Colloidal Oatmeal

DERMATITIS FACE BALM is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Skinfix, Inc.. The primary component is Oatmeal.

Product ID61328-121_060105d3-505b-4b16-8f2e-747523bbf7f6
NDC61328-121
Product TypeHuman Otc Drug
Proprietary NameDERMATITIS FACE BALM
Generic NameColloidal Oatmeal
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2022-02-03
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameSkinfix, Inc.
Substance NameOATMEAL
Active Ingredient Strength5 g/100g
Pharm ClassesAllergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 61328-121-12

13.5 g in 1 TUBE (61328-121-12)
Marketing Start Date2022-02-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61328-121-12 [61328012112]

DERMATITIS FACE BALM OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-26

NDC 61328-121-11 [61328012111]

DERMATITIS FACE BALM OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-26
Marketing End Date2020-01-03

Drug Details

Active Ingredients

IngredientStrength
OATMEAL5 g/100g

OpenFDA Data

SPL SET ID:86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738987

    • NDC Crossover Matching brand name "DERMATITIS FACE BALM" or generic name "Colloidal Oatmeal"

    NDCBrand NameGeneric Name
    61328-121DERMATITIS FACE BALMDERMATITIS FACE BALM
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    10738-054TRIDERMA ECZEMA FAST HEALING FACE AND BODYCOLLOIDAL OATMEAL
    0363-3550Walgreens Baby EczemaColloidal Oatmeal
    0363-0993WALGREENS ECZEMACOLLOIDAL OATMEAL
    0363-4429Well Beginnings Baby EczemaColloidal Oatmeal
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