Derma Breeze Skin Protectant Cream

Product NDC
69475-5411
11-digit product format
694755411
Labeler code
69475
Product ID
69475-5411_24fc11d4-5d8c-2f53-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Greyson International, Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-09-15
Marketing end
0000-00-00
Substance
OATMEAL
Active strength
10 mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69475-5411-02020-01-31C16284748780-19d75b9d1-0378-f424-e053-dadaa90a57ceDerma Breeze 1% colloidal oatmeal with Trilexon
69475-5411-12020-01-31C16284748780-19d75b9d1-0378-f424-e053-dadaa90a57ceDerma Breeze 1% colloidal oatmeal with Trilexon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69475-5411-0Derma Breeze Skin Protectant Cream28.35 g in 1 TUBECREAM28.353
69475-5411-1Derma Breeze Skin Protectant Cream1000 g in 1 CONTAINERCREAM10003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663YDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
OATMEALACTIVE MOIETY8PI54V663YDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
CURDLANINACTIVE INGREDIENT6930DL209RDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3XDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
ISOCETYL STEARATEINACTIVE INGREDIENT3RJ7186O9WDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
PEG-10 SOY STEROLINACTIVE INGREDIENTFG54K98L0QDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
PPG-51/SMDI COPOLYMERINACTIVE INGREDIENTKQ9JG3O3YADERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
PROPYLENE GLYCOL STEARATEINACTIVE INGREDIENTMZM1I680W0DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
SACCHARIDE ISOMERATEINACTIVE INGREDIENTW8K377W98IDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RDERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69475-5411DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]3Legacy NDC, 2 package rows20151120_24736c38-1b5c-6514-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN24736c38-1b5c-6514-e054-00144ff8d46c3
240651colloidal oatmeal 10 MG/ML Topical CreamSCD24736c38-1b5c-6514-e054-00144ff8d46c3
240651Avena sativa 1 % Topical CreamSY24736c38-1b5c-6514-e054-00144ff8d46c3
240651colloidal oatmeal 1 % Topical CreamSY24736c38-1b5c-6514-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69475-5411-06947554110028.35 g in 1 TUBE28.35 gHistorical
69475-5411-1694755411011000 g in 1 CONTAINER1000 gHistorical