FDA.reportPublic FDA data

SKINFIX HAND REPAIR

Product NDC
61328-106
11-digit product format
613280106
Labeler code
61328
Product ID
61328-106_48338cc0-20ec-8999-e063-6394a90aba83
Type
HUMAN OTC DRUG
Nonproprietary name
OATMEAL
Dosage form
CREAM
Route
TOPICAL
Labeler
Skinfix, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-02
Substance
OATMEAL
Active strength
1 g/100mL
Pharmacologic classes
Allergens [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 flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SKINFIX HAND REPAIR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui240651

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61328-106-11SKINFIX HAND REPAIR30 mL in 1 TUBECREAM3011
61328-106-13SKINFIX HAND REPAIR90 mL in 1 TUBECREAM9011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663YSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
OATMEALACTIVE MOIETY8PI54V663YSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0ZSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
CALENDULA OFFICINALIS WHOLEINACTIVE INGREDIENTPFR03EBU0HSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
CAPRYLYL CAPRYLATE/CAPRATEINACTIVE INGREDIENT22MCG4RSMRSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
MATRICARIA CHAMOMILLA WHOLEINACTIVE INGREDIENT2Z4LRR776SSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
OAT KERNEL OILINACTIVE INGREDIENT3UVP41R77RSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
ORYZA SATIVA WHOLEINACTIVE INGREDIENT84IVV0906ZSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
POLYGLYCERYL-2 DIISOSTEARATEINACTIVE INGREDIENTDG195GP57PSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
ROSMARINUS OFFICINALIS WHOLEINACTIVE INGREDIENTEA3289138MSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YISKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
TRISODIUM ETHYLENEDIAMINE DISUCCINATEINACTIVE INGREDIENTYA22H34H9QSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VSKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61328-106SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]9Current NDC, Legacy NDC, 2 package rows20241228_1b65fc81-1b9e-4260-829a-332cf6891d02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN1b65fc81-1b9e-4260-829a-332cf6891d0211
240651colloidal oatmeal 10 MG/ML Topical CreamSCD1b65fc81-1b9e-4260-829a-332cf6891d0211
240651Avena sativa 1 % Topical CreamSY1b65fc81-1b9e-4260-829a-332cf6891d0211
240651colloidal oatmeal 1 % Topical CreamSY1b65fc81-1b9e-4260-829a-332cf6891d0211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61328-106-106132801061010 mL in 1 TUBE (61328-106-10) 10 ml2017-03-150000-00-00NoNoCurrent
61328-106-116132801061130 mL in 1 TUBE (61328-106-11) 30 ml2016-09-230000-00-00NoNoCurrent
61328-106-126132801061260 mL in 1 TUBE (61328-106-12) 60 ml2016-09-230000-00-00NoNoCurrent
61328-106-136132801061390 mL in 1 TUBE (61328-106-13) 90 ml2014-07-020000-00-00NoNoCurrent
61328-106-1561328010615150 mL in 1 TUBE (61328-106-15) 150 ml2018-10-010000-00-00NoNoCurrent
61328-106-1661328010616148 mL in 1 PACKAGE (61328-106-16) 148 ml2018-12-260000-00-00NoNoCurrent
61328-106-97613280106977 mL in 1 POUCH (61328-106-97) 7 ml2016-09-230000-00-00NoNoCurrent