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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8PI54V663YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240651Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b65fc81-1b9e-4260-829a-332cf6891d02Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 12 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herpecin Pain ReliefALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCLFocus Consumer Healthcare, LLCbeeb6043-6547-4fe9-e053-2995a90a5d742026-04-30WarningsExact identifier
application number: M016
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
application number: M016
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALAmazon.com Services LLC423c821d-92af-47f0-b9ee-8b68ecbcc44e2026-04-29Warnings, Adverse reactionsExact identifier
application number: M016
MICRO INFUSIONSYSTEMSEEK GLONingbo Kenwei International Trade Co., Ltd.50746cab-bfcc-fe0b-e063-6394a90adc012026-04-27WarningsExact identifier
application number: M016
Pharmacy ChoiceMENTHOL, ZINC OXIDEPHARMACY CHOICE INC5031fc05-e1c7-40b1-e063-6394a90aa12c2026-04-24WarningsExact identifier
application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTIONSEL PH BABY PH-BALANCED ECZEMA DRYNESS BABYGuangzhou Ariel Biotech Co., Ltd.5040b707-87af-3859-e063-6294a90afb3d2026-04-24WarningsExact identifier
application number: M016
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
application number: M016
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
application number: M016
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
application number: M016
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONPharma Nobis, LLC4f853183-5925-2c73-e063-6394a90adf6c2026-04-15WarningsExact identifier
application number: M016
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENTDIMETHICONEBeverly Hills MD, LLC4ed33a43-d059-2589-e063-6294a90a30b32026-04-09WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
application number: M016
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact identifier
application number: M016

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