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 8 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA8cbe9b1f-fec0-9579-e053-2995a90ac4612026-06-22WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMWalmart Inc.e294a871-ae73-4a4f-89a3-9ebf0b4fd03a2026-06-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper Rash CreamZINC OXIDEFoshan Desha Biotechnology Co., Ltd.5487ad62-3d73-042e-e063-6394a90afe8c2026-06-18WarningsExact identifier
application number: M016
Baby HealingOintmentPETROLATUMFoshan Desha Biotechnology Co., Ltd.5488b81a-e5fe-1452-e063-6394a90a2ae42026-06-18WarningsExact identifier
application number: M016
Baby Eczema Moisturizing CreamCOLLOIDAL OATMEALFoshan Desha Biotechnology Co., Ltd.548a0c34-6aac-14f7-e063-6394a90ae6522026-06-18WarningsExact identifier
application number: M016
Jell with Vitamin A DLANOLIN, PETROLATUMJell Pharmaceuticals Pvt Ltd.d976e5f0-1be5-d9c4-e053-2a95a90a44a42026-06-17WarningsExact identifier
application number: M016
DoveANTIBACTERIAL CARE BEAUTY BARConopco d/b/a Unilever547472cf-4902-584e-e063-6294a90a28ac2026-06-17WarningsExact identifier
application number: M016
Dr Sosnowskis Chafing Hero Severe Chafing BalmLANOLINHerstat (USA) Inc.389041a8-7316-b38e-e063-6294a90a3e8e2026-06-17WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Cocoa Butter Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY546749e3-70c5-10e8-e063-6294a90ad8c42026-06-16WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY54698388-f9e8-c470-e063-6394a90a783b2026-06-16WarningsExact identifier
application number: M016
MedlineZINC OXIDEMedline Industries, LP3c319953-04fc-87a8-e063-6294a90a50582026-06-15WarningsExact identifier
application number: M016
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
HEALMUSZ HEALTHY FEETUREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEETJiangxi Yudexi Pharmaceutical Co., LTD4a34b6de-03ec-3be4-e063-6294a90afb522026-06-14WarningsExact identifier
application number: M016
PUVIDA SNOW BLEACHNIACINAMIDE 15% SNOW BLEACHJiangxi Yudexi Pharmaceutical Co., LTD4a48ebbd-7c80-1bce-e063-6294a90ab4ae2026-06-14WarningsExact identifier
application number: M016
XIMONTH Foot Shoe DeodorizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.541d9ce9-62ad-847e-e063-6394a90a55e02026-06-13WarningsExact identifier
application number: M016
Skin Protectant with 33% Petrolatum Advance Moisturizing CreamPETROLATUMAldermed Inc.87413149-d39f-4f8a-b1c9-6de5eb37ff7e2026-06-12WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDE, WHITE PETROLATUMAldermed Inc.54154a72-27ad-7bfa-e063-6394a90a4eca2026-06-12WarningsExact identifier
application number: M016
Circletong Tag Wart Remover PatchesGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.541b0fe9-f900-8191-e063-6394a90af3212026-06-12WarningsExact identifier
application number: M016
Baby ButzZINC OXIDEOlen Skin Care Corporatione6be6b62-13a4-410d-b8ac-457b58fd23da2026-06-10WarningsExact 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