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 11 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily MoisturizingDIMETHICONEAldi, Inc118a1a07-7283-4353-97b5-6ac3b1cc14302026-05-08Warnings, Adverse reactionsExact identifier
application number: M016
DoveANTIBACTERIAL CARE MOISTURIZING CREAMConopco Inc. d/b/a/ Unilever5150f48c-ff0c-ce39-e063-6394a90ad4242026-05-08WarningsExact identifier
application number: M016
Seedlings Diaper Rash CreamZINC OXIDEYoung Living Essential Oils, LC.4d8aeaba-ddb1-6f74-e054-00144ff88e882026-05-08WarningsExact identifier
application number: M016
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.5120b708-047a-1182-e063-6394a90a74c32026-05-06WarningsExact identifier
application number: M016
AOAO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.512185a5-5c1d-ef9f-e063-6394a90a81af2026-05-06WarningsExact identifier
application number: M016
AKOLKOL TOENAIL FUNGUS TREATMENTGLYCERINShantou Ximonth Biotechnology Co., Ltd.5121c341-e5e9-2b36-e063-6394a90a93b82026-05-06WarningsExact identifier
application number: M016
Beyond Good Diaper RashZINC OXIDEBabylist, Inc512b62df-4f08-d839-e063-6294a90ab52f2026-05-06WarningsExact identifier
application number: M016
Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.4c531280-bc5b-1cf2-e063-6394a90a034a2026-05-05WarningsExact identifier
application number: M016
PEGO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.511eaced-c4d8-ae94-e063-6394a90a320e2026-05-05WarningsExact identifier
application number: M016
Rugby Gas reliefSIMETHICONERugby Laboratories9b84f74f-8609-489d-b411-3103afa1b5c22026-05-04WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMAldermed Inc.3f13a15c-8b64-48f0-a459-853b9097bc312026-05-04WarningsExact identifier
application number: M016
Zinc Oxide Skin ProtectantZINC OXIDE 20%Aldermed Inc.a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e522026-05-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMAldermed Inc.4e02af41-db86-46d8-a97d-332d84eced6f2026-05-04WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreensfc65f673-b23d-1ffa-e053-6394a90a09662026-05-03WarningsExact identifier
application number: M016
Dry Skin HealingPETROLATUMWalgreen0397507d-4b6e-c679-e063-6294a90a0b332026-05-03WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreenfc67037a-ed31-f678-e053-6394a90a71752026-05-03WarningsExact identifier
application number: M016
Skin ReliefLOTIONWalgreenfc678e80-e63d-e3fe-e053-6394a90aa7d62026-05-03WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWalmart INCf76ceecc-ef11-3839-e053-6394a90a8d4a2026-05-03WarningsExact identifier
application number: M016
Herpecin LDIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONEFocus Consumer Healthcare, LLC5b6ed4e9-3e69-c773-e053-2991aa0a7dfe2026-05-01WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact 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