Home NDC 61328-106 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 Ingredient Strength OATMEAL 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8PI54V663Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240651 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61328-106-11 SKINFIX HAND REPAIR 30 mL in 1 TUBE CREAM 30 11 61328-106-13 SKINFIX HAND REPAIR 90 mL in 1 TUBE CREAM 90 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OATMEAL ACTIVE INGREDIENT 8PI54V663Y SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 OATMEAL ACTIVE MOIETY 8PI54V663Y SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 CALENDULA OFFICINALIS WHOLE INACTIVE INGREDIENT PFR03EBU0H SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 CAPRYLYL CAPRYLATE/CAPRATE INACTIVE INGREDIENT 22MCG4RSMR SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 JOJOBA OIL INACTIVE INGREDIENT 724GKU717M SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 MATRICARIA CHAMOMILLA WHOLE INACTIVE INGREDIENT 2Z4LRR776S SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 OAT KERNEL OIL INACTIVE INGREDIENT 3UVP41R77R SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 ORYZA SATIVA WHOLE INACTIVE INGREDIENT 84IVV0906Z SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 POLYGLYCERYL-2 DIISOSTEARATE INACTIVE INGREDIENT DG195GP57P SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 ROSMARINUS OFFICINALIS WHOLE INACTIVE INGREDIENT EA3289138M SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 SHEA BUTTER INACTIVE INGREDIENT K49155WL9Y SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 TRISODIUM ETHYLENEDIAMINE DISUCCINATE INACTIVE INGREDIENT YA22H34H9Q SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61328-106 SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20241228_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 41 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join terrasil Infection Protection Wound Care ALLANTOIN Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions e98d1d8c-c979-49de-9bd8-cd409efff6de 2025-07-11 Warnings Exact identifier application number: M016 Neosporin Lip Health Overnight Renewal Therapy PETROLATUM Kenvue Brands LLC 0da54fe1-c99f-4a2d-9ee5-2dc24005096c 2025-07-10 Warnings Exact identifier application number: M016 COCOA BUTTER PETROLEUM jelly PETROLATUM Savvy Care & Cosmetics Pvt. Ltd. 397d13f1-3b86-3c76-e063-6394a90a0f24 2025-07-09 Warnings Exact identifier application number: M016 Pipette Eczema COLLOIDAL OATMEAL Pipette LLC 39829827-d801-f5a7-e063-6394a90a024c 2025-07-09 Warnings Exact identifier application number: M016 Zinc Oxide ZINC OXIDE Westminster Pharmaceuticals, LLC 7e045b3a-f33b-4faa-ab9b-2baec6ff7924 2025-07-08 Warnings Exact identifier application number: M016 Desitin Multi-Purpose Healing PETROLATUM Kenvue Brands LLC 30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab 2025-07-07 Warnings Exact identifier application number: M016 Astringent Solution ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE First Nation Group 065c895c-7d86-f1ed-e063-6394a90a3a52 2025-07-07 Warnings Exact identifier application number: M016 Creamy Petroleum PETROLATUM Savvy Care & Cosmetics Pvt Ltd 3916daee-f8d2-e3f0-e063-6294a90a3883 2025-07-04 Warnings Exact identifier application number: M016 Exemax Cream DIMETHICONE, ALLANTOIN PureTek Corporation 38e79055-df84-d314-e063-6394a90ac95f 2025-07-01 Warnings Exact identifier application number: M016 Procure Dimethicone 5% DIMETHICONE Twin Med LLC 38a7e4af-997d-549e-e063-6394a90a0bd6 2025-06-28 Warnings Exact identifier application number: M016 Zinc Oxide ZINC OXIDE OINTMENT Derma Sciences Canada Inc. 37eff762-1ea9-ec66-e063-6394a90a3d10 2025-06-19 Warnings Exact identifier application number: M016 Dr.Johnes SKIN TAG REMOVER SALICYLIC ACID Dr.Johnes LLC b731c55e-31ee-429f-8432-fac7c5718d83 2025-06-18 Warnings Exact identifier application number: M016 Dr. Johne SKIN TAG REMOVER SALICYLIC ACID Dr.Johnes LLC 6c5adc3c-9d45-449a-ad42-f9571851cd18 2025-06-18 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal OATMEAL THERAPLEX, LLC e51aa467-ffe7-4c6b-8588-6df8592596d4 2025-06-16 Warnings Exact identifier application number: M016 ZIIDII Wild Yam Cream WILD YAM Guangzhou Haishi Biological Technology Co., Ltd. 3733154a-4884-9988-e063-6294a90aa78c 2025-06-10 Warnings Exact identifier application number: M016 Aveeno Calm Plus Restore Skin Therapy Balm COLLOIDAL OATMEAL Kenvue Brands LLC dbe7a2cc-9c21-2a48-e053-2a95a90a54e2 2025-06-04 Warnings Exact identifier application number: M016 Petroleum Jelly WHITE PETROLATUM WALGREENS 2017113f-d192-5fbb-e063-6294a90a83b0 2025-05-31 Warnings Exact identifier application number: M016 AHHH Bite Relief SODIUM BICARBONATE 78271 25a1e070-9228-4ec9-e063-6294a90ad78d 2025-05-27 Warnings Exact identifier application number: M016 SupreH Bee Venom Skin Tag Treatment Liquid SUPREH BEE VENOM SKIN TAG REMOVER LIQUID Shenzhen Xinxin Yunhai Technology Co., Ltd. 35ca9836-917a-b0ac-e063-6294a90a28a2 2025-05-23 Warnings Exact identifier application number: M016 terrasil Diabetics Ulcer and Bed Sore Relief ALLANTOIN Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 35d2738c-dacf-7309-e063-6294a90aab4c 2025-05-23 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61328-106-10 61328010610 10 mL in 1 TUBE (61328-106-10) 10 ml 2017-03-15 0000-00-00 No No Current 61328-106-11 61328010611 30 mL in 1 TUBE (61328-106-11) 30 ml 2016-09-23 0000-00-00 No No Current 61328-106-12 61328010612 60 mL in 1 TUBE (61328-106-12) 60 ml 2016-09-23 0000-00-00 No No Current 61328-106-13 61328010613 90 mL in 1 TUBE (61328-106-13) 90 ml 2014-07-02 0000-00-00 No No Current 61328-106-15 61328010615 150 mL in 1 TUBE (61328-106-15) 150 ml 2018-10-01 0000-00-00 No No Current 61328-106-16 61328010616 148 mL in 1 PACKAGE (61328-106-16) 148 ml 2018-12-26 0000-00-00 No No Current 61328-106-97 61328010697 7 mL in 1 POUCH (61328-106-97) 7 ml 2016-09-23 0000-00-00 No No Current