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 51 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Copperlife Foot DIMETHICONE 1% Tommie Copper, Inc. cb825d2c-6333-3c1f-e053-2995a90a78f3 2024-12-15 Warnings Exact identifier application number: M016 Tommie Copper Foot DIMETHICONE 1% Tommie Copper, Inc. ca3d3374-a3d4-69e5-e053-2995a90a3ece 2024-12-15 Warnings Exact identifier application number: M016 Evereden Healing Eczema Treatment COLLOIDAL OATMEAL Eden Brands, Inc. d43f0eaa-aab0-eaff-e053-2995a90ac5c8 2024-12-13 Warnings Exact identifier application number: M016 Babo Fragrance Free Diaper Cream ZINC OXIDE Babo Botanicals, Inc. adcd4fc7-c400-fc8e-e053-2a95a90a7e1f 2024-12-12 Warnings Exact identifier application number: M016 Domeboro ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE Advantice Health, LLC. 28c39200-2f7c-954b-3ce7-7349b2738812 2024-12-12 Warnings Exact identifier application number: M016 Atopis Eczema Therapy Cream COLLOIDAL OATMEAL Bionona Limited 8d4b4a14-b631-f2fa-e053-2a95a90a932f 2024-12-12 Warnings Exact identifier application number: M016 Desitin Daily Defense Zinc Oxide Diaper Rash ZINC OXIDE Kenvue Brands LLC b6e0d1a3-e469-4102-916b-d5cc8ca12e73 2024-12-11 Warnings Exact identifier application number: M016 Little Me Multipurpose Baby Balm WHITE PETROLATUM Shalom International Corp e09518f1-3691-4d85-a8e1-a5c452057066 2024-12-11 Warnings Exact identifier application number: M016 Blistex Ivarest Poison Ivy Itch ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE Blistex Inc. e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a 2024-12-11 Warnings Exact identifier application number: M016 Deep Renewal Broad Spectrum DIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATE Blistex Inc 11c0e084-dc40-4969-a176-3af4116d6f27 2024-12-10 Warnings Exact identifier application number: M016 BOA VIDA Recovery Creme DIMETHICONE Central Solutions Inc bfa07058-7a20-4b9f-bad1-4b9fb5c037e0 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Canopy DIMETHICONE Central Solutions Inc 44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf 2024-12-09 Warnings Exact identifier application number: M016 DermaCen Skin Protectant ZINC OXIDE Central Solutions Inc 990c3a65-bca5-1f0d-e053-2995a90aa7ae 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Calvida ZINC OXIDE Central Solutions Inc 48eb2031-bc80-45d5-b8b3-cc08fcab64f1 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Cleansing DIMETHICONE Central Solutions Inc 0b456b20-ab06-4adf-b5f0-1693d33979df 2024-12-09 Warnings Exact identifier application number: M016 SOOTHE Sensitive Skin Treatment ALLANTOIN, DIMETHICONE Rodan & Fields 2bd8cac4-5f40-4d04-91f2-3ea8a138033b 2024-12-09 Warnings Exact identifier application number: M016 Aveeno Eczema Therapy Rescue Relief Treatment COLLOIDAL OATMEAL Kenvue Brands LLC f67e528a-b822-3f7a-e053-2995a90ae733 2024-12-06 Warnings Exact identifier application number: M016 Humphreys Maravilla WITCH HAZEL Humphreys Pharmacal, Incorporated 7d403bf4-8a0d-4337-8e81-1149cd0ae1dc 2024-12-06 Warnings Exact identifier application number: M016 Skin Soothing Cream COLLOIDAL OATMEAL Allure Labs Inc 9b1dfb4b-ce35-46a1-bfc6-ee5b871955f3 2024-12-05 Warnings Exact identifier application number: M016 Skin Soothing Cream - Nut Free COLLOIDAL OATMEAL Allure Labs b5eb48a5-e884-3bf6-e053-2a95a90abb97 2024-12-05 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