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 6 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mederma PM DIMETHICONE PMI Branded Pharmaceuticals, Inc. 26737285-f6ae-47eb-9019-33f1cfce3029 2026-07-15 Warnings Exact identifier application number: M016 MEDERMA STRETCH MARKS THERAPY DIMETHICONE L. Perrigo Company e9366775-e85b-4403-a2c5-12d9fb3cc3fa 2026-07-15 Warnings Exact identifier application number: M016 Remedy Barrier Cream Cloths Fragrance Free DIMETHICONE Medline Industries, LP 00e0cd4a-6049-408a-ab3f-9edf97e6438a 2026-07-14 Warnings Exact identifier application number: M016 Cruex Petroleum Jelly WHITE PETROLATUM MKJ BRANDS LLC 3e61191a-e0fa-3477-e063-6294a90a7d19 2026-07-14 Warnings Exact identifier application number: M016 Cruex Petroleum Jelly WHITE PETROLATUM MKJ BRANDS LLC 459a90b8-7d52-ef70-e063-6394a90ac1d0 2026-07-14 Warnings Exact identifier application number: M016 Mederma for Kids ALLANTOIN L. Perrigo Company ed4ff435-9819-46d3-9375-914712943f77 2026-07-14 Warnings Exact identifier application number: M016 Baby 3-in-1 Diaper Rash BABY 3-IN-1 DIAPER RASH Walgreens 5632dde2-f59d-3a45-e063-6394a90a1a24 2026-07-09 Warnings Exact identifier application number: M016 Drs. DIAPER RASH MAXIMUM STRENGTH ZINC OXIDE OL PHARMA TECH, LLC Drs PHARMACY 161ba174-1b13-83cd-e063-6394a90af19c 2026-07-09 Warnings Exact identifier application number: M016 Drs. Hydrocortisone Aloe Vera HYDROCORTISONE OL PHARMA TECH,LLC 0df06415-5d32-7ef8-e063-6294a90a6e5a 2026-07-09 Warnings Exact identifier application number: M016 SOHEJU Nail Repairs Patches GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 560089ff-3361-90b7-e063-6294a90ada42 2026-07-09 Warnings Exact identifier application number: M016 Bee Venom Psoriasis Wart Caring Cream GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 563a423c-e9dd-1cab-e063-6294a90a8c6a 2026-07-09 Warnings Exact identifier application number: M016 Skin Protectant with Lanolin LANOLIN McKesson Medical-Surgical Inc. 46df52c8-0cbf-213e-e054-00144ff88e88 2026-07-08 Warnings Exact identifier application number: M016 Skin Protectant with Lanolin LANOLIN McKesson 5abe1b34-f71b-2a90-e053-2991aa0aded6 2026-07-08 Warnings Exact identifier application number: M016 Walgreens Baby Healing Balm PETROLATUM Walgreens 561c1e1e-e896-d6e9-e063-6394a90ac0e7 2026-07-08 Warnings Exact identifier application number: M016 AD Overnight Healing AD OVERNIGHT HEALING WellSpring Pharmaceutical Corporation 57c29db6-da0c-4b28-86c0-6ac1b7122428 2026-07-07 Warnings Exact identifier application number: M016 EczeNourish Eczema and Psoriasis Soothing Oat COLLOIDAL OATMEAL Vanguard Soap, LLC 55f7137f-c5a5-f2ce-e063-6394a90a5280 2026-07-07 Warnings Exact identifier application number: M016 FDS intimate Whole Body Medicated Chafing FDS INTIMATE WHOLE BODY MEDICATED CHAFING WellSpring Pharmaceutical Corporation ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c 2026-07-07 Warnings Exact identifier application number: M016 AD First Aid Multipurpose AD FIRST AID MULTIPURPOSE WellSpring Pharmaceutical Corporation 999989d8-21c2-4380-b4c1-e5421189f6ed 2026-07-07 Warnings Exact identifier application number: M016 AD Anti-Chafing AD ANTI-CHAFING WellSpring Pharmaceutical Corporation d272ab4a-eb18-4f64-b925-fccf637dbb02 2026-07-06 Warnings Exact identifier application number: M016 ECZEMA NOURISH MEDICATED CLEANSING BAR COLLOIDAL OATMEAL SKIN PROTECTANT Vanguard Soap, LLC 55f865dc-d88e-fe2f-e063-6294a90aa7d3 2026-07-06 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