soteri skin long-term eczema relief cream

Generic: colloidal oatmeal

Labeler: soteri skin, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name soteri skin long-term eczema relief cream
Generic Name colloidal oatmeal
Labeler soteri skin, inc
Dosage Form EMULSION
Routes
TOPICAL
Active Ingredients

oatmeal 1 g/100mL

Manufacturer
Soteri Skin, Inc

Identifiers & Regulatory

Product NDC 85265-103
Product ID 85265-103_4590423c-a785-dae2-e063-6394a90a0438
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2025-10-23

Pharmacologic Class

Established (EPC)
non-standardized food allergenic extract [epc] non-standardized plant allergenic extract [epc]
Chemical Structure
allergens [cs] dietary proteins [cs] plant proteins [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85265103
Hyphenated Format 85265-103

Supplemental Identifiers

RxCUI
240651
UPC
0860008871329
UNII
8PI54V663Y
NUI
N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 N0000185016

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name soteri skin long-term eczema relief cream (source: ndc)
Generic Name colloidal oatmeal (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100mL
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (85265-103-01) / 100 mL in 1 BOTTLE, PUMP
source: ndc

Packages (1)

85265-103-01 1 BOTTLE, PUMP in 1 CARTON (85265-103-01) / 100 mL in 1 BOTTLE, PUMP

Ingredients (1)

oatmeal (1 g/100mL)

Linked Drug Pages (1)

Soteri Skin Long-Term Eczema Relief Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4590423c-a785-dae2-e063-6394a90a0438", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "upc": ["0860008871329"], "unii": ["8PI54V663Y"], "rxcui": ["240651"], "spl_set_id": ["41d752cb-3866-e840-e063-6394a90acc37"], "pharm_class_cs": ["Allergens [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]"], "manufacturer_name": ["Soteri Skin, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (85265-103-01)  / 100 mL in 1 BOTTLE, PUMP", "package_ndc": "85265-103-01", "marketing_start_date": "20251023"}], "brand_name": "Soteri Skin Long-Term Eczema Relief Cream", "product_id": "85265-103_4590423c-a785-dae2-e063-6394a90a0438", "dosage_form": "EMULSION", "pharm_class": ["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]"], "product_ndc": "85265-103", "generic_name": "Colloidal Oatmeal", "labeler_name": "Soteri Skin, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Soteri Skin Long-Term Eczema Relief Cream", "active_ingredients": [{"name": "OATMEAL", "strength": "1 g/100mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251023", "listing_expiration_date": "20261231"}