soteri skin baby 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 baby eczema relief cream
Generic Name colloidal oatmeal
Labeler soteri skin, inc
Dosage Form EMULSION
Routes
TOPICAL
Active Ingredients

oatmeal 2 g/100mL

Manufacturer
Soteri Skin, Inc

Identifiers & Regulatory

Product NDC 85265-104
Product ID 85265-104_45a1740f-c49f-d3a0-e063-6294a90ab46b
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 85265104
Hyphenated Format 85265-104

Supplemental Identifiers

RxCUI
1189915
UPC
0860008871336
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 baby eczema relief cream (source: ndc)
Generic Name colloidal oatmeal (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100mL
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (85265-104-01) / 100 mL in 1 BOTTLE, PUMP
source: ndc

Packages (1)

85265-104-01 1 BOTTLE, PUMP in 1 CARTON (85265-104-01) / 100 mL in 1 BOTTLE, PUMP

Ingredients (1)

oatmeal (2 g/100mL)

Linked Drug Pages (1)

Soteri Skin Baby Eczema Relief Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "45a1740f-c49f-d3a0-e063-6294a90ab46b", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "upc": ["0860008871336"], "unii": ["8PI54V663Y"], "rxcui": ["1189915"], "spl_set_id": ["41d88ff2-22aa-8447-e063-6294a90aea0e"], "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 (85265-104-01)  / 100 mL in 1 BOTTLE, PUMP", "package_ndc": "85265-104-01", "marketing_start_date": "20251023"}], "brand_name": "Soteri Skin Baby Eczema Relief Cream", "product_id": "85265-104_45a1740f-c49f-d3a0-e063-6294a90ab46b", "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": "85265-104", "generic_name": "Colloidal Oatmeal", "labeler_name": "Soteri Skin, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Soteri Skin Baby Eczema Relief Cream", "active_ingredients": [{"name": "OATMEAL", "strength": "2 g/100mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251023", "listing_expiration_date": "20261231"}