soteri skin active flare-up 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 active flare-up eczema relief cream
Generic Name colloidal oatmeal
Labeler soteri skin, inc.
Dosage Form EMULSION
Routes
TOPICAL
Active Ingredients

oatmeal 1.5 g/100mL

Manufacturer
Soteri Skin, Inc.

Identifiers & Regulatory

Product NDC 85265-102
Product ID 85265-102_45a1740f-c4a0-d3a0-e063-6294a90ab46b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2025-10-21

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 85265102
Hyphenated Format 85265-102

Supplemental Identifiers

RxCUI
1654721
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 active flare-up eczema relief cream (source: ndc)
Generic Name colloidal oatmeal (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.5 g/100mL
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (85265-102-01) / 100 mL in 1 BOTTLE, PUMP
source: ndc

Packages (1)

85265-102-01 1 BOTTLE, PUMP in 1 CARTON (85265-102-01) / 100 mL in 1 BOTTLE, PUMP

Ingredients (1)

oatmeal (1.5 g/100mL)

Linked Drug Pages (1)

Soteri Skin Active Flare-Up Eczema Relief Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "45a1740f-c4a0-d3a0-e063-6294a90ab46b", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "unii": ["8PI54V663Y"], "rxcui": ["1654721"], "spl_set_id": ["41b558d9-55ba-97ff-e063-6394a90a963b"], "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 (85265-102-01)  / 100 mL in 1 BOTTLE, PUMP", "package_ndc": "85265-102-01", "marketing_start_date": "20251021"}], "brand_name": "Soteri Skin Active Flare-Up Eczema Relief Cream", "product_id": "85265-102_45a1740f-c4a0-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": "85265-102", "generic_name": "Colloidal Oatmeal", "labeler_name": "Soteri Skin, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Soteri Skin Active Flare-Up Eczema Relief Cream", "active_ingredients": [{"name": "OATMEAL", "strength": "1.5 g/100mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251021", "listing_expiration_date": "20261231"}