atopis eczema therapy cream

Generic: colloidal oatmeal

Labeler: bionona limited
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name atopis eczema therapy cream
Generic Name colloidal oatmeal
Labeler bionona limited
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

oatmeal .5 g/100g

Manufacturer
Bionona Limited

Identifiers & Regulatory

Product NDC 71570-001
Product ID 71570-001_2919c17e-5f02-d32a-e063-6294a90abacb
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2019-07-15

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 71570001
Hyphenated Format 71570-001

Supplemental Identifiers

RxCUI
1654149
UPC
0735850153957
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 atopis eczema therapy cream (source: ndc)
Generic Name colloidal oatmeal (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 g/100g
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (71570-001-01) / 75 g in 1 BOTTLE
source: ndc

Packages (1)

71570-001-01 1 BOTTLE in 1 CARTON (71570-001-01) / 75 g in 1 BOTTLE

Ingredients (1)

oatmeal (.5 g/100g)

Linked Drug Pages (1)

Atopis Eczema Therapy Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2919c17e-5f02-d32a-e063-6294a90abacb", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "upc": ["0735850153957"], "unii": ["8PI54V663Y"], "rxcui": ["1654149"], "spl_set_id": ["8d4b4a14-b631-f2fa-e053-2a95a90a932f"], "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": ["Bionona Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71570-001-01)  / 75 g in 1 BOTTLE", "package_ndc": "71570-001-01", "marketing_start_date": "20190715"}], "brand_name": "Atopis Eczema Therapy Cream", "product_id": "71570-001_2919c17e-5f02-d32a-e063-6294a90abacb", "dosage_form": "CREAM", "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": "71570-001", "generic_name": "Colloidal Oatmeal", "labeler_name": "Bionona Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Atopis Eczema Therapy Cream", "active_ingredients": [{"name": "OATMEAL", "strength": ".5 g/100g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190715", "listing_expiration_date": "20261231"}