renew intensive skin therapy targeted eczema treatment

Generic: colloidal oatmeal

Labeler: melaleuca inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name renew intensive skin therapy targeted eczema treatment
Generic Name colloidal oatmeal
Labeler melaleuca inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

oatmeal .5 g/50mL

Manufacturer
Melaleuca Inc.

Identifiers & Regulatory

Product NDC 54473-410
Product ID 54473-410_42790fbf-5c8b-ad6b-e063-6294a90af297
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

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 54473410
Hyphenated Format 54473-410

Supplemental Identifiers

RxCUI
240651
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 renew intensive skin therapy targeted eczema treatment (source: ndc)
Generic Name colloidal oatmeal (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 g/50mL
source: ndc
Packaging
  • 50 mL in 1 TUBE, WITH APPLICATOR (54473-410-01)
source: ndc

Packages (1)

54473-410-01 50 mL in 1 TUBE, WITH APPLICATOR (54473-410-01)

Ingredients (1)

oatmeal (.5 g/50mL)

Linked Drug Pages (1)

Renew Intensive Skin Therapy Targeted Eczema Treatment ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "42790fbf-5c8b-ad6b-e063-6294a90af297", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "unii": ["8PI54V663Y"], "rxcui": ["240651"], "spl_set_id": ["198c7caf-576b-1466-e063-6394a90afe25"], "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": ["Melaleuca Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 TUBE, WITH APPLICATOR (54473-410-01)", "package_ndc": "54473-410-01", "marketing_start_date": "20240101"}], "brand_name": "Renew Intensive Skin Therapy Targeted Eczema Treatment", "product_id": "54473-410_42790fbf-5c8b-ad6b-e063-6294a90af297", "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": "54473-410", "generic_name": "Colloidal Oatmeal", "labeler_name": "Melaleuca Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Renew Intensive Skin Therapy", "brand_name_suffix": "Targeted Eczema Treatment", "active_ingredients": [{"name": "OATMEAL", "strength": ".5 g/50mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}