theraplex eczema therapy moisturizing skin protectant with colloidal oatmeal

Generic: oatmeal

Labeler: theraplex, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name theraplex eczema therapy moisturizing skin protectant with colloidal oatmeal
Generic Name oatmeal
Labeler theraplex, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

oatmeal 10 mg/g

Manufacturer
THERAPLEX, LLC

Identifiers & Regulatory

Product NDC 82280-618
Product ID 82280-618_375d2a1b-2049-cb83-e063-6394a90ae202
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2025-06-04

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 82280618
Hyphenated Format 82280-618

Supplemental Identifiers

RxCUI
240651
UPC
0855737001178
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 theraplex eczema therapy moisturizing skin protectant with colloidal oatmeal (source: ndc)
Generic Name oatmeal (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 85.05 g in 1 JAR (82280-618-00)
source: ndc

Packages (1)

82280-618-00 85.05 g in 1 JAR (82280-618-00)

Ingredients (1)

oatmeal (10 mg/g)

Linked Drug Pages (1)

THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "375d2a1b-2049-cb83-e063-6394a90ae202", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "upc": ["0855737001178"], "unii": ["8PI54V663Y"], "rxcui": ["240651"], "spl_set_id": ["e51aa467-ffe7-4c6b-8588-6df8592596d4"], "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": ["THERAPLEX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "85.05 g in 1 JAR (82280-618-00)", "package_ndc": "82280-618-00", "marketing_start_date": "20250604"}], "brand_name": "THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal", "product_id": "82280-618_375d2a1b-2049-cb83-e063-6394a90ae202", "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": "82280-618", "generic_name": "OATMEAL", "labeler_name": "THERAPLEX, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal", "active_ingredients": [{"name": "OATMEAL", "strength": "10 mg/g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250604", "listing_expiration_date": "20261231"}