cetaphil eczema soothing moisturizer (0299-4128)

Drug Facts

Product Profile

Brand Name cetaphil eczema soothing moisturizer

Generic Name colloidal oatmeal

Labeler galderma laboratories, l.p.

Dosage Form LOTION

Routes

TOPICAL

Active Ingredients

oatmeal 1 g/100mL

Manufacturer

Galderma Laboratories, L.P.

Identifiers & Regulatory

Product NDC 0299-4128

Product ID 0299-4128_a3c464d3-83b8-495e-bfef-369d23fae338

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M016

Listing Expiration 2026-12-31

Marketing Start 2022-05-01

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 02994128

Hyphenated Format 0299-4128

Supplemental Identifiers

RxCUI

240464

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 cetaphil eczema soothing moisturizer (source: ndc)

Generic Name colloidal oatmeal (source: ndc)

Application Number M016 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

1 g/100mL

source: ndc

Packaging

296 mL in 1 BOTTLE, PUMP (0299-4128-00)
29 mL in 1 BOTTLE (0299-4128-05)
473 mL in 1 BOTTLE, PUMP (0299-4128-10)

source: ndc

Packages (3)

0299-4128-00 296 mL in 1 BOTTLE, PUMP (0299-4128-00) 0299-4128-05 29 mL in 1 BOTTLE (0299-4128-05) 0299-4128-10 473 mL in 1 BOTTLE, PUMP (0299-4128-10)

Ingredients (1)

oatmeal (1 g/100mL)

Linked Drug Pages (1)

Cetaphil Eczema Soothing Moisturizer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "a3c464d3-83b8-495e-bfef-369d23fae338", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "unii": ["8PI54V663Y"], "rxcui": ["240464"], "spl_set_id": ["0d01c3fb-d420-484d-aae1-33234c9e383e"], "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": ["Galderma Laboratories, L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "296 mL in 1 BOTTLE, PUMP (0299-4128-00)", "package_ndc": "0299-4128-00", "marketing_start_date": "20220501"}, {"sample": false, "description": "29 mL in 1 BOTTLE (0299-4128-05)", "package_ndc": "0299-4128-05", "marketing_start_date": "20220501"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PUMP (0299-4128-10)", "package_ndc": "0299-4128-10", "marketing_start_date": "20240501"}], "brand_name": "Cetaphil Eczema Soothing Moisturizer", "product_id": "0299-4128_a3c464d3-83b8-495e-bfef-369d23fae338", "dosage_form": "LOTION", "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": "0299-4128", "generic_name": "colloidal oatmeal", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetaphil Eczema Soothing Moisturizer", "active_ingredients": [{"name": "OATMEAL", "strength": "1 g/100mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220501", "listing_expiration_date": "20261231"}