cetaphil baby eczema soothing

Generic: colloidal oatmeal

Labeler: galderma laboratories, l.p.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cetaphil baby eczema soothing
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 0299-4140
Product ID 0299-4140_bfe4854f-7c69-4d6a-8663-adc49f3bec83
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2018-05-01

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 02994140
Hyphenated Format 0299-4140

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 baby eczema soothing (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
  • 147 mL in 1 BOTTLE, PUMP (0299-4140-05)
  • 296 mL in 1 BOTTLE, PUMP (0299-4140-10)
source: ndc

Packages (2)

0299-4140-05 147 mL in 1 BOTTLE, PUMP (0299-4140-05) 0299-4140-10 296 mL in 1 BOTTLE, PUMP (0299-4140-10)

Ingredients (1)

oatmeal (1 g/100mL)

Linked Drug Pages (1)

Cetaphil Baby Eczema Soothing ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "bfe4854f-7c69-4d6a-8663-adc49f3bec83", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "unii": ["8PI54V663Y"], "rxcui": ["240464"], "spl_set_id": ["d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b"], "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": "147 mL in 1 BOTTLE, PUMP (0299-4140-05)", "package_ndc": "0299-4140-05", "marketing_start_date": "20180501"}, {"sample": false, "description": "296 mL in 1 BOTTLE, PUMP (0299-4140-10)", "package_ndc": "0299-4140-10", "marketing_start_date": "20190722"}], "brand_name": "Cetaphil Baby Eczema Soothing", "product_id": "0299-4140_bfe4854f-7c69-4d6a-8663-adc49f3bec83", "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": "0299-4140", "generic_name": "colloidal oatmeal", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetaphil Baby Eczema Soothing", "active_ingredients": [{"name": "OATMEAL", "strength": "1 g/100mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180501", "listing_expiration_date": "20261231"}