avene xeracalm eczema calming relief balm

Generic: colloidal oatmeal

Labeler: pierre fabre usa inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name avene xeracalm eczema calming relief balm
Generic Name colloidal oatmeal
Labeler pierre fabre usa inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

oatmeal 1 g/100g

Manufacturer
Pierre Fabre USA Inc.

Identifiers & Regulatory

Product NDC 64760-777
Product ID 64760-777_26443c1f-2af2-eaf3-e063-6294a90acf57
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

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 64760777
Hyphenated Format 64760-777

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 avene xeracalm eczema calming relief balm (source: ndc)
Generic Name colloidal oatmeal (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 100 g in 1 TUBE (64760-777-01)
  • 1 TUBE in 1 BOX (64760-777-02) / 5 g in 1 TUBE
source: ndc

Packages (2)

64760-777-01 100 g in 1 TUBE (64760-777-01) 64760-777-02 1 TUBE in 1 BOX (64760-777-02) / 5 g in 1 TUBE

Ingredients (1)

oatmeal (1 g/100g)

Linked Drug Pages (1)

Avene XERACALM Eczema Calming Relief Balm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "26443c1f-2af2-eaf3-e063-6294a90acf57", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "unii": ["8PI54V663Y"], "rxcui": ["240651"], "spl_set_id": ["1315f006-0e96-2074-e063-6394a90a6037"], "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": ["Pierre Fabre USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 g in 1 TUBE (64760-777-01)", "package_ndc": "64760-777-01", "marketing_start_date": "20240501"}, {"sample": true, "description": "1 TUBE in 1 BOX (64760-777-02)  / 5 g in 1 TUBE", "package_ndc": "64760-777-02", "marketing_start_date": "20240603"}], "brand_name": "Avene XERACALM Eczema Calming Relief Balm", "product_id": "64760-777_26443c1f-2af2-eaf3-e063-6294a90acf57", "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": "64760-777", "generic_name": "Colloidal oatmeal", "labeler_name": "Pierre Fabre USA Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Avene XERACALM Eczema Calming Relief Balm", "active_ingredients": [{"name": "OATMEAL", "strength": "1 g/100g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}