GLADSKIN ECZEMACT ECZEMA

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: GLADSKIN ECZEMACT ECZEMA
Generic name: COLLOIDAL OATMEAL
Manufacturer: Micreos North America, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 06f9af75-c5ff-d37b-e063-6394a90a4f6c
SPL ID: 4ba8734b-a8bf-515e-e063-6394a90a892d
Version: 2
Effective date: 2026-02-25
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:27:21

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		GLADSKIN ECZEMACT ECZEMA	openfda.brand_name
generic name		COLLOIDAL OATMEAL	openfda.generic_name
manufacturer name		Micreos North America, Inc.	openfda.manufacturer_name
ndc	package	73105-003-50	openfda.package_ndc
ndc	package	73105-003-00	openfda.package_ndc
ndc	product	73105-003	openfda.product_ndc
ndc11	package	73105000350	derived:openfda.package_ndc
ndc11	package	73105000300	derived:openfda.package_ndc
rxcui		2267204	openfda.rxcui
spl id		4ba8734b-a8bf-515e-e063-6394a90a892d	id
spl set id		06f9af75-c5ff-d37b-e063-6394a90a4f6c	set_id
unii		8PI54V663Y	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. When using this product do not get into eyes. Stop use and ask a doctor if: Conditions worsen Symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children . If swallowed, get medical help or contact a poison control center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.