THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal

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: THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal
Generic name: OATMEAL
Manufacturer: THERAPLEX, LLC
Product type: HUMAN OTC DRUG
SPL set ID: e51aa467-ffe7-4c6b-8588-6df8592596d4
SPL ID: 375d2a1b-2049-cb83-e063-6394a90ae202
Version: 1
Effective date: 2025-06-16
Source export date: 2026-11-06
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/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:02:37

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal	openfda.brand_name
generic name		OATMEAL	openfda.generic_name
manufacturer name		THERAPLEX, LLC	openfda.manufacturer_name
ndc	package	82280-618-00	openfda.package_ndc
ndc	product	82280-618	openfda.product_ndc
ndc11	package	82280061800	derived:openfda.package_ndc
rxcui		240651	openfda.rxcui
spl id		375d2a1b-2049-cb83-e063-6394a90ae202	id
spl set id		e51aa467-ffe7-4c6b-8588-6df8592596d4	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 condition worsens 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.