EXTRA STRENGTH BODY

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: EXTRA STRENGTH BODY
Generic name: COLLOIDAL OATMEAL
Manufacturer: Skinfix, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 32ba5f29-c037-44dd-b5b1-59001ac50753
SPL ID: 471aacb1-39a1-1773-e063-6394a90ad389
Version: 7
Effective date: 2025-12-29
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:55:14

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		EXTRA STRENGTH BODY	openfda.brand_name
generic name		COLLOIDAL OATMEAL	openfda.generic_name
manufacturer name		Skinfix, Inc.	openfda.manufacturer_name
ndc	package	61328-119-28	openfda.package_ndc
ndc	product	61328-119	openfda.product_ndc
ndc11	package	61328011928	derived:openfda.package_ndc
rxcui		1189915	openfda.rxcui
spl id		471aacb1-39a1-1773-e063-6394a90ad389	id
spl set id		32ba5f29-c037-44dd-b5b1-59001ac50753	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, avoid contact with 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. When using this product Avoid contact with 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

Reported adverse events (FAERS/openFDA)#

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