Comfort Shield Barrier

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: Comfort Shield Barrier
Generic name: DIMETHICONE
Manufacturer: Sage Products LLC
Product type: HUMAN OTC DRUG
SPL set ID: cc08f571-84ae-4c2f-b09d-a83a8efc39f5
SPL ID: 54ee06dc-1e51-3f8a-e063-6294a90a1fb0
Version: 17
Effective date: 2026-06-23
Source export date: 2026-10-30
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/e1583c3c823c7746dc6fefae78ac97d01bb558f7b0936fc3b7d2e673d3319207/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:35:42

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 · 22 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		Comfort Shield Barrier	openfda.brand_name
generic name		DIMETHICONE	openfda.generic_name
manufacturer name		Sage Products LLC	openfda.manufacturer_name
ndc	package	53462-915-51	openfda.package_ndc
ndc	package	53462-915-62	openfda.package_ndc
ndc	package	53462-915-80	openfda.package_ndc
ndc	package	53462-915-81	openfda.package_ndc
ndc	package	53462-915-50	openfda.package_ndc
ndc	package	53462-915-24	openfda.package_ndc
ndc	product	53462-915	openfda.product_ndc
ndc11	package	53462091550	derived:openfda.package_ndc
ndc11	package	53462091581	derived:openfda.package_ndc
ndc11	package	53462091524	derived:openfda.package_ndc
ndc11	package	53462091551	derived:openfda.package_ndc
ndc11	package	53462091580	derived:openfda.package_ndc
ndc11	package	53462091562	derived:openfda.package_ndc
rxcui		1088604	openfda.rxcui
rxcui		968663	openfda.rxcui
spl id		54ee06dc-1e51-3f8a-e063-6294a90a1fb0	id
spl set id		cc08f571-84ae-4c2f-b09d-a83a8efc39f5	set_id
unii		92RU3N3Y1O	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 perineal use only. Avoid contact with the eyes. Stop use and consult a doctor if condition worsens or does not improve within 7 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.