TheraSeal

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: TheraSeal
Generic name: DIMETHICONE
Manufacturer: Bausch Health US, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 2c8dc616-20c1-4d33-8a89-9bcdb22b35c8
SPL ID: 24ade6cc-c3b3-2d87-e063-6394a90afc61
Version: 4
Effective date: 2024-10-17
Source export date: 2026-10-27
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:16:59

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M014	openfda.application_number
brand name		TheraSeal	openfda.brand_name
generic name		DIMETHICONE	openfda.generic_name
manufacturer name		Bausch Health US, LLC	openfda.manufacturer_name
ndc	package	0187-1660-06	openfda.package_ndc
ndc	product	0187-1660	openfda.product_ndc
ndc11	package	00187166006	derived:openfda.package_ndc
rxcui		200010	openfda.rxcui
rxcui		826807	openfda.rxcui
spl id		24ade6cc-c3b3-2d87-e063-6394a90afc61	id
spl set id		2c8dc616-20c1-4d33-8a89-9bcdb22b35c8	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 use only. When using this product avoid contact with eyes. Not to be applied over deep or puncture wounds, infections or lacerations. If condition worsens or does not improve within 7 days, consult a physician. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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