Dometuss

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: Dometuss
Generic name: CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
Manufacturer: Dextrum Laboratories, Inc
Product type: HUMAN OTC DRUG
SPL set ID: 3fcace53-a81f-e774-e063-6294a90a32fa
SPL ID: 3fcace53-a820-e774-e063-6294a90a32fa
Version: 1
Effective date: 2025-09-27
Source export date: 2026-10-27
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/55ffdfed5c29f1b4aed512886bd3fb7831e157cc4948137779971a558752ed2b/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:07:26

Harmonized routes table
Harmonized routes
ORAL

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		M012	openfda.application_number
brand name		Dometuss	openfda.brand_name
generic name		CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	openfda.generic_name
manufacturer name		Dextrum Laboratories, Inc	openfda.manufacturer_name
ndc	package	65852-002-04	openfda.package_ndc
ndc	product	65852-002	openfda.product_ndc
ndc11	package	65852000204	derived:openfda.package_ndc
rxcui		1363752	openfda.rxcui
spl id		3fcace53-a820-e774-e063-6294a90a32fa	id
spl set id		3fcace53-a81f-e774-e063-6294a90a32fa	set_id
unii		9D2RTI9KYH	openfda.unii
unii		04JA59TNSJ	openfda.unii
unii		V1Q0O9OJ9Z	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: Do not use To sedate a child or to make a child sleepy. If you are now taking a prescription monoamine oxidose inhibitor (MAOI) (Certain drugs for depression, psychiatric or emotional conditiosn or parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, asl a doctor or pharmacist before taking this product. Warning

Reported adverse events (FAERS/openFDA)#

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