Guaifenesin and Dextromethorphan HBr

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: Guaifenesin and Dextromethorphan HBr
Generic name: GUAIFENESIN AND DEXTROMETHORPHAN HBR
Manufacturer: Aurohealth LLC
Product type: HUMAN OTC DRUG
SPL set ID: 88bc399a-2b71-45a7-bdfb-226ff1df0536
SPL ID: 72b8f474-79ca-4eaf-a036-8596d9ee9b2f
Version: 8
Effective date: 2026-01-30
Source export date: 2026-10-27
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/2026-10-27/d7629e6f844435cfe6cb0cf8c5341c46775ea16c5af42c77a22a2ffe820a2cd2/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:52:15

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 · 21 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	206941	derived:openfda.application_number
application number		ANDA206941	openfda.application_number
brand name		Guaifenesin and Dextromethorphan HBr	openfda.brand_name
generic name		GUAIFENESIN AND DEXTROMETHORPHAN HBR	openfda.generic_name
manufacturer name		Aurohealth LLC	openfda.manufacturer_name
ndc	package	58602-849-64	openfda.package_ndc
ndc	package	58602-849-15	openfda.package_ndc
ndc	package	58602-849-11	openfda.package_ndc
ndc	package	58602-849-65	openfda.package_ndc
ndc	package	58602-849-57	openfda.package_ndc
ndc	product	58602-849	openfda.product_ndc
ndc11	package	58602084965	derived:openfda.package_ndc
ndc11	package	58602084957	derived:openfda.package_ndc
ndc11	package	58602084964	derived:openfda.package_ndc
ndc11	package	58602084915	derived:openfda.package_ndc
ndc11	package	58602084911	derived:openfda.package_ndc
rxcui		1099074	openfda.rxcui
spl id		72b8f474-79ca-4eaf-a036-8596d9ee9b2f	id
spl set id		88bc399a-2b71-45a7-bdfb-226ff1df0536	set_id
unii		9D2RTI9KYH	openfda.unii
unii		495W7451VQ	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 for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, 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, ask a doctor or pharmacist before taking this product.

Reported adverse events (FAERS/openFDA)#

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