Bio-Z-Cough

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: Bio-Z-Cough
Generic name: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Manufacturer: Advanced Generic Corporation
Product type: HUMAN OTC DRUG
SPL set ID: 05e70eab-1467-4b09-991e-ef03f222e021
SPL ID: 47435899-03bb-ae43-e063-6394a90ad15a
Version: 7
Effective date: 2025-12-31
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:15:50

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Bio-Z-Cough	openfda.brand_name
generic name		DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	openfda.generic_name
manufacturer name		Advanced Generic Corporation	openfda.manufacturer_name
ndc	package	45737-251-16	openfda.package_ndc
ndc	product	45737-251	openfda.product_ndc
ndc11	package	45737025116	derived:openfda.package_ndc
rxcui		1113368	openfda.rxcui
spl id		47435899-03bb-ae43-e063-6394a90ad15a	id
spl set id		05e70eab-1467-4b09-991e-ef03f222e021	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: Ask a doctor before use if you have: cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema. When using this product do not use more than directed. Stop use and ask a doctor before use if: cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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