Mucolyte

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: Mucolyte
Generic name: GUAIFENESIN
Manufacturer: Rising Pharma Holdings, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: e4091aaf-44e3-4701-9986-aff248a2f1b8
SPL ID: ab35cca0-adaa-4e57-bd51-b29528cb8358
Version: 1
Effective date: 2025-12-08
Source export date: 2026-11-06
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:39:34

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		Mucolyte	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		Rising Pharma Holdings, Inc.	openfda.manufacturer_name
ndc	package	57237-359-16	openfda.package_ndc
ndc	package	57237-359-12	openfda.package_ndc
ndc	product	57237-359	openfda.product_ndc
ndc11	package	57237035912	derived:openfda.package_ndc
ndc11	package	57237035916	derived:openfda.package_ndc
rxcui		310604	openfda.rxcui
spl id		ab35cca0-adaa-4e57-bd51-b29528cb8358	id
spl set id		e4091aaf-44e3-4701-9986-aff248a2f1b8	set_id
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 if you ever had an allergic reaction to any of the ingredients in this product 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 Stop use and ask a doctor 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.