Mucolyte DM

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 DM
Generic name: GUAIFENESIN, DEXTROMETHORPHAN HBR
Manufacturer: Rising Pharma Holdings, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: c913d27d-bc00-4ace-9a5f-c55522e1cd1d
SPL ID: e0d8faa2-7ca9-49c9-bae0-138fea576c68
Version: 1
Effective date: 2025-12-08
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:26:32

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Mucolyte DM	openfda.brand_name
generic name		GUAIFENESIN, DEXTROMETHORPHAN HBR	openfda.generic_name
manufacturer name		Rising Pharma Holdings, Inc.	openfda.manufacturer_name
ndc	package	57237-360-16	openfda.package_ndc
ndc	package	57237-360-12	openfda.package_ndc
ndc	product	57237-360	openfda.product_ndc
ndc11	package	57237036012	derived:openfda.package_ndc
ndc11	package	57237036016	derived:openfda.package_ndc
rxcui		996520	openfda.rxcui
spl id		e0d8faa2-7ca9-49c9-bae0-138fea576c68	id
spl set id		c913d27d-bc00-4ace-9a5f-c55522e1cd1d	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 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. Do not use if you have 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.