Childrens Delsym Cough Plus Chest Congestion 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: Childrens Delsym Cough Plus Chest Congestion DM
Generic name: DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN
Manufacturer: Reckitt Benckiser LLC
Product type: HUMAN OTC DRUG
SPL set ID: d26b5143-aa07-4114-a6ba-4f503aadd46f
SPL ID: 52d107ce-dd04-515f-e063-6394a90a91dc
Version: 9
Effective date: 2026-05-27
Source export date: 2026-09-28
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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:55:38

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		Childrens Delsym Cough Plus Chest Congestion DM	openfda.brand_name
generic name		DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	openfda.generic_name
manufacturer name		Reckitt Benckiser LLC	openfda.manufacturer_name
ndc	package	63824-214-64	openfda.package_ndc
ndc	package	63824-214-66	openfda.package_ndc
ndc	product	63824-214	openfda.product_ndc
ndc11	package	63824021464	derived:openfda.package_ndc
ndc11	package	63824021466	derived:openfda.package_ndc
rxcui		1020138	openfda.rxcui
spl id		52d107ce-dd04-515f-e063-6394a90a91dc	id
spl set id		d26b5143-aa07-4114-a6ba-4f503aadd46f	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 in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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