childrens delsym cough plus chest congestion dm

Generic: dextromethorphan hydrobromide and guaifenesin

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens delsym cough plus chest congestion dm
Generic Name dextromethorphan hydrobromide and guaifenesin
Labeler rb health (us) llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-214
Product ID 63824-214_1bf80730-b2e0-9f0e-e063-6394a90a480a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2013-03-31

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63824214
Hyphenated Format 63824-214

Supplemental Identifiers

RxCUI
1020138
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name childrens delsym cough plus chest congestion dm (source: ndc)
Generic Name dextromethorphan hydrobromide and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63824-214-64) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

63824-214-64 1 BOTTLE in 1 CARTON (63824-214-64) / 118 mL in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (5 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

Childrens Delsym Cough Plus Chest Congestion DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1bf80730-b2e0-9f0e-e063-6394a90a480a", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1020138"], "spl_set_id": ["d26b5143-aa07-4114-a6ba-4f503aadd46f"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63824-214-64)  / 118 mL in 1 BOTTLE", "package_ndc": "63824-214-64", "marketing_start_date": "20170608"}], "brand_name": "Childrens Delsym Cough Plus Chest Congestion DM", "product_id": "63824-214_1bf80730-b2e0-9f0e-e063-6394a90a480a", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "63824-214", "generic_name": "Dextromethorphan Hydrobromide and Guaifenesin", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Delsym", "brand_name_suffix": "Cough Plus Chest Congestion DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130331", "listing_expiration_date": "20261231"}