childrens giltuss honey cough and chest congestion

Generic: dextromethorphan hbr, guaifenesin

Labeler: dextrum laboratories, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens giltuss honey cough and chest congestion
Generic Name dextromethorphan hbr, guaifenesin
Labeler dextrum laboratories, inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer
Dextrum Laboratories, Inc

Identifiers & Regulatory

Product NDC 65852-003
Product ID 65852-003_3f909bc2-eb85-a19d-e063-6294a90ae04e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-06-22

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 65852003
Hyphenated Format 65852-003

Supplemental Identifiers

RxCUI
996520
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 giltuss honey cough and chest congestion (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (65852-003-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

65852-003-04 1 BOTTLE, PLASTIC in 1 CARTON (65852-003-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

dextromethorphan hydrobromide (10 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

Childrens Giltuss Honey Cough and Chest Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f909bc2-eb85-a19d-e063-6294a90ae04e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["3f909bc2-eb84-a19d-e063-6294a90ae04e"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Dextrum Laboratories, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (65852-003-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65852-003-04", "marketing_start_date": "20200622"}], "brand_name": "Childrens Giltuss Honey Cough and Chest Congestion", "product_id": "65852-003_3f909bc2-eb85-a19d-e063-6294a90ae04e", "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": "65852-003", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "Dextrum Laboratories, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Giltuss Honey Cough and Chest Congestion", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200622", "listing_expiration_date": "20261231"}