giltuss childrens cough and cold

Generic: dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Labeler: gil pharmaceutical corp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name giltuss childrens cough and cold
Generic Name dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Labeler gil pharmaceutical corp
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 7.5 mg/2.5mL, guaifenesin 150 mg/2.5mL, phenylephrine hydrochloride 5 mg/2.5mL

Manufacturer
Gil Pharmaceutical Corp

Identifiers & Regulatory

Product NDC 58552-131
Product ID 58552-131_40b823a5-5359-e635-e063-6394a90a4283
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-11-07

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 58552131
Hyphenated Format 58552-131

Supplemental Identifiers

RxCUI
1251031
UNII
9D2RTI9KYH 495W7451VQ 04JA59TNSJ
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 giltuss childrens cough and cold (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/2.5mL
  • 150 mg/2.5mL
  • 5 mg/2.5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58552-131-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

58552-131-04 1 BOTTLE in 1 CARTON (58552-131-04) / 118 mL in 1 BOTTLE

Ingredients (3)

dextromethorphan hydrobromide (7.5 mg/2.5mL) guaifenesin (150 mg/2.5mL) phenylephrine hydrochloride (5 mg/2.5mL)

Linked Drug Pages (1)

Giltuss Childrens Cough and Cold ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40b823a5-5359-e635-e063-6394a90a4283", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1251031"], "spl_set_id": ["852b77ae-a5ac-3ead-e053-2a91aa0a54bd"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Gil Pharmaceutical Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58552-131-04)  / 118 mL in 1 BOTTLE", "package_ndc": "58552-131-04", "marketing_start_date": "20181107"}], "brand_name": "Giltuss Childrens Cough and Cold", "product_id": "58552-131_40b823a5-5359-e635-e063-6394a90a4283", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "58552-131", "generic_name": "Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride", "labeler_name": "Gil Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Childrens Cough and Cold", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "7.5 mg/2.5mL"}, {"name": "GUAIFENESIN", "strength": "150 mg/2.5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/2.5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181107", "listing_expiration_date": "20261231"}