giltuss childrens multisymptom cold and flu

Generic: acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name giltuss childrens multisymptom cold and flu
Generic Name acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
Labeler giltuss pharmaceutical corp
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/5mL, chlorpheniramine maleate 2 mg/5mL, dextromethorphan hydrobromide 6.5 mg/5mL, phenylephrine hydrochloride 5 mg/5mL

Manufacturer
Giltuss Pharmaceutical Corp

Identifiers & Regulatory

Product NDC 58552-137
Product ID 58552-137_40b8865e-4141-75bb-e063-6394a90aafba
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-10-02

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] 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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58552137
Hyphenated Format 58552-137

Supplemental Identifiers

RxCUI
2121065
UNII
362O9ITL9D V1Q0O9OJ9Z 9D2RTI9KYH 04JA59TNSJ

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 multisymptom cold and flu (source: ndc)
Generic Name acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/5mL
  • 2 mg/5mL
  • 6.5 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58552-137-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

58552-137-04 1 BOTTLE in 1 CARTON (58552-137-04) / 118 mL in 1 BOTTLE

Ingredients (4)

acetaminophen (325 mg/5mL) chlorpheniramine maleate (2 mg/5mL) dextromethorphan hydrobromide (6.5 mg/5mL) phenylephrine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Giltuss Childrens MultiSymptom Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40b8865e-4141-75bb-e063-6394a90aafba", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["2121065"], "spl_set_id": ["852c8cd6-271f-0fa8-e053-2991aa0ab179"], "manufacturer_name": ["Giltuss Pharmaceutical Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58552-137-04)  / 118 mL in 1 BOTTLE", "package_ndc": "58552-137-04", "marketing_start_date": "20181002"}], "brand_name": "Giltuss Childrens MultiSymptom Cold and Flu", "product_id": "58552-137_40b8865e-4141-75bb-e063-6394a90aafba", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "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": "58552-137", "generic_name": "Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride", "labeler_name": "Giltuss Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Childrens MultiSymptom Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/5mL"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "2 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "6.5 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181002", "listing_expiration_date": "20261231"}