altipres pediatric

Generic: dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler: advanced generic corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name altipres pediatric
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler advanced generic corporation
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 75 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
Advanced Generic Corporation

Identifiers & Regulatory

Product NDC 45737-105
Product ID 45737-105_472eca54-1c0a-770e-e063-6294a90a7e01
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

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 45737105
Hyphenated Format 45737-105

Supplemental Identifiers

RxCUI
1119541
UPC
0345737105162
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 altipres pediatric (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 75 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (45737-105-16)
source: ndc

Packages (1)

45737-105-16 473 mL in 1 BOTTLE (45737-105-16)

Ingredients (3)

dextromethorphan hydrobromide (5 mg/5mL) guaifenesin (75 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

Altipres Pediatric ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "472eca54-1c0a-770e-e063-6294a90a7e01", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0345737105162"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1119541"], "spl_set_id": ["2a336896-a2f8-2a0c-e063-6294a90ae03a"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Advanced Generic Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (45737-105-16)", "package_ndc": "45737-105-16", "marketing_start_date": "20241201"}], "brand_name": "Altipres Pediatric", "product_id": "45737-105_472eca54-1c0a-770e-e063-6294a90a7e01", "dosage_form": "LIQUID", "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": "45737-105", "generic_name": "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "Advanced Generic Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Altipres Pediatric", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "75 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}