broncochem kids cold and flu

Generic: acetaminophen-phenylephrine hcl-guaifenesin

Labeler: laboratorio magnachem international srl
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name broncochem kids cold and flu
Generic Name acetaminophen-phenylephrine hcl-guaifenesin
Labeler laboratorio magnachem international srl
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/10mL, guaifenesin 200 mg/10mL, phenylephrine hydrochloride 5 mg/10mL

Manufacturer
LABORATORIO MAGNACHEM INTERNATIONAL SRL

Identifiers & Regulatory

Product NDC 65131-054
Product ID 65131-054_7ec85034-cc70-4465-bc25-9c700731eb02
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part341
Listing Expiration 2026-12-31
Marketing Start 2017-05-01

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 65131054
Hyphenated Format 65131-054

Supplemental Identifiers

RxCUI
1116568
UPC
0805418098447
UNII
362O9ITL9D 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 broncochem kids cold and flu (source: ndc)
Generic Name acetaminophen-phenylephrine hcl-guaifenesin (source: ndc)
Application Number part341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/10mL
  • 200 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (65131-054-18) / 120 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

65131-054-18 1 BOTTLE, PLASTIC in 1 BOX (65131-054-18) / 120 mL in 1 BOTTLE, PLASTIC

Ingredients (3)

acetaminophen (325 mg/10mL) guaifenesin (200 mg/10mL) phenylephrine hydrochloride (5 mg/10mL)

Linked Drug Pages (1)

BRONCOCHEM KIDS COLD AND FLU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7ec85034-cc70-4465-bc25-9c700731eb02", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0805418098447"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116568"], "spl_set_id": ["523561fb-f6a7-4cde-9be2-bba02e60e208"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["LABORATORIO MAGNACHEM INTERNATIONAL SRL"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (65131-054-18)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65131-054-18", "marketing_start_date": "20170501"}], "brand_name": "BRONCOCHEM KIDS COLD AND FLU", "product_id": "65131-054_7ec85034-cc70-4465-bc25-9c700731eb02", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "65131-054", "generic_name": "ACETAMINOPHEN-PHENYLEPHRINE HCl-GUAIFENESIN", "labeler_name": "LABORATORIO MAGNACHEM INTERNATIONAL SRL", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BRONCOCHEM", "brand_name_suffix": "KIDS COLD AND FLU", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "part341", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20170501", "listing_expiration_date": "20261231"}