childrens cold cough and sore throat mixed berry

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler: aptapharma inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens cold cough and sore throat mixed berry
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler aptapharma inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
AptaPharma Inc.

Identifiers & Regulatory

Product NDC 76281-519
Product ID 76281-519_2f25ce5a-4e46-4e77-be6d-041a502a5049
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-01-30

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 76281519
Hyphenated Format 76281-519

Supplemental Identifiers

RxCUI
1593450
UNII
362O9ITL9D 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 childrens cold cough and sore throat mixed berry (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/10mL
  • 10 mg/10mL
  • 200 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (76281-519-24) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

76281-519-24 1 BOTTLE in 1 CARTON (76281-519-24) / 118 mL in 1 BOTTLE

Ingredients (4)

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

Linked Drug Pages (1)

CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f25ce5a-4e46-4e77-be6d-041a502a5049", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1593450"], "spl_set_id": ["5962a73e-72e4-493b-94a7-43bc6cf9c82f"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["AptaPharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76281-519-24)  / 118 mL in 1 BOTTLE", "package_ndc": "76281-519-24", "marketing_start_date": "20240130"}], "brand_name": "CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY", "product_id": "76281-519_2f25ce5a-4e46-4e77-be6d-041a502a5049", "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": "76281-519", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCL", "labeler_name": "AptaPharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240130", "listing_expiration_date": "20261231"}