maximum strength cold and flu

Generic: acetaminophen,dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler: family dollar services
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name maximum strength cold and flu
Generic Name acetaminophen,dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler family dollar services
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
FAMILY DOLLAR SERVICES

Identifiers & Regulatory

Product NDC 55319-628
Product ID 55319-628_2e2c825a-b5bd-9b82-e063-6394a90aa88f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-08-24

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 55319628
Hyphenated Format 55319-628

Supplemental Identifiers

RxCUI
1656815
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 maximum strength cold and flu (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/1
  • 10 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (55319-628-16)
source: ndc

Packages (1)

55319-628-16 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (55319-628-16)

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

MAXIMUM STRENGTH COLD AND FLU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2e2c825a-b5bd-9b82-e063-6394a90aa88f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1656815"], "spl_set_id": ["a7343bea-53cc-4621-e053-2a95a90a2a5f"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["FAMILY DOLLAR SERVICES"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (55319-628-16)", "package_ndc": "55319-628-16", "marketing_start_date": "20200824"}], "brand_name": "MAXIMUM STRENGTH COLD AND FLU", "product_id": "55319-628_2e2c825a-b5bd-9b82-e063-6394a90aa88f", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "55319-628", "generic_name": "ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL", "labeler_name": "FAMILY DOLLAR SERVICES", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MAXIMUM STRENGTH COLD AND FLU", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200824", "listing_expiration_date": "20261231"}