sanaflu xtra

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

Labeler: grandall distributing, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sanaflu xtra
Generic Name acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
Labeler grandall distributing, llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, chlorpheniramine maleate 2 mg/1, dextromethorphan hydrobromide 10 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
GRANDALL DISTRIBUTING, LLC

Identifiers & Regulatory

Product NDC 48201-001
Product ID 48201-001_42404180-fa1a-fcf6-e063-6394a90a281f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2015-04-30

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 48201001
Hyphenated Format 48201-001

Supplemental Identifiers

RxCUI
1193292
UPC
0348201018142
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 sanaflu xtra (source: ndc)
Generic Name acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 2 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 12 CAPSULE, GELATIN COATED in 1 BOX (48201-001-12)
source: ndc

Packages (1)

48201-001-12 12 CAPSULE, GELATIN COATED in 1 BOX (48201-001-12)

Ingredients (4)

acetaminophen (250 mg/1) chlorpheniramine maleate (2 mg/1) dextromethorphan hydrobromide (10 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Sanaflu Xtra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42404180-fa1a-fcf6-e063-6394a90a281f", "openfda": {"upc": ["0348201018142"], "unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1193292"], "spl_set_id": ["4af8a566-5251-4d46-8692-87a3a0748334"], "manufacturer_name": ["GRANDALL DISTRIBUTING, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 CAPSULE, GELATIN COATED in 1 BOX (48201-001-12)", "package_ndc": "48201-001-12", "marketing_start_date": "20150430"}], "brand_name": "Sanaflu Xtra", "product_id": "48201-001_42404180-fa1a-fcf6-e063-6394a90a281f", "dosage_form": "CAPSULE, GELATIN COATED", "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": "48201-001", "generic_name": "ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "GRANDALL DISTRIBUTING, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sanaflu Xtra", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "2 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150430", "listing_expiration_date": "20261231"}