cold medicine xl3 forte

Generic: acetaminophen chlorpheniramine maleate phenylepherine hydrochloride

Labeler: selder, s.a. de c.v.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cold medicine xl3 forte
Generic Name acetaminophen chlorpheniramine maleate phenylepherine hydrochloride
Labeler selder, s.a. de c.v.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, chlorpheniramine maleate 4 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Selder, S.A. de C.V.

Identifiers & Regulatory

Product NDC 63654-601
Product ID 63654-601_24b211e4-a9aa-47a2-e063-6394a90aa4d3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2017-08-01

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63654601
Hyphenated Format 63654-601

Supplemental Identifiers

RxCUI
1193293
UNII
362O9ITL9D V1Q0O9OJ9Z 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 cold medicine xl3 forte (source: ndc)
Generic Name acetaminophen chlorpheniramine maleate phenylepherine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 4 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 BOX (63654-601-10) / 10 TABLET in 1 BLISTER PACK (63654-601-01)
  • 2 BLISTER PACK in 1 BOX (63654-601-20) / 10 TABLET in 1 BLISTER PACK (63654-601-02)
  • 50 PACKET in 1 BOX (63654-601-50) / 4 TABLET in 1 PACKET (63654-601-04)
source: ndc

Packages (3)

63654-601-10 1 BLISTER PACK in 1 BOX (63654-601-10) / 10 TABLET in 1 BLISTER PACK (63654-601-01) 63654-601-20 2 BLISTER PACK in 1 BOX (63654-601-20) / 10 TABLET in 1 BLISTER PACK (63654-601-02) 63654-601-50 50 PACKET in 1 BOX (63654-601-50) / 4 TABLET in 1 PACKET (63654-601-04)

Ingredients (3)

acetaminophen (325 mg/1) chlorpheniramine maleate (4 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cold Medicine XL3 FORTE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "24b211e4-a9aa-47a2-e063-6394a90aa4d3", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "04JA59TNSJ"], "rxcui": ["1193293"], "spl_set_id": ["51dd467b-aae8-41fa-e054-00144ff8d46c"], "manufacturer_name": ["Selder, S.A. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 BOX (63654-601-10)  / 10 TABLET in 1 BLISTER PACK (63654-601-01)", "package_ndc": "63654-601-10", "marketing_start_date": "20181012"}, {"sample": false, "description": "2 BLISTER PACK in 1 BOX (63654-601-20)  / 10 TABLET in 1 BLISTER PACK (63654-601-02)", "package_ndc": "63654-601-20", "marketing_start_date": "20170801"}, {"sample": false, "description": "50 PACKET in 1 BOX (63654-601-50)  / 4 TABLET in 1 PACKET (63654-601-04)", "package_ndc": "63654-601-50", "marketing_start_date": "20170801"}], "brand_name": "Cold Medicine XL3 FORTE", "product_id": "63654-601_24b211e4-a9aa-47a2-e063-6394a90aa4d3", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "63654-601", "generic_name": "Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride", "labeler_name": "Selder, S.A. de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold Medicine", "brand_name_suffix": "XL3 FORTE", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "4 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170801", "listing_expiration_date": "20261231"}