cough and cold xl3 xtra

Generic: acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide 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 cough and cold xl3 xtra
Generic Name acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride
Labeler selder, s.a. de c.v.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

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

Identifiers & Regulatory

Product NDC 63654-800
Product ID 63654-800_24b2193a-79ff-3792-e063-6394a90ad104
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2011-11-15

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 63654800
Hyphenated Format 63654-800

Supplemental Identifiers

RxCUI
1193292
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 cough and cold xl3 xtra (source: ndc)
Generic Name acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 2 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-06)
  • 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-12)
source: ndc

Packages (2)

63654-800-06 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-06) 63654-800-12 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-12)

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)

Cough and Cold XL3 Xtra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "24b2193a-79ff-3792-e063-6394a90ad104", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1193292"], "spl_set_id": ["da5b31dd-becd-471a-9392-d0ee4b8f9539"], "manufacturer_name": ["Selder, S.A. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-06)", "package_ndc": "63654-800-06", "marketing_start_date": "20181015"}, {"sample": false, "description": "12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-12)", "package_ndc": "63654-800-12", "marketing_start_date": "20140822"}], "brand_name": "Cough and Cold XL3 Xtra", "product_id": "63654-800_24b2193a-79ff-3792-e063-6394a90ad104", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "63654-800", "generic_name": "Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride", "labeler_name": "Selder, S.A. de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cough and Cold", "brand_name_suffix": "XL3 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": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20111115", "listing_expiration_date": "20261231"}