baczol cold medicine

Generic: acetaminophen, dextromethorphan hbr, chlorpheniramine maleate, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name baczol cold medicine
Generic Name acetaminophen, dextromethorphan hbr, chlorpheniramine maleate, phenylephrine hcl
Labeler procaps s.a. de c.v.
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/5mL, chlorpheniramine maleate 4 mg/5mL, dextromethorphan hydrobromide 10 mg/5mL, phenylephrine hydrochloride 10 mg/5mL

Manufacturer
Procaps S.A. de C.V.

Identifiers & Regulatory

Product NDC 76864-208
Product ID 76864-208_2a45dc86-5be1-b1a4-e063-6394a90ae5df
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-05-25

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 76864208
Hyphenated Format 76864-208

Supplemental Identifiers

RxCUI
1370440
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 baczol cold medicine (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, chlorpheniramine maleate, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
  • 4 mg/5mL
  • 10 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (76864-208-01) / 120 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

76864-208-01 1 BOTTLE, PLASTIC in 1 CARTON (76864-208-01) / 120 mL in 1 BOTTLE, PLASTIC

Ingredients (4)

acetaminophen (250 mg/5mL) chlorpheniramine maleate (4 mg/5mL) dextromethorphan hydrobromide (10 mg/5mL) phenylephrine hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

BACZOL COLD MEDICINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a45dc86-5be1-b1a4-e063-6394a90ae5df", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1370440"], "spl_set_id": ["9d07b895-27ff-48b4-a597-29782a67a201"], "manufacturer_name": ["Procaps S.A. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76864-208-01)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76864-208-01", "marketing_start_date": "20200525"}], "brand_name": "BACZOL COLD MEDICINE", "product_id": "76864-208_2a45dc86-5be1-b1a4-e063-6394a90ae5df", "dosage_form": "SYRUP", "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": "76864-208", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HBr, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCl", "labeler_name": "Procaps S.A. de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BACZOL COLD MEDICINE", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/5mL"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "4 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200525", "listing_expiration_date": "20261231"}