baczol expectorant

Generic: guaifenesin, 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 expectorant
Generic Name guaifenesin, phenylephrine hcl
Labeler procaps s.a. de c.v.
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

guaifenesin 200 mg/5mL, phenylephrine hydrochloride 5 mg/5mL

Manufacturer
Procaps S.A. de C.V.

Identifiers & Regulatory

Product NDC 76864-209
Product ID 76864-209_2a4622c1-eef5-28e2-e063-6294a90abbfa
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-06-03

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 76864209
Hyphenated Format 76864-209

Supplemental Identifiers

RxCUI
1370427
UNII
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 baczol expectorant (source: ndc)
Generic Name guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (76864-209-02) / 120 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

76864-209-02 1 BOTTLE, PLASTIC in 1 CARTON (76864-209-02) / 120 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

guaifenesin (200 mg/5mL) phenylephrine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

BACZOL EXPECTORANT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a4622c1-eef5-28e2-e063-6294a90abbfa", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ", "04JA59TNSJ"], "rxcui": ["1370427"], "spl_set_id": ["8e928b79-2178-47ef-8427-6bb57f143261"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Procaps S.A. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76864-209-02)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76864-209-02", "marketing_start_date": "20210603"}], "brand_name": "BACZOL EXPECTORANT", "product_id": "76864-209_2a4622c1-eef5-28e2-e063-6294a90abbfa", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "76864-209", "generic_name": "GUAIFENESIN, PHENYLEPHRINE HCl", "labeler_name": "Procaps S.A. de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BACZOL EXPECTORANT", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "200 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210603", "listing_expiration_date": "20261231"}