Baczol Expectorant Syrup
NDC Package 76864-209-02
Package Information
Baczol Expectorant (guaifenesin, phenylephrine hcl) syrups is uses • helps loosen phlegm (mucus) and thin bronchial secretions to drainbronchial tubes • temporarily relieves nasal congestion due to the common cold. This formulation utilizes a syrup delivery system. Marketed by Procaps S.a. De C.v., this product is identified by NDC 76864-209 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1370427 - guaiFENesin 200 MG / phenylephrine hydrochloride 5 MG in 5 mL Oral Solution
- RxCUI: 1370427 - guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution
- RxCUI: 1370427 - guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral Solution
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 76864 - Procaps S.a. De C.v.
- 76864-209 - Baczol Expectorant
- 76864-209-02 - 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC
- 76864-209 - Baczol Expectorant
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 76864-209-02 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 120 ml in 1 bottle, plastic of Baczol Expectorant, a human over the counter drug labeled by Procaps S.a. De C.v.. This syrup is formulated for oral use and contains guaifenesin; phenylephrine hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Procaps S.a. De C.v. on June 03, 2021. The current certification is valid through December 31, 2026.
How is this Procaps S.a. De C.v. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 76864020902. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.