Dextromethorphan HBr. and Guaifenesin NDC 84415-011

NDC codes

FDA NDC Directory

Product NDC (as listed)84415-011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84415-0011Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
84415-011-01	84415001101	100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-011-01) / 10 mL in 1 CUP, UNIT-DOSEMarketed from Jun 12, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Dextromethorphan HBr. and Guaifenesin
Generic name (nonproprietary): dextromethorphan hbr. and guaifenesin
Active ingredients: Dextromethorphan hydrobromide — 20 mg/10mLGuaifenesin — 200 mg/10mL
Dosage form: Solution
Route: Oral
Labeler: Everpharm LLC
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M012.85
Marketing start: Jun 12, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 84415-011_2bda25ff-9e45-8f8d-e063-6294a90a6a0fSPL ID 2bda25ff-9e45-8f8d-e063-6294a90a6a0fSPL set ID 0c7cd5c4-459d-4e42-ae22-b94f2e29cffbRxCUI 996520UNII 9D2RTI9KYH, 495W7451VQ
Pharmacologic class: Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N484415001101 followed by a unit qualifier and the quantity

Package 84415-0011-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 16, 2025.

Indications (excerpt from the label)

Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under M012.85

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M012.85
Product	Strength	Form · route	Labeler	Product NDC
Dextromethorphan HBr. and Guaifenesin	Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-313
Dextromethorphan HBr. and Guaifenesin	Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-312