What is NDC 68788-8361?

68788-8361 is the product NDC for Guaifenesin and Codeine Phosphate, Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL solution, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Guaifenesin, Codeine phosphate.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Guaifenesin and Codeine Phosphate?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Guaifenesin and Codeine Phosphate NDC 68788-8361

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8361Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8361Add 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
68788-8361-1	68788836101	118 mL in 1 BOTTLE (68788-8361-1)Marketed from Feb 1, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Guaifenesin and Codeine Phosphate
Generic name (nonproprietary): guaifenesin and codeine phosphate
Active ingredients: Guaifenesin — 100 mg/5mLCodeine phosphate — 10 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication MO 12
Marketing start: Feb 1, 2023
Listing expires: Dec 31, 2026
DEA schedule: CV
Other FDA classes: Decreased Respiratory Secretion Viscosity (Physiologic effect)Full Opioid Agonists (Mechanism)Increased Respiratory Secretions (Physiologic effect)
Identifiers: Product ID 68788-8361_09ad5feb-c680-4634-8790-ab23bf0b8336SPL ID 09ad5feb-c680-4634-8790-ab23bf0b8336SPL set ID f5265ae5-db8e-428d-90e9-5eda6a8a22bdRxCUI 995868UNII 495W7451VQ, GSL05Y1MN6
Pharmacologic class: Expectorant; Opioid Agonist

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

N468788836101 followed by a unit qualifier and the quantity

Package 68788-8361-01. 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 Jun 16, 2025.

Indications (excerpt from the label)

Uses • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8361

What is NDC 68788-8361?: 68788-8361 is the product NDC for Guaifenesin and Codeine Phosphate, Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL solution, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Guaifenesin and Codeine Phosphate.
What is the active ingredient?: Guaifenesin, Codeine phosphate.
Who is the labeler?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Guaifenesin and Codeine Phosphate?: 5 other product NDCs are listed under this name. See all Guaifenesin and Codeine Phosphate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Guaifenesin and Codeine Phosphate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Guaifenesin and Codeine Phosphate	Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL	SolutionOral	Cardinal Health 107, LLC	55154-5791	55154-5791-05
Guaifenesin and Codeine Phosphate	Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL	SolutionOral	PAI Holdings, LLC	0121-0775	00121-0775-0400121-0775-16
Guaifenesin and Codeine Phosphate	Guaifenesin 200 mg/10mL; Codeine phosphate 20 mg/10mL	SolutionOral	PAI Holdings, LLC	0121-1550	00121-1550-0000121-1550-40
Guaifenesin and Codeine Phosphate	Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL	SolutionOral	PAI Holdings, LLC	0121-1775	00121-1775-0000121-1775-1000121-1775-40
Guaifenesin and Codeine Phosphate	Guaifenesin 100 mg/5mL; Codeine phosphate 10 mg/5mL	SolutionOral	A-S Medication Solutions	50090-1428	50090-1428-00

Other NDCs under MO 12

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

FDA NDC Directory listings under MO 12
Product	Strength	Form · route	Labeler	Product NDC
Geri-Dryl allergy reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-8104