What is NDC 67091-315?

67091-315 is the product NDC for Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength, Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 tablet, extended release, listed with the FDA by Winco Foods, LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength (Guaifenesin and Dextromethorphan HBr).

What is the active ingredient?

Guaifenesin, Dextromethorphan hydrobromide.

Winco Foods, LLC., NDC labeler code 67091. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 67091-315

NDC codes

FDA NDC Directory

Product NDC (as listed)67091-315Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67091-0315Add 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
67091-315-14	6709103151467091031514	2 CARTON in 1 CARTON (67091-315-14) / 7 TABLET, EXTENDED RELEASE in 1 CARTONMarketed from Mar 17, 2017

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): Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength
Generic name (nonproprietary): guaifenesin and dextromethorphan hbr
Active ingredients: Guaifenesin — 1200 mg/1Dextromethorphan hydrobromide — 60 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Winco Foods, LLC.NDC labeler code 67091
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206941
Marketing start: Mar 17, 2017
Listing expires: Dec 31, 2027
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 67091-315_b6b1e266-1ff8-4a43-b9b5-dfe69ac5559bSPL ID b6b1e266-1ff8-4a43-b9b5-dfe69ac5559bSPL set ID ac1c8633-4064-4e2f-9b43-4ae9bdd1a427RxCUI 1099074UNII 495W7451VQ, 9D2RTI9KYH
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

N467091031514 followed by a unit qualifier and the quantity

Package 67091-0315-14. 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 Dec 1, 2023.

Indications (excerpt from the label)

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67091-315

What is NDC 67091-315?: 67091-315 is the product NDC for Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength, Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 tablet, extended release, listed with the FDA by Winco Foods, LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength (Guaifenesin and Dextromethorphan HBr).
What is the active ingredient?: Guaifenesin, Dextromethorphan hydrobromide.
Who is the labeler?: Winco Foods, LLC., NDC labeler code 67091. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 206941

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

FDA NDC Directory listings under ANDA 206941
Product	Strength	Form · route	Labeler	Product NDC
Mucus Relief DMguaifenesin and dextromethorphan hbr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Harris Teeter	72036-980
Guaifenesin and Dextromethorphan HBr	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	KROGER COMPANY	30142-276
Guaifenesin and Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	INNOVUS PHARMACEUTICALS, INC.	57483-114
Guaifenesin and Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Target Corporation	11673-267
Guaifenesin And Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	TOPCO ASSOCIATES LLC	76162-032
Mucus Relief DMguaifenesin and dextromethorphan hbr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Ahold U.S.A., Inc,	60000-057
Mucus Relief DMguaifenesin and dextromethorphan hbr	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	Ahold U.S.A., Inc,	60000-058
Guaifenesin and Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	VESPYR BRANDS LLC	71179-011
Maximum Strength Mucus Relief DMguaifenesin and dextromethorphan hbr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	WALGREEN CO.	0363-0510
Mucus DMguaifenesin and dextromethorphan hbr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Amerisource Bergen	46122-420
Mucus Relief - DM Maximum Strengthguaifenesin, dextromethorphan hbr	Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1	TabletOral	YYBA CORP	73581-406
Guaifenesin and Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Sportpharm LLC	85766-046
Guaifenesin and Dextromethorphan HBr	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	Aurohealth LLC	58602-714
Guaifenesin and Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Aurohealth LLC	58602-715
Mucus Relief DM Expectorant and Cough Suppressantguaifenesin and dextromethorphan hbr	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	Winco Foods, LLC.	67091-314
Guaifenesin and Dextromethorphan HBr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	KROGER COMPANY	30142-275
Maximum Strength Mucus Relief DMguaifenesin and dextromethorphan hbr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Wal-Mart Stores, Inc.	49035-956
Mucus Relief DMguaifenesin and dextromethorphan hbr	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	Wal-Mart Stores, Inc.	49035-960
Mucus Relief DM MAXIMUM STRENGTHguaifenesin and dextromethorphan hbr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Better Living Brands LLC	21130-989
Mucus Relief DMguaifenesin and dextromethorphan hbr	Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1	Tablet, Extended releaseOral	Better Living Brands LLC	21130-997

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Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength (Guaifenesin and dextromethorphan hbr) NDC 67091-315