What is NDC 0031-8765?

0031-8765 is the product NDC for Robitussin Maximum Strength 12 Hour Cough and Mucus Relief, Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Haleon US Holdings LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Robitussin Maximum Strength 12 Hour Cough and Mucus Relief (Dextromethorphan Hydrobromide, Guaifenesin).

What is the active ingredient?

Dextromethorphan hydrobromide, Guaifenesin.

Haleon US Holdings LLC, NDC labeler code 0031. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Robitussin Maximum Strength 12 Hour Cough and Mucus Relief?

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 0031-8765

NDC codes

FDA NDC Directory

Product NDC (as listed)0031-8765Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00031-8765Add 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
0031-8765-04	0003187650400031876504	1 BLISTER PACK in 1 CARTON (0031-8765-04) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 14, 2019
0031-8765-08	0003187650800031876508	1 BLISTER PACK in 1 CARTON (0031-8765-08) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 14, 2019
0031-8765-16	0003187651600031876516	2 BLISTER PACK in 1 CARTON (0031-8765-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 14, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Robitussin Maximum Strength 12 Hour Cough and Mucus Relief
Generic name (nonproprietary): dextromethorphan hydrobromide, guaifenesin
Active ingredients: Dextromethorphan hydrobromide — 60 mg/1Guaifenesin — 1200 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Haleon US Holdings LLCNDC labeler code 0031
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207602
Marketing start: Jun 14, 2019
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 0031-8765_158a1612-05f6-cc2e-e063-6294a90ab9efSPL ID 158a1612-05f6-cc2e-e063-6294a90ab9efSPL set ID 96409b52-b0ec-444b-bc39-fd41070e9855RxCUI 1099074UNII 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

N400031876504 followed by a unit qualifier and the quantity

Package 00031-8765-04. 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 Apr 7, 2024.

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 0031-8765

What is NDC 0031-8765?: 0031-8765 is the product NDC for Robitussin Maximum Strength 12 Hour Cough and Mucus Relief, Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Haleon US Holdings LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Robitussin Maximum Strength 12 Hour Cough and Mucus Relief (Dextromethorphan Hydrobromide, Guaifenesin).
What is the active ingredient?: Dextromethorphan hydrobromide, Guaifenesin.
Who is the labeler?: Haleon US Holdings LLC, NDC labeler code 0031. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Robitussin Maximum Strength 12 Hour Cough and Mucus Relief?: 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 207602

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

FDA NDC Directory listings under ANDA 207602
Product	Strength	Form · route	Labeler	Product NDC
basic care mucus dmdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Amazon.com Services LLC	72288-812
Topcare Mucus DMdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Topco Associates LLC	36800-592
mucus dmdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Meijer Distribution Inc	41250-812
mucus dmdextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	HyVee Inc	42507-812
Rugby Mucus Relief DM ERdextromethorphan hydrobromide, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7891
Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	L. Perrigo Company	0113-2219
Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Sportpharm LLC	85766-172
Mucus Relief DMdextromethorphan hydrobromide, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-671
up and up mucus relief dmdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Target Corporation	11673-716
Good Neighbor Pharmacy Mucus DMdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Amerisource Bergen	46122-817
Berkley and Jensen Mucus Relief DMdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	BJWC	68391-812
mucus dm extended releaseguaifenesin, dextromethorphan hbr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	CVS Pharmacy	69842-812
members mark mucus relief dmdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Sam's West Inc	68196-812
mucus relief dmdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Meijer Distribution Inc	41250-436
kirkland signature mucus dmdextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Costco Wholesale Company	63981-812
Topcare Mucus DMdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Topco Associates LLC	36800-219
equaline mucus dmdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	United Natural Foods, Inc. dba UNFI	41163-599
Mucus DM Maxdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Amazon.com Services LLC	72288-420
Rugby Mucus Relief DM ERdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Rugby Laboratories	0536-1446
Mucus Relief DMdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Walgreen Company	0363-3219

Showing 20 of 36.

Robitussin Maximum Strength 12 Hour Cough and Mucus Relief NDC 0031-8765