What is NDC 0031-8716?

0031-8716 is the product NDC for Childrens Robitussin Cough and Cold CF, Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients liquid, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Childrens Robitussin Cough and Cold CF (Dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride).

What is the active ingredient?

Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride.

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 Childrens Robitussin Cough and Cold CF?

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.

Childrens Robitussin Cough and Cold CF NDC 0031-8716

NDC codes

FDA NDC Directory

Product NDC (as listed)0031-8716Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00031-8716Add 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
0031-8716-12	0003187161200031871612	1 BOTTLE in 1 CARTON (0031-8716-12) / 118 mL in 1 BOTTLEMarketed from Sep 1, 2009

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): Childrens Robitussin Cough and Cold CF
Generic name (nonproprietary): dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Active ingredients: Dextromethorphan hydrobromide — 5 mg/5mLGuaifenesin — 50 mg/5mLPhenylephrine hydrochloride — 2.5 mg/5mL
Dosage form: Liquid
Route: Oral
Labeler: Haleon US Holdings LLCNDC labeler code 0031
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 001
Marketing start: Sep 1, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 0031-8716_13de3a9e-573f-846a-e063-6294a90a53c9SPL ID 13de3a9e-573f-846a-e063-6294a90a53c9SPL set ID fcd0a8e0-ac2a-039a-be3c-534195d6bcfdRxCUI 1370205UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Pharmacologic class: Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic 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

N400031871612 followed by a unit qualifier and the quantity

Package 00031-8716-12. 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 Mar 17, 2024.

Indications (excerpt from the label)

Uses helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0031-8716

What is NDC 0031-8716?: 0031-8716 is the product NDC for Childrens Robitussin Cough and Cold CF, Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients liquid, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Childrens Robitussin Cough and Cold CF (Dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride).
What is the active ingredient?: Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride.
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 Childrens Robitussin Cough and Cold CF?: 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 M 001

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

FDA NDC Directory listings under M 001
Product	Strength	Form · route	Labeler	Product NDC
Soothe Chewablecitric acid	Citric acid monohydrate 1.5 g/108.27g	Chewable gelOral	Carolina Cannabis Creations LLC	82876-840
ultra strength antacidantacid	Calcium carbonate 1000 mg/1	Tablet, ChewableOral	Target Corporation	11673-933
Rolaids Extra Strength Mintcalcium carbonate and magnesium hydroxide	Calcium carbonate 675 mg/1; Magnesium hydroxide 135 mg/1	Tablet, ChewableOral	Chattem, Inc.	41167-1001
Extra Strength Antacidcalcium carbonate	Calcium carbonate 750 mg/1	Tablet, ChewableOral	Grocery Outlet, Inc.	85828-903
Medique Alcalakcalcium carbonate	Calcium carbonate 420 mg/1	Tablet, ChewableOral	Unifirst First Aid Corporation	47682-201
Ultra Strength Antacidcalcium carbonate	Calcium carbonate 1000 mg/1	Tablet, ChewableOral	CVS	51316-171
Kirkland Ultra Stregth Antacid 171ABcalcium carbonate	Calcium carbonate 1000 mg/1	TabletOral	COSTCO WHOLESALE COMPANY	63981-171
Regular Strength Antacidcalcium carbonate	Calcium carbonate 500 mg/1	Tablet, ChewableOral	Harris Teeter, LLC	69256-138
Ultra Strength Antacidcalcium carbonate	Calcium carbonate 1000 mg/1	Tablet, ChewableOral	Grocery Outlet, Inc.	85828-905
Magnesium Oxide	Magnesium oxide 400 mg/1	TabletOral	A-S Medication Solutions	50090-7432
Ultra Strength Assorted Berry Antacidcalcium carbonate	Calcium carbonate 1000 mg/1	Tablet, ChewableOral	Harris Teeter, LLC	69256-171
Antacid- Calcium Carbonatecalcium carbonate	Calcium carbonate 1000 mg/1	Tablet, ChewableOral	Anhui Jiuhe Health Industry Co., Ltd	87745-001
Tums Chewy Bitescalcium carbonate	Calcium carbonate 1000 mg/1	Tablet, ChewableOral	Haleon US Holdings LLC	0135-0183
De La Cruz Desempachosodium bicarbonate	Sodium bicarbonate 525 mg/15mL	LiquidOral	DLC LABORATORIES, INC.	24286-1523
HEB Wild Berry Antacid Chewscalcium carbonate	Calcium carbonate 750 mg/1	Tablet, ChewableOral	HEB	37808-493
Unishield Antacidcalcium carbonate	Calcium carbonate 420 mg/1	Tablet, ChewableOral	Unishield	49314-1013
Calmicid AC Acid Reducerfamotidine	Famotidine 20 mg/1	Tablet, CoatedOral	Melaleuca, Inc.	54473-411
Exchange Select Antacid Tropical Fruitcalcium carbonate	Calcium carbonate 750 mg/1	Tablet, ChewableOral	ARMY AND AIR FORCE EXCHANGE SERVICE	55301-102
Leader Extra Strength Sugar Free Antacidantacid	Calcium carbonate 750 mg/1	Tablet, ChewableOral	Cardinal Health	70000-0460
Sodium Bicarbonate Antacidsodium bicarbonate	Sodium bicarbonate 650 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-669

Showing 20 of 40.