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	00031871612	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
Acid Gone Antacidaluminum hydroxide and magnesium carbonate	Aluminum hydroxide 95 mg/15mL; Magnesium carbonate 358 mg/15mL	LiquidOral	Major Pharmaceuticals	0904-7727
Acid Gone Antacid Extra Strengthaluminum hydroxide and magnesium carbonate	Aluminum hydroxide 160 mg/1; Magnesium carbonate 105 mg/1	Tablet, ChewableOral	Major Pharmaceuticals	0904-5365
ADRIAN BICARBONATO SODIUM BICARBONATE USP-4 oz, 8 oz and 16 ozsodium bicarbonate	Sodium bicarbonate 315 mg/g	PowderOral	Evi Labs	84178-106
Advanced Antacid Mintaluminum hydroxide, magnesium hydroxide, dimethicone	Aluminum hydroxide 400 mg/10mL + 2 more ingredients	SuspensionOral	GOODSENSE	50804-639
Advanced Regular Strength Antacidaluminum hydroxide, magnesium hydroxide, simethicone	Aluminum hydroxide 200 mg/5mL + 2 more ingredients	SuspensionOral	WALGREEN COMPANY	0363-1639
Alka-Seltzer Cool Action Extra Strength ReliefChews Mintcalcium carbonate	Calcium carbonate 750 mg/1	Tablet, ChewableOral	Bayer HealthCare LLC.	0280-0058
Alka-Seltzer Cool Action Heartburn Relief Mintcalcium carbonate	Calcium carbonate 750 mg/1	Gum, ChewingOral	Bayer HealthCare LLC.	0280-0001
Alka-Seltzer Extra Strengthanhydrous citric acid, sodium bicarbonate, and aspirin	Anhydrous citric acid 1000 mg/1 + 2 more ingredients	Granule, EffervescentOral	Bayer HealthCare LLC.	0280-0211
Alka-Seltzer Extra Strength Heartburn ReliefChewscalcium carbonate	Calcium carbonate 750 mg/1	Tablet, ChewableOral	Bayer HealthCare LLC.	0280-0042
Alka-Seltzer Gold	Citric acid monohydrate 1000 mg/1 + 2 more ingredients	Tablet, EffervescentOral	Bayer HealthCare LLC.	0280-4100
Alka-Seltzer Heartburnanhydrous citric acid, sodium bicarbonate (heat-treated)	Citric acid monohydrate 1000 mg/1; Sodium bicarbonate 1940 mg/1	Tablet, EffervescentOral	Bayer HealthCare LLC.	0280-0047
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical Punchcalcium carbonate and simethicone	Dimethicone 80 mg/1; Calcium carbonate 750 mg/1	Tablet, ChewableOral	Bayer HealthCare LLC.	0280-0225
Alka-Seltzer Heartburn Relief Extra Strengthanhydrous citric acid, sodium bicarbonate (heat-treated)	Sodium bicarbonate 1976 mg/1; Citric acid monohydrate 1000 mg/1	Tablet, EffervescentOral	Bayer Healthcare LLC	0280-0079
Alka-Seltzer Heartburn Relief Lemon Limeanhydrous citric acid, sodium bicarbonate (heat-treated)	Sodium bicarbonate 1650 mg/1; Citric acid monohydrate 1000 mg/1	Tablet, EffervescentOral	Bayer Healthcare LLC	0280-0083
Alka-Seltzer Heartburn Relief Peppermintcalcium carbonate	Calcium carbonate 750 mg/1	Gum, ChewingOral	Bayer HealthCare LLC.	0280-0002
Alka-Seltzer Heartburn ReliefChewscalcium carbonate	Calcium carbonate 750 mg/1	Tablet, ChewableOral	Bayer HealthCare LLC.	0280-0221
Alka-Seltzer Heartburn ReliefChews Strawberry and Orangecalcium carbonate	Calcium carbonate 750 mg/1	Tablet, ChewableOral	Bayer HealthCare LLC.	0280-0224
Alka-Seltzer Kids Tummy ReliefChewscalcium carbonate and dimethicone	Calcium carbonate 750 mg/1; Dimethicone 80 mg/1	Tablet, ChewableOral	Bayer HealthCare LLC.	0280-0051
Alka-Seltzer Ultra Strength Heartburn ReliefChewscalcium carbonate	Calcium carbonate 1000 mg/1	Tablet, ChewableOral	Bayer HealthCare LLC.	0280-0245
Alka-Seltzer Ultra Strength Heartburn ReliefChews Strawberry and Orangecalcium carbonate	Calcium carbonate 1000 mg/1	Tablet, ChewableOral	Bayer HealthCare LLC.	0280-0059

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