NDC codes

FDA NDC Directory
Product NDC (as listed)0031-8756Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00031-8756Add 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 NDC11-digit (billing)PackageCopy
0031-8756-1200031875612000318756121 BOTTLE in 1 CARTON (0031-8756-12) / 118 mL in 1 BOTTLEMarketed from Jun 25, 2018
0031-8756-1800031875618000318756181 BOTTLE in 1 CARTON (0031-8756-18) / 237 mL in 1 BOTTLEMarketed from Jun 25, 2018

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

Generic name (nonproprietary)
dextromethorphan hbr, guaifenesin
Active ingredients
Dextromethorphan hydrobromide — 20 mg/20mLGuaifenesin — 400 mg/20mL
Dosage form
Solution
Route
Oral
Labeler
Haleon US Holdings LLCNDC labeler code 0031
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Listing expires
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 0031-8756_178d098c-514f-d1fe-e063-6294a90af6caSPL ID 178d098c-514f-d1fe-e063-6294a90af6caSPL set ID eaa10aed-5b1e-48bf-bc05-7a5638851dafRxCUI 1020138UNII 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

N400031875612 followed by a unit qualifier and the quantity

Package 00031-8756-12. 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 .

Indications (excerpt from the label)

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0031-8756

What is NDC 0031-8756?
0031-8756 is the product NDC for Robitussin Honey Maximum Strength Cough and Chest Congestion DM, Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL solution, listed with the FDA by Haleon US Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Robitussin Honey Maximum Strength Cough and Chest Congestion DM (Dextromethorphan HBr, 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 Honey Maximum Strength Cough and Chest Congestion DM?
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 012

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

FDA NDC Directory listings under M 012
ProductStrengthForm · routeLabelerProduct NDC
MGC Health Cough Drops Honey HerbmentholMenthol 4.8 mg/1LozengeOralMedical Group Care LLC83173-133
Multi-Symptom Cold And Flu Relief Nighttimeacetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mgAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralRITE AID11822-1987
daytime severe cold and fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hclAcetaminophen 325 mg/15mL + 3 more ingredientsSolutionOralKroger Company30142-603
TopCare Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralTOPCO ASSOCIATES LLC36800-367
Daytime Cold And Fludextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochlorideDextromethorphan hydrobromide 10 mg/1 + 2 more ingredientsCapsule, Liquid filledOralKroger Company41226-693
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralFOODHOLD U.S.A., LLC41520-290
good sense tussin dmdextromethorphan hydrobromide, guaifenesinDextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mLSolutionOralA-S Medication Solutions50090-7257
SanatosmentholMenthol 5.4 mg/1LozengeOralPharmadel LLC55758-518
Cough DropsmentholMenthol 7.5 mg/1PastilleOralThe Kroger CO59450-716
Vicks NyQuil VapoCOOL COLD and FLUacetaminophen, doxylamine succinate, dextromethorphan hydrobromideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralNavajo Manufacturing Company Inc.67751-244
Childrens Allergy ReliefDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralAllegiant Health69168-471
Severe Cold Plus Flu Daytime Nighttimeacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate—KitCVS Pharmacy,Inc.69842-546
Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hclAcetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1TabletOralCardinal Health 110, LLC. DBA Leader70000-0161
Mucus Reliefguaifenesin 400 mgGuaifenesin 400 mg/1TabletOralPioneer Life Sciences, LLC72090-035
Mucinex Childrens Night Time Multi-Symptom Cold and Fluacetaminophen, dextromethorphan hbr, triprolidine hclTriprolidine hydrochloride 1.25 mg/10mL + 2 more ingredientsSolutionOralReckitt Benckiser LLC72854-063
Pharbinex-DMguaifenesin 400mg and dextromethorphan hbr 20mgGuaifenesin 400 mg/1; Dextromethorphan hydrobromide 20 mg/1TabletOralUlai Health LLC73057-381
MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ctacetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, phenylephrine hydrochloride—KitTopco Associates LLC76162-679
24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointmentEucalyptus oil 1.2 g/100g + 2 more ingredientsOintmentTopicalLil' Drug Store Products, Inc.29485-6536
Daytime and Nighttime Cherry Cold and Fludaytime - acetaminophen, dextromethorphan hbr, phenylephrine hcl nighttime - acetaminophen, dextromethorphan hbr, doxylamine succinate—KitOralBETTER LIVING BRANDS, LLC21130-967
Daytime Nighttimeacetaminophen, guaifenesin, acetaminophen, dextromethorphan hbr, triprolidine hcl—KitKROGER COMPANY41226-678

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