NDC codes

FDA NDC Directory
Product NDC (as listed)0031-9310Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00031-9310Add 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
0031-9310-100003193101010 TABLET, CHEWABLE in 1 BOTTLE (0031-9310-10)Marketed from Jun 19, 2024
0031-9310-200003193102020 TABLET, CHEWABLE in 1 BOTTLE (0031-9310-20)Marketed from Jun 19, 2024

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 hydrobromide
Active ingredients
Dextromethorphan hydrobromide — 15 mg/1
Dosage form
Tablet, Chewable
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
Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 0031-9310_4471f0f1-079c-219b-e063-6294a90ae0bbSPL ID 4471f0f1-079c-219b-e063-6294a90ae0bbSPL set ID f22248b7-7abd-4df7-a986-dae357ebe8f1RxCUI 2173731UNII 9D2RTI9KYH
Pharmacologic class
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

N400031931010 followed by a unit qualifier and the quantity

Package 00031-9310-10. 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)

Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0031-9310

What is NDC 0031-9310?
0031-9310 is the product NDC for ROBITUSSIN LONG-ACTING COUGH Soft CHEWS, Dextromethorphan hydrobromide 15 mg/1 tablet, chewable, 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 LONG-ACTING COUGH Soft CHEWS (Dextromethorphan hydrobromide).
What is the active ingredient?
Dextromethorphan hydrobromide.
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 LONG-ACTING COUGH Soft CHEWS?
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
Childrens Benadryl ALLERGYdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLSolutionOralKenvue Brands LLC50580-534
Cold Maxacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralDISCOUNT DRUG MART53943-138
Kroger DayTime Cold and Flu SOFTGELacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralThe Kroger Co.59450-046
CVS Overnight Cold and Flu Clear and Coolacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochlorideAcetaminophen 650 mg/20mL + 3 more ingredientsSolutionOralCVS PHARMACY, INC69842-966
Sinus Head Congestionacetaminophen, phenylephrine hydrochlorideAcetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1Capsule, Liquid filledOralVIVUNT PHARMA LLC82706-025
Leader Cough Drops Vanilla HoneymentholMenthol, Unspecified form 2.5 mg/1LozengeOralXiamen Kang Zhongyuan Biotechnology Co., Ltd.83698-692
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHEB37808-590
Oxymetazoline HydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalBi-Mart37835-996
Vaporxcamphor (synthetic), eucalyptus oil, and mentholCamphor (Synthetic) .048 g/g + 2 more ingredientsOintmentTopicalAKRON PHARMA INC71399-4589
Global Care 4Oz Vapor Rubmenthol, camphor, eucalyptus oilMenthol 1 g/100g + 2 more ingredientsOintmentTopicalGLOBAL IMPORT SALES LLC72146-008
Adult Allergy Reliefcalmco allergy reliefDiphenhydramine hydrochloride 25 mg/1Bar, ChewableOralCalmCo73282-2520
Severe cold and flu Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hciAcetaminophen 650 mg/30mL + 3 more ingredientsLiquidOralP & L Development, LLC49580-4160
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-packacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride—KitKenvue Brands LLC50580-526
Daytime and Nighttimeacetaminophen, guaifenesin, dextromethorphan hbr, doxylamine succinate—KitOralCVS HEALTH CORP51316-961
Alka-Seltzer Plus Severe Cold Powerfast Fizz Nightaspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrateAspirin 500 mg/1 + 3 more ingredientsTablet, EffervescentOralBayer HealthCare LLC.0280-0021
Sinus Pressure plus Pain PEacetaminophen and phenylephrine hydrochlorideAcetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1Tablet, CoatedOralVALU MERCHANDISERS COMPANY63941-220
Daytime Cold And Flu Multi-Symptom Reliefacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsCapsuleOralChain Drug Consortium, LLC68016-877
Sugar Free Cough Drops Black CherrymentholMenthol 5.8 mg/1PastilleOralCardinal Health 110, Inc.70000-0643
Multi-Symptom Cold childrensdextromethorphan hbr, guaifenesin, phenylephrine hclDextromethorphan hydrobromide 5 mg/5mL + 2 more ingredientsSolutionOralWALMART INC.79903-176
AXIV DayTime - Liquidacetaminophen, dextromethorphan hydrobromideAcetaminophen 650 mg/30mL; Dextromethorphan hydrobromide 20 mg/30mLLiquidOralVIVUNT PHARMA LLC82706-022

Showing 20 of 40.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in