What is NDC 0031-9301?

0031-9301 is the product NDC for Robitussin Direct Sore Throat Pain, Acetaminophen 500 mg/1 tablet, coated, 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?

Robitussin Direct Sore Throat Pain (Acetaminophen).

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 Direct Sore Throat Pain?

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.

Robitussin Direct Sore Throat Pain NDC 0031-9301

NDC codes

FDA NDC Directory

Product NDC (as listed)0031-9301Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00031-9301Add 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
0031-9301-01	00031930101	18 TABLET, COATED in 1 BOTTLE (0031-9301-01)Marketed from Jul 15, 2022

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 Direct Sore Throat Pain
Generic name (nonproprietary): acetaminophen
Active ingredients: Acetaminophen — 500 mg/1
Dosage form: Tablet, Coated
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: Jul 15, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 0031-9301_159c0477-cdc8-fbc7-e063-6294a90a3448SPL ID 159c0477-cdc8-fbc7-e063-6294a90a3448SPL set ID 1b512078-24c3-4b80-8f2c-d6824d367f25RxCUI 198440UNII 362O9ITL9D

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

N400031930101 followed by a unit qualifier and the quantity

Package 00031-9301-01. 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 8, 2024.

Indications (excerpt from the label)

Uses temporarily relieves minor aches and pains due to: sore throat headache backache toothache premenstrual and menstrual cramps the common cold minor pain of arthritis muscular aches temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0031-9301

What is NDC 0031-9301?: 0031-9301 is the product NDC for Robitussin Direct Sore Throat Pain, Acetaminophen 500 mg/1 tablet, coated, 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?: Robitussin Direct Sore Throat Pain (Acetaminophen).
What is the active ingredient?: Acetaminophen.
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 Direct Sore Throat Pain?: 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
Product	Strength	Form · route	Labeler	Product NDC
Cold and Flu HBPacetaminophen, chlorpheniramine maleate	Acetaminophen 325 mg/1; Chlorpheniramine maleate 2 mg/1	Tablet, Film coatedOral	WALMART INC.	79903-120
Equate Daytime Nighttime Vapor Ice Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	—	Kit	WALMART INC.	79903-417
Night Time Cold and Flu ReadyInCaseacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	LiquidOral	P & L Development, LLC	49580-0343
Sinus Severeacetaminophen, guaifenesin, phenylephrine hcl	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, Film coatedOral	L.N.K. International, Inc.	50844-572
SUDAFED PE Head Congestion Plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, Film coatedOral	Kenvue Brands LLC	50580-450
Nighttime severe cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl	Dextromethorphan hydrobromide 20 mg/30mL + 3 more ingredients	LiquidOral	TARGET CORPORATION	11673-828
Freegells Cough Drops Menthol Cherry 30ctmenthol	Levomenthol 5.8 mg/1	LozengeOral	RL Albert & Son Inc.	83002-040
Sanatosmenthol	Menthol 5.4 mg/1	LozengeOral	Pharmadel LLC	55758-518
Pressure and Pain Plus Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, CoatedOral	VALU MERCHANDISERS COMPANY	63941-173
Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl	Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients	SyrupOral	Dextrum Laboratories, Inc	65852-020
Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hbr and doxylamine succinate	Acetaminophen 325 mg/1 + 2 more ingredients	CapsuleOral	Chain Drug Consortium, LLC	68016-878
Head Congestion plus Flu Severe PEacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, CoatedOral	HARRIS TEETER	72036-274
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttimeacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl	Acetaminophen 1000 mg/30mL + 3 more ingredients	SyrupOral	Haleon US Holdings LLC	0067-0114
Childrens Cough and Congestion, Childrens Cold and Cough Day, Nightdextromethorphan hbr, doxylamine succinate, guaifenesin	—	Kit	WALMART INC.	79903-414
Meijer Adult MS Severe Multi-Symptom Cough Cold Fluaacetaminophen, dextromethorphan hbr and guaifenesi	Acetaminophen 650 mg/20mL + 2 more ingredients	LiquidOral	MEIJER DISTRIBUTION INC	79481-6308
Menthol Cough Dropsmenthol	Menthol 5.8 mg/1	PastilleOral	Target Corporation Inc.	82442-001
adult dm max cough and chest congestiondextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL	SolutionOral	Meijer Distribution Inc	41250-261
Bio-Rytusschlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride	Chlorpheniramine maleate 2 mg/5mL + 2 more ingredients	LiquidOral	Advanced Generic Corporation	45737-250
Allergy Reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/1	TabletOral	AMERISOURCE BERGEN	46122-829
Cold Relief Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl	—	Kit	L.N.K. International, Inc.	50844-529

Showing 20 of 40.

Robitussin Direct Sore Throat Pain (Acetaminophen) NDC 0031-9301