What is NDC 51316-546?

51316-546 is the product NDC for Sinus PE Head Congestion and Flu Severe, Acetaminophen 325 mg/1 + 3 more ingredients tablet, film coated, listed with the FDA by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sinus PE Head Congestion and Flu Severe (Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl).

What is the active ingredient?

Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride.

CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sinus PE Head Congestion and Flu Severe?

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.

Sinus PE Head Congestion and Flu Severe NDC 51316-546

NDC codes

FDA NDC Directory

Product NDC (as listed)51316-546Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51316-0546Add 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
51316-546-08	5131605460851316054608	2 BLISTER PACK in 1 CARTON (51316-546-08) / 12 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 25, 2021

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Sinus PE Head Congestion and Flu Severe
Generic name (nonproprietary): acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Active ingredients: Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Guaifenesin — 100 mg/1Phenylephrine hydrochloride — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNDC labeler code 51316
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Sep 25, 2021
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 51316-546_febc58fe-43ce-4761-8b98-d9c12886a638SPL ID febc58fe-43ce-4761-8b98-d9c12886a638SPL set ID 76fd1f8e-2670-421c-a9e6-c8adefb7962eRxCUI 1098435UNII 362O9ITL9D, 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

N451316054608 followed by a unit qualifier and the quantity

Package 51316-0546-08. 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 Dec 23, 2025.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to the common cold: headache nasal congestion cough minor aches and pains sore throat sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51316-546

What is NDC 51316-546?: 51316-546 is the product NDC for Sinus PE Head Congestion and Flu Severe, Acetaminophen 325 mg/1 + 3 more ingredients tablet, film coated, listed with the FDA by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sinus PE Head Congestion and Flu Severe (Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl).
What is the active ingredient?: Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride.
Who is the labeler?: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sinus PE Head Congestion and Flu Severe?: 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
Allergy Reliefdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	WALGREENS	0363-0100
CVS Health No Dripnasal mist	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	CVS PHARMACY,INC.	69842-815
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONacetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, CoatedOral	The Procter & Gamble Manufacturing Company	69423-986
Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	SolutionOral	Lidl US LLC	71141-180
basic care tussin dm maxdextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL	SolutionOral	Amazon.com Services LLC	72288-293
Menthol Cough Drops Honey Vanilla Flavormenthol	Menthol 2.5 mg/1	LozengeOral	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	83698-013
equate daytime nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesen, phenylephrine hydrochloride	—	Kit	Sixarp, LLC	59368-459
Nasal Decongestant Maximum Strengthpseudoephedrine hcl	Pseudoephedrine hydrochloride 30 mg/1	Tablet, Film coatedOral	Better Living Brands, LLC	21130-112
Medicated Chest Rubcamphor, menthol, eucalyptus oil	Camphor (Synthetic) 4.8 g/100g + 2 more ingredients	CreamTopical	Jell Pharmaceuticals Pvt Ltd.	30400-701
equaline nighttime cold and flu reliefacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	SolutionOral	United Natural Foods, Inc. dba UNFI	41163-459
NiteTime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	LiquidOral	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	49035-044
Childrens Dye Free Allergydiphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	LiquidOral	P & L Development, LLC	49580-0293
Discount Drug Mart Original Nasaloxymetazoline hydrochloride	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	DISCOUNT DRUG MART	53943-715
Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl	Acetaminophen 650 mg/20mL + 3 more ingredients	SolutionOral	Family Dollar Services Inc	55319-705
DG Health Cold and Flu Severeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride	Acetaminophen 325 mg/15mL + 3 more ingredients	SolutionOral	Dolgencorp Inc	55910-928
Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride	Acetaminophen 650 mg/20mL + 3 more ingredients	LiquidOral	Haleon US Holdings LLC	0031-8751
Afrin No Drip Pump Mist Bundle Packoxymetazoline hydrochloride	—	KitNasal	Bayer HealthCare LLC.	11523-0147
Cold Medicine XL3acetaminophen chlorpheniramine maleate phenylepherine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	TabletOral	Selder, S.A. de C.V.	63654-605
Nasal Spray, 1oz, 24/7 Life by 7-Elevenoxymetazoline hcl nasal solution 0.05%	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	Lil' Drug Store Products, Inc.	66715-5526
Vicks childrens Cough Congestionphenylephrine hcl, dextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 10 mg/15mL + 2 more ingredients	LiquidOral	The Procter & Gamble Manufacturing Company	69423-982

Showing 20 of 40.