What is NDC 53041-616?

53041-616 is the product NDC for Tussnex FM Cold and Sinus, Acetaminophen 650 mg/20mL + 2 more ingredients liquid, listed with the FDA by Guardian Drug Company. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Tussnex FM Cold and Sinus (Acteaminophen, Guaifenesin, Phenylephrine HCl).

What is the active ingredient?

Acetaminophen, Guaifenesin, Phenylephrine hydrochloride.

Guardian Drug Company, NDC labeler code 53041. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tussnex FM Cold and Sinus?

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.

Tussnex FM Cold and Sinus NDC 53041-616

NDC codes

FDA NDC Directory

Product NDC (as listed)53041-616Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53041-0616Add 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
53041-616-58	53041061658	177 mL in 1 BOTTLE (53041-616-58)Marketed from Dec 1, 2012

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): Tussnex FM Cold and Sinus
Generic name (nonproprietary): acteaminophen, guaifenesin, phenylephrine hcl
Active ingredients: Acetaminophen — 650 mg/20mLGuaifenesin — 400 mg/20mLPhenylephrine hydrochloride — 10 mg/20mL
Dosage form: Liquid
Route: Oral
Labeler: Guardian Drug CompanyNDC labeler code 53041
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Dec 1, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers: Product ID 53041-616_3e372558-1578-4c25-962a-43af6b54de75SPL ID 3e372558-1578-4c25-962a-43af6b54de75SPL set ID 04c6bb6a-d2f8-4322-afba-e240e8090176RxCUI 1116568UNII 362O9ITL9D, 495W7451VQ, 04JA59TNSJ
Pharmacologic class: Expectorant; 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

N453041061658 followed by a unit qualifier and the quantity

Package 53041-0616-58. 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 19, 2024.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53041-616

What is NDC 53041-616?: 53041-616 is the product NDC for Tussnex FM Cold and Sinus, Acetaminophen 650 mg/20mL + 2 more ingredients liquid, listed with the FDA by Guardian Drug Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tussnex FM Cold and Sinus (Acteaminophen, Guaifenesin, Phenylephrine HCl).
What is the active ingredient?: Acetaminophen, Guaifenesin, Phenylephrine hydrochloride.
Who is the labeler?: Guardian Drug Company, NDC labeler code 53041. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tussnex FM Cold and Sinus?: 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

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