What is NDC 49580-0502?

49580-0502 is the product NDC for Nighttime Severe Cold and Cough, Acetaminophen 650 mg/30mL + 2 more ingredients liquid, listed with the FDA by P & L Development, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Nighttime Severe Cold and Cough (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl).

What is the active ingredient?

Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride.

P & L Development, LLC, NDC labeler code 49580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nighttime Severe Cold and Cough?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nighttime Severe Cold and Cough NDC 49580-0502

NDC codes

FDA NDC Directory

Product NDC (as listed)49580-0502Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49580-0502Add 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
49580-0502-8	4958005020849580050208	245 mL in 1 BOTTLE, PLASTIC (49580-0502-8)Marketed from Apr 30, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Nighttime Severe Cold and Cough
Generic name (nonproprietary): acetaminophen, diphenhydramine hcl, phenylephrine hcl
Active ingredients: Acetaminophen — 650 mg/30mLDiphenhydramine hydrochloride — 25 mg/30mLPhenylephrine hydrochloride — 10 mg/30mL
Dosage form: Liquid
Route: Oral
Labeler: P & L Development, LLCNDC labeler code 49580
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Apr 30, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 49580-0502_48c92b40-7cf7-492b-96d4-d4209532fcdcSPL ID 48c92b40-7cf7-492b-96d4-d4209532fcdcSPL set ID 8d27b94d-23a1-4e6c-a064-79e2580f7e2eRxCUI 1298348UNII 362O9ITL9D, TC2D6JAD40, 04JA59TNSJ
Pharmacologic class: Histamine-1 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

N449580050208 followed by a unit qualifier and the quantity

Package 49580-0502-08. 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 Apr 15, 2024.

Indications (excerpt from the label)

Uses temporarily relieves there symptoms due to a cold minor aches and pains headache sore throat runny nose sneezing itchy, watery eyes due to hay fever nasal and sinus congestion itching of the nose or throat cough due to minor throat and bronchial irritation temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49580-0502

What is NDC 49580-0502?: 49580-0502 is the product NDC for Nighttime Severe Cold and Cough, Acetaminophen 650 mg/30mL + 2 more ingredients liquid, listed with the FDA by P & L Development, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nighttime Severe Cold and Cough (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl).
What is the active ingredient?: Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride.
Who is the labeler?: P & L Development, LLC, NDC labeler code 49580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nighttime Severe Cold and Cough?: 2 other product NDCs are listed under this name. See all Nighttime Severe Cold and Cough NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nighttime Severe Cold and Cough NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nighttime Severe Cold and Coughacetaminophen, diphenhydramine, phenylephrine	Acetaminophen 650 mg/1 + 2 more ingredients	Powder, For solutionOral	KROGER COMPANY	41226-541	41226-0541-06
Nighttime Severe Cold and Coughacetaminophen, diphenhydramine, phenylephrine	Acetaminophen 650 mg/1 + 2 more ingredients	Powder, For solutionOral	RARITAN PHARMACEUTICALS INC	68163-541	68163-0541-06

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

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