What is NDC 49580-0415?

49580-0415 is the product NDC for Severe Cold and Flu Relief Daytime, Acetaminophen 325 mg/15mL + 3 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?

Severe Cold and Flu Relief Daytime (Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride).

What is the active ingredient?

Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, 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 Severe Cold and Flu Relief Daytime?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Severe Cold and Flu Relief Daytime NDC 49580-0415

NDC codes

FDA NDC Directory

Product NDC (as listed)49580-0415Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49580-0415Add 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
49580-0415-8	4958004150849580041508	237 mL in 1 BOTTLE, PLASTIC (49580-0415-8)Marketed from Mar 26, 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): Severe Cold and Flu Relief DaytimeSuffix: Daytime
Generic name (nonproprietary): acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Active ingredients: Acetaminophen — 325 mg/15mLDextromethorphan hydrobromide — 10 mg/15mLGuaifenesin — 200 mg/15mLPhenylephrine hydrochloride — 5 mg/15mL
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: Mar 26, 2021
Listing expires: Dec 31, 2027
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 49580-0415_c005f7ca-3f3b-4dbb-80fe-8cde626f13d5SPL ID c005f7ca-3f3b-4dbb-80fe-8cde626f13d5SPL set ID 5872fed8-862b-44a2-a06e-51ebf8618271RxCUI 1369842UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJUPC 0349580415089
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

N449580041508 followed by a unit qualifier and the quantity

Package 49580-0415-08. 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 25, 2024.

Indications (excerpt from the label)

Uses temporarily relieves common cold and flu symptoms: nasal congestion sinus congestion and pressure minor aches and pains headache fever sore throat reduces swelling of nasal passages cough due to minor throat and bronchial irritation temporarily restores freer breathing through the nose promotes nasal and or sinus drainage helps loosen phlegn (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49580-0415

What is NDC 49580-0415?: 49580-0415 is the product NDC for Severe Cold and Flu Relief Daytime, Acetaminophen 325 mg/15mL + 3 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?: Severe Cold and Flu Relief Daytime (Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride).
What is the active ingredient?: Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, 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 Severe Cold and Flu Relief Daytime?: 2 other product NDCs are listed under this name. See all Severe Cold and Flu Relief Daytime 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 Severe Cold and Flu Relief Daytime NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Severe Cold and Flu Relief Daytimeacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride	Acetaminophen 325 mg/15mL + 3 more ingredients	LiquidOral	Walgreens	0363-4150	00363-4150-08
Severe Cold and Flu Relief Daytimeacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride	Acetaminophen 325 mg/15mL + 3 more ingredients	LiquidOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-515	55910-0515-08

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
Cough Reliefdextromethorphan hydrobromide	Dextromethorphan hydrobromide 15 mg/1	Capsule, Liquid filledOral	Advanced Rx LLC	80513-311
TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr	—	Kit	TARGET CORPORATION	82442-559
Geri-Dryl allergy reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	VerityRx	83939-0683
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci	—	Kit	TARGET Corporation	11673-420
Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxide	Petrolatum 49 g/100g; Zinc oxide 15 g/100g	CreamTopical	Welmedix LLC	24330-410
topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	Topco Associates LLC	36800-143
Allergy Childrensdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	LiquidOral	H E B	37808-012
Mucus Relief Cough Childrensdextromethorphan hbr, guaifensin	Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL	LiquidOral	H E B	37808-594
Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesin	Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1	TabletOral	Strategic Sourcing Services LLC	49348-728
Dual Action Honey Lemon Cough Suppressant Oral Anestheticmenthol	Menthol 8.3 mg/1	LozengeOral	Ricola Ag	54305-323
Discount drug mart Extra Moisturizingoxymetazoline hydrochloride	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	DISCOUNT DRUG MART	53943-720
Mucus Reliefguaifenesin	Guaifenesin 400 mg/1	TabletOral	Geri-Care Pharmaceuticals, Corp	57896-714
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hcl	Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL	LiquidOral	Haleon US Holdings LLC	0031-0101
Throat Comfort Orange Mint Cinnamon Dropsmenthol	Menthol 3.6 mg/1	LozengeOral	Ricola USA Inc.	63667-342
Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coated	Guaifenesin 200 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Lil' Drug Store products, Inc.	66715-5632
COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Capsule, Liquid filledOral	Walgreens	0363-9016
Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hcl	Acetaminophen 650 mg/20mL + 2 more ingredients	LiquidOral	Walgreens	0363-9130
Pyrilamine Maleate and Dextromethorphan Hydrobromide	Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL	LiquidOral	Westminster Pharmaceuticals, LLC	69367-398
Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hcl	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	AptaPharma Inc.	76281-604
Cough Dropsmenthol	Menthol 5.8 mg/1	PastilleOral	Topco Associates LLC	76162-016

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