What is NDC 49580-0416?

49580-0416 is the product NDC for Severe cold and flu Nighttime, Acetaminophen 650 mg/30mL + 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 Nighttime (Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI).

What is the active ingredient?

Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, 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 Nighttime?

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 Nighttime NDC 49580-0416

NDC codes

FDA NDC Directory

Product NDC (as listed)49580-0416Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49580-0416Add 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
49580-0416-8	4958004160849580041608	237 mL in 1 BOTTLE, PLASTIC (49580-0416-8)Marketed from Aug 31, 2015

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 NighttimeSuffix: Nighttime
Generic name (nonproprietary): acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci
Active ingredients: Acetaminophen — 650 mg/30mLDextromethorphan hydrobromide — 20 mg/30mLDoxylamine succinate — 12.5 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: Aug 31, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 49580-0416_46f4b7c3-c197-4717-8036-499652b0d716SPL ID 46f4b7c3-c197-4717-8036-499652b0d716SPL set ID 7c92bdcf-db1f-4299-982f-6a3da9cba6e6RxCUI 1431245UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJUPC 0349580416086
Pharmacologic class: Antihistamine; 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

N449580041608 followed by a unit qualifier and the quantity

Package 49580-0416-08. 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/flu symptoms: nasal congestion sinus congestion and pressure cough due to minor throat and bronchial irritation minor aches and pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage runny nose and sneezing cough to help you sleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49580-0416

What is NDC 49580-0416?: 49580-0416 is the product NDC for Severe cold and flu Nighttime, Acetaminophen 650 mg/30mL + 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 Nighttime (Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI).
What is the active ingredient?: Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, 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 Nighttime?: 2 other product NDCs are listed under this name. See all Severe cold and flu Nighttime 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 Nighttime NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Severe cold and flu Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci	Acetaminophen 650 mg/30mL + 3 more ingredients	LiquidOral	P & L Development, LLC	49580-4160	49580-4160-08
Severe cold and flu Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci	Acetaminophen 650 mg/30mL + 3 more ingredients	LiquidOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-716	55910-0716-08

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
MGC Health Cough Drops Honey Herbmenthol	Menthol 4.8 mg/1	LozengeOral	Medical Group Care LLC	83173-133
Multi-Symptom Cold And Flu Relief Nighttimeacetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mg	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	RITE AID	11822-1987
daytime severe cold and fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl	Acetaminophen 325 mg/15mL + 3 more ingredients	SolutionOral	Kroger Company	30142-603
TopCare Allergy Reliefdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	TOPCO ASSOCIATES LLC	36800-367
Daytime Cold And Fludextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride	Dextromethorphan hydrobromide 10 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	Kroger Company	41226-693
Allergy Reliefdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	FOODHOLD U.S.A., LLC	41520-290
good sense tussin dmdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mL	SolutionOral	A-S Medication Solutions	50090-7257
Sanatosmenthol	Menthol 5.4 mg/1	LozengeOral	Pharmadel LLC	55758-518
Cough Dropsmenthol	Menthol 7.5 mg/1	PastilleOral	The Kroger CO	59450-716
Vicks NyQuil VapoCOOL COLD and FLUacetaminophen, doxylamine succinate, dextromethorphan hydrobromide	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, CoatedOral	Navajo Manufacturing Company Inc.	67751-244
Childrens Allergy Relief	Diphenhydramine hydrochloride 12.5 mg/5mL	LiquidOral	Allegiant Health	69168-471
Severe Cold Plus Flu Daytime Nighttimeacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate	—	Kit	CVS Pharmacy,Inc.	69842-546
Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hcl	Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1	TabletOral	Cardinal Health 110, LLC. DBA Leader	70000-0161
Mucus Reliefguaifenesin 400 mg	Guaifenesin 400 mg/1	TabletOral	Pioneer Life Sciences, LLC	72090-035
Mucinex Childrens Night Time Multi-Symptom Cold and Fluacetaminophen, dextromethorphan hbr, triprolidine hcl	Triprolidine hydrochloride 1.25 mg/10mL + 2 more ingredients	SolutionOral	Reckitt Benckiser LLC	72854-063
Pharbinex-DMguaifenesin 400mg and dextromethorphan hbr 20mg	Guaifenesin 400 mg/1; Dextromethorphan hydrobromide 20 mg/1	TabletOral	Ulai Health LLC	73057-381
MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ctacetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, phenylephrine hydrochloride	—	Kit	Topco Associates LLC	76162-679
24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointment	Eucalyptus oil 1.2 g/100g + 2 more ingredients	OintmentTopical	Lil' Drug Store Products, Inc.	29485-6536
Daytime and Nighttime Cherry Cold and Fludaytime - acetaminophen, dextromethorphan hbr, phenylephrine hcl nighttime - acetaminophen, dextromethorphan hbr, doxylamine succinate	—	KitOral	BETTER LIVING BRANDS, LLC	21130-967
Daytime Nighttimeacetaminophen, guaifenesin, acetaminophen, dextromethorphan hbr, triprolidine hcl	—	Kit	KROGER COMPANY	41226-678

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