What is NDC 50580-535?

50580-535 is the product NDC for Childrens Benadryl DYE-FREE ALLERGY, Diphenhydramine hydrochloride 12.5 mg/5mL solution, listed with the FDA by Kenvue Brands LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Childrens Benadryl DYE-FREE ALLERGY (Diphenhydramine hydrochloride).

Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Childrens Benadryl DYE-FREE ALLERGY?

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.

Childrens Benadryl DYE-FREE ALLERGY NDC 50580-535

NDC codes

FDA NDC Directory

Product NDC (as listed)50580-535Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50580-0535Add 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
50580-535-01	50580053501	1 BOTTLE in 1 CARTON (50580-535-01) / 118 mL in 1 BOTTLEMarketed from Dec 1, 2015
50580-535-02	50580053502	2 CARTON in 1 PACKAGE (50580-535-02) / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLEMarketed from Nov 18, 2024
50580-535-08	50580053508	1 BOTTLE in 1 CARTON (50580-535-08) / 236 mL in 1 BOTTLEMarketed from Jun 16, 2022

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): Childrens Benadryl DYE-FREE ALLERGY
Generic name (nonproprietary): diphenhydramine hydrochloride
Active ingredients: Diphenhydramine hydrochloride — 12.5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Kenvue Brands LLCNDC labeler code 50580
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Jul 1, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 50580-535_27d44a57-0879-63ea-e063-6394a90ac4cfSPL ID 27d44a57-0879-63ea-e063-6394a90ac4cfSPL set ID 10d478ff-ddc6-45da-87ff-cfe1b2b07a8eRxCUI 1049906, 1049908UNII TC2D6JAD40
Pharmacologic class: Histamine-1 Receptor Antagonist

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

N450580053501 followed by a unit qualifier and the quantity

Package 50580-0535-01. 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 Nov 27, 2024.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50580-535

What is NDC 50580-535?: 50580-535 is the product NDC for Childrens Benadryl DYE-FREE ALLERGY, Diphenhydramine hydrochloride 12.5 mg/5mL solution, listed with the FDA by Kenvue Brands LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Childrens Benadryl DYE-FREE ALLERGY (Diphenhydramine hydrochloride).
What is the active ingredient?: Diphenhydramine hydrochloride.
Who is the labeler?: Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Childrens Benadryl DYE-FREE ALLERGY?: 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

Showing 20 of 40.

Childrens Benadryl DYE-FREE ALLERGY (Diphenhydramine hydrochloride) NDC 50580-535