What is NDC 0135-0578?

0135-0578 is the product NDC for FLONASE Headache and Allergy Relief, Acetaminophen 325 mg/1 + 2 more ingredients tablet, listed with the FDA by Haleon US Holdings LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

FLONASE Headache and Allergy Relief (Acetaminophen, chlorpheniramine maleate, phenylephrine hcl).

What is the active ingredient?

Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride.

Haleon US Holdings LLC, NDC labeler code 0135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for FLONASE Headache and Allergy Relief?

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.

FLONASE Headache and Allergy Relief NDC 0135-0578

NDC codes

FDA NDC Directory

Product NDC (as listed)0135-0578Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00135-0578Add 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
0135-0578-01	0013505780100135057801	1 BLISTER PACK in 1 CARTON (0135-0578-01) / 12 TABLET in 1 BLISTER PACKMarketed from Mar 10, 2022
0135-0578-02	0013505780200135057802	4 BLISTER PACK in 1 CARTON (0135-0578-02) / 48 TABLET in 1 BLISTER PACKMarketed from Mar 10, 2022
0135-0578-03	0013505780300135057803	8 BLISTER PACK in 1 CARTON (0135-0578-03) / 96 TABLET in 1 BLISTER PACKMarketed from Mar 10, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): FLONASE Headache and Allergy ReliefSuffix: Headache and Allergy Relief
Generic name (nonproprietary): acetaminophen, chlorpheniramine maleate, phenylephrine hcl
Active ingredients: Acetaminophen — 325 mg/1Chlorpheniramine maleate — 2 mg/1Phenylephrine hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Haleon US Holdings LLCNDC labeler code 0135
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Mar 10, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0135-0578_1599c55d-8de5-cc14-e063-6394a90aba82SPL ID 1599c55d-8de5-cc14-e063-6394a90aba82SPL set ID 282c103c-3888-4a35-a5b1-d492ed6892c1RxCUI 1046781UNII 362O9ITL9D, V1Q0O9OJ9Z, 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

N400135057801 followed by a unit qualifier and the quantity

Package 00135-0578-01. 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 Apr 8, 2024.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: sinus congestion and pressure runny nose and sneezing minor aches and pains nasal congestion headache temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus openings and passages

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0135-0578

What is NDC 0135-0578?: 0135-0578 is the product NDC for FLONASE Headache and Allergy Relief, Acetaminophen 325 mg/1 + 2 more ingredients tablet, listed with the FDA by Haleon US Holdings LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: FLONASE Headache and Allergy Relief (Acetaminophen, chlorpheniramine maleate, phenylephrine hcl).
What is the active ingredient?: Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride.
Who is the labeler?: Haleon US Holdings LLC, NDC labeler code 0135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for FLONASE Headache and Allergy Relief?: 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
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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