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
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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