What is NDC 65131-097?

65131-097 is the product NDC for Broncochem Cold And Flu Tea, Acetaminophen 500 mg/13g; Chlorpheniramine maleate 4 mg/13g granule, for solution, listed with the FDA by LABORATORIO MAGNACHEM INTERNATIONAL SRL. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Broncochem Cold And Flu Tea (Acetaminophen-phenylephrine hydrochloride-chlorpheniramine maleate).

What is the active ingredient?

Acetaminophen, Chlorpheniramine maleate.

LABORATORIO MAGNACHEM INTERNATIONAL SRL, NDC labeler code 65131. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Broncochem Cold And Flu Tea?

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.

Broncochem Cold And Flu Tea NDC 65131-097

NDC codes

FDA NDC Directory

Product NDC (as listed)65131-097Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65131-0097Add 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
65131-097-12	6513100971265131009712	25 PACKAGE in 1 BOX (65131-097-12) / 13 g in 1 PACKAGE (65131-097-52)Marketed from Sep 28, 2017
65131-097-53	6513100975365131009753	6 PACKAGE in 1 BOX (65131-097-53) / 13 g in 1 PACKAGE (65131-097-52)Marketed from Sep 28, 2017

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): Broncochem Cold And Flu TeaSuffix: COLD AND FLU TEA
Generic name (nonproprietary): acetaminophen-phenylephrine hydrochloride-chlorpheniramine maleate
Active ingredients: Acetaminophen — 500 mg/13gChlorpheniramine maleate — 4 mg/13g
Dosage form: Granule, For solution
Route: Oral
Labeler: LABORATORIO MAGNACHEM INTERNATIONAL SRLNDC labeler code 65131
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M
Marketing start: Sep 1, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 65131-097_54539b4d-eb99-4198-8486-bfac15605c04SPL ID 54539b4d-eb99-4198-8486-bfac15605c04SPL set ID b7d3f54e-59ef-4b85-a88d-b053058dc1f6UNII 362O9ITL9D, V1Q0O9OJ9ZUPC 0805418097532
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

N465131009712 followed by a unit qualifier and the quantity

Package 65131-0097-12. 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 Dec 12, 2024.

Indications (excerpt from the label)

Indications and Usage Temporarily relieves these symptoms due to a cold: Minor aches and pains. Minor sore throat pain. Headache. Nasal and sinus congestion. Runny nose. Sneezing Itchy nose or throat. Itchy, watery eyes due to hay fever. Cough due to minor throat and bronchial irritation. Temporarily reduces fever. Dosage and Administration Do not use more than directed. Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor. Children under 4 years of age-Do not ue. Children from 4 to 12 years of age-Do not use unless directed by a doctor. Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold wate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65131-097

What is NDC 65131-097?: 65131-097 is the product NDC for Broncochem Cold And Flu Tea, Acetaminophen 500 mg/13g; Chlorpheniramine maleate 4 mg/13g granule, for solution, listed with the FDA by LABORATORIO MAGNACHEM INTERNATIONAL SRL. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Broncochem Cold And Flu Tea (Acetaminophen-phenylephrine hydrochloride-chlorpheniramine maleate).
What is the active ingredient?: Acetaminophen, Chlorpheniramine maleate.
Who is the labeler?: LABORATORIO MAGNACHEM INTERNATIONAL SRL, NDC labeler code 65131. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Broncochem Cold And Flu Tea?: 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

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M
Product	Strength	Form · route	Labeler	Product NDC
CETAFEN COUGH and COLDacetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, ,	Guaifenesin 100 mg/1 + 3 more ingredients	Tablet, Film coatedOral	HART Health	50332-0141
Therastatcherry cough drops	Menthol 5.8 mg/1	LozengeOral	HART Health	50332-0137
Aspirin	Aspirin 325 mg/1	TabletOral	HART Health	50332-0139
MG FoamSan 70ethyl alcohol	Alcohol .7 L/L	LiquidTopical	Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.	50241-223
Cetafen Extraacetaminophen	Acetaminophen 500 mg/1	TabletOral	HART Health	50332-0149
IT Cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral Richhomosalate, octisalate and octocrylene	Homosalate 100 mg/mL + 2 more ingredients	CreamTopical	LOreal USA Products Inc	49967-904
Cetafenacetaminophen	Acetaminophen 325 mg/1	TabletOral	HART Health	50332-0148
MG DermaClean	Benzalkonium chloride .13 g/100g	LiquidTopical	Morgan Gallacher Inc.	50241-014
Antibacterial Liquid Handbenzalkonium chloride	Benzalkonium chloride 13 kg/100kg	LiquidTopical	Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.	50241-317
Relief-PEacetaminophen, phenylephrine, chlorpheniramine	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, CoatedOral	HART Health	50332-0153
Hand Sanitizer Solution 101benzalkonium chloride	Benzalkonium chloride 13 kg/100kg	LiquidTopical	Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.	50241-224
Histaprindiphenhydramine	Diphenhydramine hydrochloride 25 mg/1	TabletOral	NorMed	50332-0150
MG DermaSan	Benzalkonium chloride .1 g/100g	LiquidTopical	Morgan Gallacher Inc.	50241-259
Nutraloxcalcium carbonate	Calcium carbonate 420 mg/1	Tablet, ChewableOral	HART Health	50332-0151
MG DermaWashbenzalkonium chloride	Benzalkonium chloride 13 kg/100kg	LiquidTopical	Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.	50241-302
Ibuprofen	Ibuprofen 200 mg/1	TabletOral	HART Health	50332-0152
MG DermaGel 62 LVethyl alcohol	Alcohol .62 L/L	LiquidTopical	Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.	50241-464
Eye Cleaneye wash	Water 98.3 mL/100mL	LiquidOphthalmic	HART Health	50332-0201
MG DermaGel 62ethyl alcohol	Alcohol .62 L/L	LiquidTopical	Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.	50241-326
Cetirzacetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	HART Health	50332-0154

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