Broncofin

Manufacturer: Menper Distributors, Inc. | RNV, LLC
Effective date: 2025-07-22
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:08:23

Label at a glance#

ProductBroncofin

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Label structure12 sections

Indications and uses

Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with the common cold or inhaled irritants

Dosage and administration

Adults and children 12 years of age and over: take 2 teaspoons (10 mL) every 4 hours. Do not exceed 6 doses in 24 hours. Children under 12 years of age: consult a doctor.

Contacts and useful links#

PhoneLabel contact1-800-560-5223

Label contents#

Full prescribing information#

Active Ingredients (in each teaspoonful, (5mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 10 mg

Phenylephrine HCI 5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with the common cold or inhaled irritants

Do not exceed recommended dosage.

WARNINGS SECTION

If nervousness, dizziness, or sleepiness occur, discontinue use and consult a doctor. A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Do not use

OTC - DO NOT USE SECTION

this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to enlargement of the prostate gland, unless directed by a doctor

If you are pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: take 2 teaspoons (10 mL) every 4 hours. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: consult a doctor.

Other information

OTHER SAFETY INFORMATION

Store this product between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cherry flavor, FD&C red #40, FD&C yellow #6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, sucrose, water

Questions?

OTC - QUESTIONS SECTION

call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

broncofin

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1435918	dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution	dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1435918	dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution	PSN	7
1435918	dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution	SCD	7
1435918	dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral Solution	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-026-34	2023-07-28	C162847	48780-1	9d75b9d0-3e53-f424-e053-dadaa90a57ce	Broncofin
53145-026-34	2022-02-18	C162847	48780-1	9d75b9d0-3e53-f424-e053-dadaa90a57ce	Broncofin
53145-026-34	2022-01-28	C162847	48780-1	9d75b9d0-3e53-f424-e053-dadaa90a57ce	Broncofin
53145-026-34	2020-02-07	C162847	48780-1	9d75b9d0-3e53-f424-e053-dadaa90a57ce	Broncofin
53145-026-34	2020-01-31	C162847	48780-1	9d75b9d0-3e53-f424-e053-dadaa90a57ce	Broncofin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53145-026-34	Broncofin	1 in 1 CARTON	LIQUID	1		7
53145-026-34	Broncofin	118 mL in 1 BOTTLE	LIQUID	118		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Broncofin
DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
GLYCERIN
MENTHOL
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SUCROSE
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53145-026	53145-026-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SUCROSE	C151H8M554	IACT
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MENTHOL	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii+route 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii+route 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii+route 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii+route 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii+route 18 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Broncofin	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Menper Distributors, Inc.	fdf67382-1692-485b-92f1-2cbb8be4fb70	2025-07-22	Warnings	Exact identifier ndc (package): 53145-026-34 ndc (product): 53145-026 ndc11 (package): 53145002634 spl id: 3a89891b-eb56-2ff3-e063-6294a90a742b spl set id: fdf67382-1692-485b-92f1-2cbb8be4fb70

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.