Broncofin

Product NDC: 53145-026
11-digit product format: 531450026
Labeler code: 53145
Product ID: 53145-026_3a89891b-eb56-2ff3-e063-6294a90a742b
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
Dosage form: LIQUID
Route: ORAL
Labeler: Menper Distributors, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-02-21
Substance: DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10; 5 mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	53145-026		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53145-026	53145-026-34	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Broncofin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1435918	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fdf67382-1692-485b-92f1-2cbb8be4fb70	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-07-28	Broncofin
2022-02-18	Broncofin
2022-01-28	Broncofin
2020-02-07	Broncofin
2020-01-31	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	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	BRONCOFIN LIQUID [MENPER DISTRIBUTORS, INC.]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	BRONCOFIN LIQUID [MENPER DISTRIBUTORS, INC.]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	BRONCOFIN LIQUID [MENPER DISTRIBUTORS, INC.]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	BRONCOFIN LIQUID [MENPER DISTRIBUTORS, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BRONCOFIN LIQUID [MENPER DISTRIBUTORS, INC.]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	BRONCOFIN LIQUID [MENPER DISTRIBUTORS, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BRONCOFIN LIQUID [MENPER DISTRIBUTORS, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BRONCOFIN LIQUID [MENPER DISTRIBUTORS, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BRONCOFIN LIQUID [MENPER DISTRIBUTORS, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	BRONCOFIN LIQUID [MENPER DISTRIBUTORS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BRONCOFIN LIQUID [MENPER DISTRIBUTORS, INC.]	2

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 75 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Mucus Relief Cough Cherry Liquid	DEXTROMETHORPHAN HBR, GUAIFENSIN	Topco Associates	3170748e-b09f-4c07-9927-df43771166c5	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	e70d0784-53bc-4910-aade-3c9ad6e36441	2025-12-16	Warnings	Exact identifier application number: M012
Pain and Sinus	ACETAMINOPHEN AND PHENYLEPHRINE	JHK Inc dba American Safety & First Aid	88f86f5a-cc2b-4c75-b7a4-f2021922280b	2025-12-16	Warnings	Exact identifier application number: M012
Severe Congestion and Cough, Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	b75af815-9bd4-4a7a-bc68-f42f4af50699	2025-12-16	Warnings	Exact identifier application number: M012
Cough Relief Nighttime	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fe5fd29e-7f81-4633-8c3b-010d68abe701	2025-12-16	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	e0a62fa1-9f8a-4770-b28b-1f4f02a762e0	2025-12-16	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	8c4b59b8-dfab-4f4a-9966-f07b026a758a	2025-12-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	QUALITY CHOICE (Chain Drug Marketing Association)	df866cf6-0526-4e61-ac9b-245b57dd5df6	2025-12-16	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	c89200b6-4adb-452e-b931-07f631dad641	2025-12-16	Warnings	Exact identifier application number: M012
ONESSIP ADULT DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	MEDWISE LIFESCIENCES INC.	45fa9159-d74c-063a-e063-6294a90a3ed0	2025-12-15	Warnings	Exact identifier application number: M012
SudoGest Nasal Decongestant	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	5229f4b2-a194-46f8-a0bc-4510fbe52075	2025-12-15	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f2b2467f-2d9b-4742-b90a-95975c3b694f	2025-12-13	Warnings	Exact identifier application number: M012
Menthol Cough Drop	MENTHOL	HEB	39178eb7-ada9-30bf-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
SF Menthol Cough Drop	MENTHOL	HEB	3a443179-b7a6-3242-e054-00144ff8d46c	2025-12-13	Warnings	Exact identifier application number: M012
Cherry cough drop	MENTHOL	HEB	39bd0ca1-348f-0ce1-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
Strawberry Cough Drops	MENTHOL	HEB	766236e2-3302-2232-e053-2991aa0af503	2025-12-13	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drop	MENTHOL	HEB	3a30a427-6ab4-24ae-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
Mixed Berry Sore Throat and Cough Lozenges	BENZOCAINE	HEB	3063ea93-6bc2-1d18-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
HEB Menthol Cough Drops	MENTHOL	HEB	c197855d-15b4-38fc-e053-2a95a90a2dc7	2025-12-13	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1435918	dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution	PSN	fdf67382-1692-485b-92f1-2cbb8be4fb70	7
1435918	dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution	SCD	fdf67382-1692-485b-92f1-2cbb8be4fb70	7
1435918	dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral Solution	SY	fdf67382-1692-485b-92f1-2cbb8be4fb70	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53145-026-34	53145002634	1 BOTTLE in 1 CARTON (53145-026-34) / 118 mL in 1 BOTTLE	1 bottle	2012-02-21	0000-00-00	No	No	Current