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: 2026-12-31
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 47 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	51e34704-5e6b-4e80-836c-ddbc24a451b2	2026-03-06	Warnings	Exact identifier application number: M012
Medi-First Plus Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	20f58b0b-c123-477f-a62c-fa5423e23f93	2026-03-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	Sportpharm LLC	7f4e8d37-8c6b-4849-b86c-4335a0bcac1c	2026-03-06	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cold and Flu Kit	DAYTIME AND NIGHTTIME COLD AND FLU KIT	Allegiant Health	0533db78-7809-46ea-9998-deb5f6f1d0d9	2026-03-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	Better Living Brands, LLC	0153294d-7f52-4d92-8db8-daeca3e29a3b	2026-03-06	Warnings	Exact identifier application number: M012
Mucus DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Meijer Distribution, Inc.	87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e	2026-03-06	Warnings	Exact identifier application number: M012
RYNEX PE	BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	EDWARDS PHARMACEUTICALS, INC.	77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef	2026-03-05	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	042f9449-4af0-4b15-bb3e-236afeb1e11f	2026-03-05	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN	Amerisource Bergen	087a3a0b-8d3f-45ed-8807-0af47b446cac	2026-03-05	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG	NUVICARE LLC	6c4bc7d1-09d9-4311-8457-a1d47ab02a5a	2026-03-05	Warnings	Exact identifier application number: M012
Allergy Relief childrens	DIPHENHYDRAMINE HCL	WALMART INC.	dceb99a9-4aa3-4acc-b632-9a4ba8c87919	2026-03-04	Warnings	Exact identifier application number: M012
AMAZON Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AMAZON.COM SERVICES LLC	26101105-a6cf-4b51-a639-9d078542fea3	2026-03-04	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	3a976e90-c6af-4414-984e-9987158c9e98	2026-03-04	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Best Choice (Valu Merchandisers Company)	714e93ec-0aa9-4be2-9311-399e82f148e0	2026-03-04	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	d1131759-dd2e-4c06-bb73-92dd975f5511	2026-03-04	Warnings	Exact identifier application number: M012
AMAZON Maximim Strength Adult Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	AMAZON.COM SERVICES LLC	6bbe8cc9-7a60-4476-b5cf-b13c5bebff26	2026-03-04	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	5a1dfaf3-370d-4ac7-a72d-a48863a35741	2026-03-04	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	c5cb09d4-c049-461c-8898-2c5bb6a8a138	2026-03-04	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	WinCo Foods, LLC	3d96d6d0-8c04-43bb-aed0-4cd00cdf3456	2026-03-04	Warnings	Exact identifier application number: M012
DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	e2994c0f-add8-4f75-a6d2-24cd2af271e4	2026-03-03	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