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 63 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zicam Extreme Congestion Relief	OXYMETAZOLINE HYDROCHLORIDE	Church & Dwight Co., Inc.	ccada339-656c-a461-e053-2a95a90a3479	2025-12-31	Warnings	Exact identifier application number: M012
ED A-HIST DM	DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	e0e2b117-62bc-4132-9f7c-fe2a912052b1	2025-12-31	Warnings	Exact identifier application number: M012
Bio-Z-Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Advanced Generic Corporation	05e70eab-1467-4b09-991e-ef03f222e021	2025-12-31	Warnings	Exact identifier application number: M012
Altipres-B	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Alternative Pharmacal Corporation	fd00c41d-0580-4177-afaa-60bb12ca5a09	2025-12-31	Warnings	Exact identifier application number: M012
Ninjacof-D	CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	Centurion Labs, LLC	5188aa20-41f1-4998-81e1-f4de055874bc	2025-12-31	Warnings	Exact identifier application number: M012
Llorens Care Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	4743e562-1217-50ab-e063-6394a90af88d	2025-12-31	Warnings	Exact identifier application number: M012
Llorens Care Tussin	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	474459c1-bfd7-dec7-e063-6394a90ac18d	2025-12-31	Warnings	Exact identifier application number: M012
Geri Care Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN	GERI-CARE PHARMACEUTICAL CORP	4744669c-7f33-e35f-e063-6394a90a79b7	2025-12-31	Warnings	Exact identifier application number: M012
Geri-Tussin	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	65545ca3-4e93-4b59-9e17-4742e086e8e7	2025-12-31	Warnings	Exact identifier application number: M012
GeriCare Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	GERI-CARE PHARMACEUTICALS, CORP	47451cd8-7aab-90e2-e063-6394a90ad1b7	2025-12-31	Warnings	Exact identifier application number: M012
Curewell Tussin	GUAIFENESIN	RMT HEALTH LLC	47455587-5074-e70d-e063-6294a90a78bb	2025-12-31	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Bestco Inc.	77e25027-3c96-21fa-e053-2991aa0a1f31	2025-12-31	Warnings	Exact identifier application number: M012
Puregen Labs Allergy Relief	DIPHENHYDRAMINE HCL	Advanced Rx LLC	4745d4f9-bbdf-a4a6-e063-6294a90a15b2	2025-12-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2a46ea9b-29e9-5197-e063-6394a90abc73	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Bestco Inc.	77e50410-306d-b2fb-e053-2a91aa0af3c5	2025-12-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	e086a6d2-f664-454e-9524-f656bfbf45df	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Bestco Inc.	77f45efb-8ee0-1186-e053-2991aa0a9884	2025-12-31	Warnings	Exact identifier application number: M012
Conex Pediatric	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	2a46af43-ef36-e14e-e063-6394a90a8285	2025-12-31	Warnings	Exact identifier application number: M012
Conex	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	2a343656-ac6d-8b20-e063-6294a90ab319	2025-12-31	Warnings	Exact identifier application number: M012
Dologesic NF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Llorens Pharmaceutical International Division	974fc0d5-7a99-46fb-af38-b91240f728fa	2025-12-31	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