Conex

Product NDC: 54859-702
11-digit product format: 548590702
Labeler code: 54859
Product ID: 54859-702_472e27dc-944c-73bf-e063-6294a90a21b9
Type: HUMAN OTC DRUG
Nonproprietary name: Dexbrompheniramine Maleate, Pseudoephedrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-11-01
Substance: DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 2; 60 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54859-702		I	Inactivated by FDA		2026-09-14
excluded package	package	54859-702	54859-702-60	I	Inactivated by FDA		2026-09-14

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54859-702-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54859-702-60	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54859-702-60	2020-12-23	C162847	48780-1	9d75b9d0-1486-f424-e053-dadaa90a57ce	Conex Tab Allergy 702
54859-702-60	2020-01-31	C162847	48780-1	9d75b9d0-1486-f424-e053-dadaa90a57ce	Conex Tab Allergy 702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-702-60	Conex	60 in 1 BOTTLE	TABLET	60		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-702-60	EA - Each	54859-702	31e821dd-b951-472b-b0d5-0b8bdce2e125	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXBROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	BPA9UT29BS	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
DEXBROMPHENIRAMINE	ACTIVE MOIETY	75T64B71RP	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
SODIUM STARCH GLYCOLATE TYPE B POTATO	INACTIVE INGREDIENT	27NA468985	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-702	CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	5	Current NDC, Legacy NDC, 1 package rows	20241222_82f9f52c-797e-4842-9c9a-40213181d99a.zip

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 191 · 3,814 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLTALIN-DM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	FORTUNE PHARMACAL COMPANY LIMITED	33e1bec0-323b-40b7-809a-cb65a71ad0ce	2026-09-17	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Geiss, Destin & Dunn Inc.	1ea07a01-8779-48c2-a287-b7be866cce7b	2026-09-10	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy Relief	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	d64fe757-9948-4727-b5dd-1f8e4e4763e2	2026-09-10	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	Kroger Company	fd41e4a4-330f-4409-8ba3-0b3bb6f45bca	2026-09-10	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	Raritan Pharmaceuticals Inc	303d7651-9c8f-4a14-9f2c-7181fa0f003e	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Fruit Punch	GUAIFENESIN	Raritan Pharmaceuticals Inc	a19d7e1c-c04e-41c6-8af6-ecde96299216	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	2cb3e17f-3858-4773-a53f-0860ae6ff1b9	2026-09-09	Warnings	Exact identifier application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	3856c1e4-814f-85c4-e063-6394a90ab8a8	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Long Acting Cough	DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	875b40bd-7955-4048-abbf-7f43d9ea3ac5	2026-09-09	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	4b8ae971-ab57-4937-a878-72d905d7b849	2026-09-09	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	82ba9a73-60ef-49fd-960f-5ca2bb79555e	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN	The Kroger Co.	49829083-5c0a-4620-bfb3-7103642368db	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HCL	RARITAN PHARMACEUTICALS	7a3bb739-ff50-4d29-b270-d6b084906493	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Children daytime Cough and Chest Congestion	DEXTROMETHORPHAN HBR AND GUAIFENESIN	RARITAN PHARMACEUTICALS	25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	8a166067-b492-4742-b74c-28fac87c8d70	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice maximum strength Severe Cough plus sore throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	a096cb76-0d1c-4ca8-854a-5199da0bc8f7	2026-09-09	Warnings	Exact identifier application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	efb69cc1-a745-6efc-e053-2a95a90abdc9	2026-09-08	Warnings	Exact identifier application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	efb5f0b9-9825-ab23-e053-2995a90a26ab	2026-09-08	Warnings	Exact identifier application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	The Procter & Gamble Manufacturing Company	f4328b44-cdfa-41aa-e053-2995a90a2728	2026-09-08	Warnings	Exact identifier application number: M012
Vicks childrens Cough Congestion	PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	The Procter & Gamble Manufacturing Company	e2356457-9791-3710-e053-2995a90ad140	2026-09-08	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BPA9UT29BS	DEXBROMPHENIRAMINE MALEATE	2391-03-9	DEXBROMPHENIRAMINE MALEATE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1363513	dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG Oral Tablet	PSN	82f9f52c-797e-4842-9c9a-40213181d99a	8
1363513	dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet	SCD	82f9f52c-797e-4842-9c9a-40213181d99a	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-702-60	54859070260	60 TABLET in 1 BOTTLE (54859-702-60)	60 tablet	2007-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Conex Tab Allergy 702	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2025-12-30	HUMAN OTC DRUG LABEL	8