Rynex

Product NDC: 0485-0204
11-digit product format: 004850204
Labeler code: 0485
Product ID: 0485-0204_4746cbef-775f-90ce-e063-6394a90a0781
Type: HUMAN OTC DRUG
Nonproprietary name: Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: Edwards Pharmaceuticals, Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-03-14
Substance: PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 2.5; 1; 5 mg/5mL; 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

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: Rynex
Brand name suffix: DM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/5mL
BROMPHENIRAMINE MALEATE	1 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup
IXA7C9ZN03	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090463	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
7be2c282-24ba-4f19-9b14-872d3f5746a7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0485-0204-04	2023-08-10	Ed-RynexDM 0204
0485-0204-04	2023-08-10	Rynex DM Liquid
0485-0204-16	2023-08-10	Ed-RynexDM 0204
0485-0204-16	2023-08-10	Rynex DM Liquid
0485-0204-04	2023-07-28	Ed-RynexDM 0204
0485-0204-04	2023-07-28	Rynex DM Liquid
0485-0204-16	2023-07-28	Ed-RynexDM 0204
0485-0204-16	2023-07-28	Rynex DM Liquid
0485-0204-04	2020-04-08	Ed-RynexDM 0204
0485-0204-04	2020-04-08	Rynex DM Liquid
0485-0204-16	2020-04-08	Ed-RynexDM 0204
0485-0204-16	2020-04-08	Rynex DM Liquid
0485-0204-04	2020-01-31	Ed-RynexDM 0204
0485-0204-04	2020-01-31	Rynex DM Liquid
0485-0204-16	2020-01-31	Ed-RynexDM 0204
0485-0204-16	2020-01-31	Rynex DM Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0485-0204-04	RynexDM	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		15
0485-0204-16	RynexDM	473 mL in 1 BOTTLE	LIQUID	473		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0485-0204-04	ML - Milliliter	0485-0204	ab0b9870-27be-4e84-bb3b-868b147d1313	1	2013-05-02
0485-0204-16	ML - Milliliter	0485-0204	ce87ca29-0a73-44bd-be8f-096842cb3c8b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Brompheniramine Maleate	ACTIVE INGREDIENT	IXA7C9ZN03	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Brompheniramine	ACTIVE MOIETY	H57G17P2FN	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Saccharin Sodium Dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Sorbitol	INACTIVE INGREDIENT	506T60A25R	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5
Water	INACTIVE INGREDIENT	059QF0KO0R	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0485-0204	RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC]	13	Current NDC, Legacy NDC, 2 package rows	20241228_7be2c282-24ba-4f19-9b14-872d3f5746a7.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 90 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Cold and Flu Relief Daytime/Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e	2025-11-07	Warnings	Exact identifier application number: M012
Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	The Procter & Gamble Manufacturing Company	ff0bffee-9a36-8246-e053-6294a90a86c7	2025-11-06	Warnings	Exact identifier application number: M012
Xlear Nasal Decongestant	NASAL SPRAY	Xlear Inc.	1c1db71a-47d0-42ac-8cbe-95e76dca185f	2025-11-06	Warnings	Exact identifier application number: M012
Robitussin Honey Cough DM Day Night Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	1bbd0157-06e6-4a3b-bac9-91ac879ba089	2025-11-06	Warnings	Exact identifier application number: M012
ValuMeds Nasal Decongestant Phenylephrine HCl	PHENYLEPHRINE HYDROCHLORIDE	Cabinet Health P.B.C.	21676b0c-6be2-464c-ae91-92e5f0d0087d	2025-11-06	Warnings	Exact identifier application number: M012
COLD AND FLU SEVERE Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	04715af5-e861-496c-834a-233eb7312556	2025-11-06	Warnings	Exact identifier application number: M012
Severe Allergy Plus Sinus Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	1a1f41c4-5430-4cff-873e-6547dadc8779	2025-11-06	Warnings	Exact identifier application number: M012
Target Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	TARGET CORPORATION	05e944d5-3473-4d8c-8df4-2ffc7474e9fa	2025-11-05	Warnings	Exact identifier application number: M012
Target Cough plus Chest Congestion DM Max with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	TARGET CORPORATION	e36f179e-5aed-4fee-8b0a-767bf3590752	2025-11-05	Warnings	Exact identifier application number: M012
Target Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET CORPORATION	1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d2	2025-11-05	Warnings	Exact identifier application number: M012
Up and Up maximum Strength fast mucus relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	f007beaa-b108-46d5-8a98-853f011a8e2e	2025-11-05	Warnings	Exact identifier application number: M012
Target Childrens Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	TARGET CORPORATION	975e157a-8f8d-41ad-b55b-9f9100188ccd	2025-11-05	Warnings	Exact identifier application number: M012
Target Maximum Strength Cold Flu and Sore Throat Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND TRIPROLIDINE HCL	TARGET CORPORATION	6e94fdab-27ea-4c0f-a91c-735ce697304b	2025-11-05	Warnings	Exact identifier application number: M012
Target Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Target Corporation	76299495-7259-4bbe-8393-7eabfe22715a	2025-11-05	Warnings	Exact identifier application number: M012
TARGET CHILDRENS DT AND NT COLD and COUGH	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	TARGET CORPORATION	05ac2a40-5eee-4013-b55b-6e370a28b21c	2025-11-05	Warnings	Exact identifier application number: M012
TARGET CHILDRENs COLD and COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	TARGET CORPORATION	eb912834-1b14-484d-90f7-a8deb52c0d4e	2025-11-05	Warnings	Exact identifier application number: M012
UP and UP Daytime Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	a2d99bc8-7295-4922-acff-0cb02c91273c	2025-11-05	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	AMERISOURCE BERGEN	c1843f1a-ae5b-0fdf-e053-2995a90aae38	2025-11-05	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	4754363d-e163-42e0-a65d-1c4bac24f6c9	2025-11-05	Warnings	Exact identifier application number: M012
Day Time Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	Safeway, Inc.	76d62892-615d-4744-95aa-3be1207a0e57	2025-11-05	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
IXA7C9ZN03	BROMPHENIRAMINE MALEATE	980-71-2	BROMPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1090463	brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	7be2c282-24ba-4f19-9b14-872d3f5746a7	15
1090463	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	7be2c282-24ba-4f19-9b14-872d3f5746a7	15
1090463	brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	7be2c282-24ba-4f19-9b14-872d3f5746a7	15
1090463	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	7be2c282-24ba-4f19-9b14-872d3f5746a7	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0485-0204-04	00485020404	118 mL in 1 BOTTLE, PLASTIC (0485-0204-04)	118 ml	2011-03-14	0000-00-00	No	No	Current
0485-0204-16	00485020416	473 mL in 1 BOTTLE (0485-0204-16)	473 ml	2011-03-14	0000-00-00	No	No	Current