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 84 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	f1a73da7-0dbb-49bd-857e-7dd6bc11b63c	2025-12-02	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	ac74be47-30f0-418b-bd07-502feaa9723f	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens High Blood Pressure Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN	WALGREENS CO.	bc83b55e-c3d8-460f-8ef9-ff7b2e4f7272	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen High Blood Pressure Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREENS CO.	f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Nighttime Kids Honey Cold Cough Congestion	DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO	c0f317cd-723d-47f2-b600-aaeae6399482	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen Maximum Strength Severe Congestion and cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALGREENS CO.	b4abcb6d-f3e1-4d63-98cf-ff556ec423b6	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Daytime Childrens	COUGH AND CHEST CONGESTION	WALGREENS CO.	dd99675f-3860-42ef-999c-d9a3746a38c0	2025-12-01	Warnings	Exact identifier application number: M012
Adult Cough plus Chest Congestion DM with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	WALGREEN COMPANY	5f5af13a-c2a3-4bbe-880e-9c57b36e9234	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREEN COMPANY	b2e08f4d-9753-4767-a8eb-3740dd1034cc	2025-12-01	Warnings	Exact identifier application number: M012
WALGREENS Cold Cough and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	1e903034-942e-4c6e-9f96-eb097c266580	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens DAY and NIGHT PACK	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	WALGREEN CO	cb87e57b-ff06-4973-9751-137c7021e272	2025-12-01	Warnings	Exact identifier application number: M012
WALGREEN Multi Symptom Flu Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	WALGREENS CO.	b7b1d604-921d-4ae7-93de-dcf690d421b4	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Meijer Distribution Inc	235b2866-bbda-7148-e063-6394a90a898f	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Whole Foods Market, INC.	32352109-31dc-8e6f-e063-6294a90a2f92	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	323347c3-d51a-4976-e063-6294a90a952e	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	WALGREEN COMPANY	2969ba8f-c477-222a-e063-6394a90af703	2025-12-01	Warnings	Exact identifier application number: M012
CareAll Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS	New World Imports, Inc	4cd2f751-e072-4f4e-b059-ed1dfcc60c6b	2025-12-01	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY, INC	bbb1b395-48d9-4859-ad52-6650961089d9	2025-12-01	Warnings	Exact identifier application number: M012
Severe Sinus Pain and Congestion	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	fbc541ac-9465-4296-bb1e-811b9d811f40	2025-11-26	Warnings	Exact identifier application number: M012
Daytime Severe and Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Grocery Outlet, Inc.	447951e6-459d-0a52-e063-6294a90a6226	2025-11-26	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