RYNEX PE

Product NDC: 0485-0202
11-digit product format: 004850202
Labeler code: 0485
Product ID: 0485-0202_4c481ad3-2e51-1c12-e063-6294a90a4b6b
Type: HUMAN OTC DRUG
Nonproprietary name: BROMPHENIRAMINE MALEATE and Phenylephrine HCL
Dosage form: LIQUID
Route: ORAL
Labeler: EDWARDS PHARMACEUTICALS, INC.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-03-07
Substance: BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 1; 2.5 mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: RYNEX PE
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IXA7C9ZN03	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
1053258	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
77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef	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
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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
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
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0485-0202-16	RYNEX PE	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0485-0202-16	ML - Milliliter	0485-0202	7df84534-7fde-4615-bd19-b4d1caf0f083	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	IXA7C9ZN03	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0485-0202	RYNEX PE (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20241228_77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef.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 195 · 3,895 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Cold Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	077fac1a-0ec5-40d9-8861-a281b48f650a	2026-09-08	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IXA7C9ZN03	BROMPHENIRAMINE MALEATE	980-71-2	BROMPHENIRAMINE MALEATE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1053258	brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef	9
1053258	brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef	9
1053258	brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Elixir	SY	77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef	9
1053258	brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef	9
1053258	brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0485-0202-16	00485020216	473 mL in 1 BOTTLE, PLASTIC (0485-0202-16)	473 ml	2011-03-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RYNEX PE	EDWARDS PHARMACEUTICALS, INC. \| Llorens Pharmaceutical	2026-03-05	HUMAN OTC DRUG LABEL	9