Home NDC 0485-0204 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 73 of 178 · 3,550 matching rows.
DailyMed RxNorm Mappings# 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