Home NDC 0485-0206-16 RYNEX PSE
Product NDC 0485-0206
Requested package NDC 0485-0206-16
11-digit product format 004850206
Labeler code 0485
Product ID 0485-0206_4c48242c-1746-1a49-e063-6294a90ac81d
Type HUMAN OTC DRUG
Nonproprietary name BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form LIQUID
Route ORAL
Labeler EDWARDS PHARMACEUTICALS, INC.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-03-07
Substance BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 1; 15 mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-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 PSE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMPHENIRAMINE MALEATE 1 mg/5mL PSEUDOEPHEDRINE HYDROCHLORIDE 15 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 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1098498 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 0485-0206-16 RYNEX PSE 473 mL in 1 BOTTLE, PLASTIC LIQUID 473 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BROMPHENIRAMINE MALEATE ACTIVE INGREDIENT IXA7C9ZN03 RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 BROMPHENIRAMINE ACTIVE MOIETY H57G17P2FN RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0485-0206 RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20241228_2f2d9b5a-f66b-4928-8d43-402ef9efcfdf.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 1 · 1 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 0485-0206-16 00485020616 473 mL in 1 BOTTLE, PLASTIC (0485-0206-16) 473 ml 2011-03-07 0000-00-00 No No Current