Home NDC 0485-0208 ED BRON GP
Product NDC 0485-0208
11-digit product format 004850208
Labeler code 0485
Product ID 0485-0208_423e6598-ff90-d9d4-e063-6294a90a1fba
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN and PHENYLEPHRINE
Dosage form LIQUID
Route ORAL
Labeler EDWARDS PHARMACEUTICALS, INC.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2012-06-01
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 100; 5 mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base ED BRON GP
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ 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 1358627 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0485-0208-16 ED BRON GP 473 mL in 1 BOTTLE, PLASTIC LIQUID 473 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 PHENYLEPHRINE ACTIVE INGREDIENT 1WS297W6MV ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0485-0208 ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20241228_b1fca5aa-d877-45e0-b074-dcbc6af94ee3.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 0485-0208-16 00485020816 473 mL in 1 BOTTLE, PLASTIC (0485-0208-16) 473 ml 2012-06-01 0000-00-00 No No Current