Home NDC 0485-0155-16 ED A-HIST
Product NDC 0485-0155
Requested package NDC 0485-0155-16
11-digit product format 004850155
Labeler code 0485
Product ID 0485-0155_423e4fde-affe-b593-e063-6394a90aa884
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine/Phenylephrine
Dosage form LIQUID
Route ORAL
Labeler Edwards Pharmaceuticals, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-01-11
Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 4; 10 mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 A-HIST
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 4 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z 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 1086463 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 0485-0155-16 ED A-HIST 473 mL in 1 BOTTLE, PLASTIC LIQUID 473 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Chlorpheniramine Maleate ACTIVE INGREDIENT V1Q0O9OJ9Z ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 Chlorpheniramine ACTIVE MOIETY 3U6IO1965U ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 Phenylephrine ACTIVE MOIETY 1WS297W6MV ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 Alcohol INACTIVE INGREDIENT 3K9958V90M ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 Glycerin INACTIVE INGREDIENT PDC6A3C0OX ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 Sorbitol INACTIVE INGREDIENT 506T60A25R ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0485-0155 ED A-HIST (CHLORPHENIRAMINE/PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20241228_bf5c4a23-9581-4b84-a75b-e17e1d768970.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 0485-0155-16 00485015516 473 mL in 1 BOTTLE, PLASTIC (0485-0155-16) 473 ml 2011-01-11 0000-00-00 No No Current