Home NDC 0485-0080 RYMED
Product NDC 0485-0080
11-digit product format 004850080
Labeler code 0485
Product ID 0485-0080_1f841aa1-98fd-59f8-e063-6394a90a2d75
Type HUMAN OTC DRUG
Nonproprietary name DEXCHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler EDWARDS PHARMACEUTICALS, INC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-11-15
Substance DEXCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 2; 10 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 RYMED
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXCHLORPHENIRAMINE MALEATE 2 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B10YD955QW 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 2184108 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 0485-0080-01 RYMED 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXCHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT B10YD955QW RYMED (DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ RYMED (DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 DEXCHLORPHENIRAMINE ACTIVE MOIETY 3Q9Q0B929N RYMED (DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV RYMED (DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RYMED (DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RYMED (DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B RYMED (DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0485-0080 RYMED (DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250110_c1d6e914-74cc-4cdf-9587-7eaaa4a386e5.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 71 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CAREALL Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc f3b177ef-55d5-4525-bf33-99205c414a5b 2025-12-22 Warnings Exact identifier application number: M012 CAREALL Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc af2f8389-d696-4060-8abd-6eda04e73009 2025-12-22 Warnings Exact identifier application number: M012 BASIC CARE DAYTIME NIGHTTIME SEVERE COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Amazon.com Services LLC 82e68c65-9898-4106-a2f8-e39d124c703e 2025-12-22 Warnings Exact identifier application number: M012 Nighttime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Harris Teeter, LLC 89fd57d2-fe49-41cb-b02e-9643e526cf47 2025-12-22 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Walgreens 464f6645-ca33-1722-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Walgreen Co. 47f38e79-c730-21b9-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Walgreen Co. 47522852-005a-2a66-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon Cough Drop MENTHOL Walgreens Co, 47653657-80b5-482f-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon Cough Drop MENTHOL Walgreen Co. 47f89d33-6e0a-4bb4-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Strawberry Cough Drop MENTHOL 2.7 MG Walgreen Co. 4766afa8-fdaf-05e5-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 SF Menthol Cough Drop MENTHOL Walgreen Co. 477b9fc3-c3c5-647e-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 SF Honey Lemon Cough Drop MENTHOL Walgreen Co. 477cedee-6bd3-2a34-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE Walgreens Co. 47e0f809-0b30-2b23-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Sugar Free Honey Lemon Cough Drops MENTHOL Walgreen 835e276a-493e-1038-e053-2a91aa0a7ea2 2025-12-21 Warnings Exact identifier application number: M012 Walgreens Mixed Berry Benz-Dex Lozenges BENZOCAINE Walgreen e108731f-6b77-225a-e053-2a95a90ac25c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Walmart Stores Inc. 318e7acb-0ebb-4518-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Walmart Stores Inc. 316968e1-7715-4caa-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon cough drops MENTHOL Walmart Stores Inc. 317bbd33-6087-3af1-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Good Sense Nasal Decongestant PSEUDOEPHEDRINE HCL L. Perrigo Company 455b35b4-3969-411b-8036-887615d71e11 2025-12-21 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Safeway Inc. 4a4f7f82-1b6c-7082-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0485-0080-01 00485008001 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0080-01) 2011-11-15 0000-00-00 No No Current