Home NDC 0363-5789 Ephedrine Sulfate
Product NDC 0363-5789
11-digit product format 003635789
Labeler code 0363
Product ID 0363-5789_3dfc301d-e264-adb0-e063-6394a90aed25
Type HUMAN OTC DRUG
Nonproprietary name Ephedrine Sulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Walgreen Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-22
Substance EPHEDRINE SULFATE
Active strength 25 mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-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 Ephedrine Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPHEDRINE SULFATE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U6X61U5ZEG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1116194 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 0363-5789-07 Ephedrine Sulfate 5 in 1 CARTON TABLET, FILM COATED 5 4 0363-5789-07 Ephedrine Sulfate 12 in 1 BLISTER PACK TABLET, FILM COATED 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-5789 EPHEDRINE SULFATE TABLET, FILM COATED [WALGREEN COMPANY] 3 Current NDC, Legacy NDC, 2 package rows 20241208_dc0072f9-7111-1af0-e053-2a95a90aed56.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 75 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Honey Lemon Cough Drop MENTHOL HEB 3a30a427-6ab4-24ae-e054-00144ff88e88 2025-12-13 Warnings Exact identifier application number: M012 Mixed Berry Sore Throat and Cough Lozenges BENZOCAINE HEB 3063ea93-6bc2-1d18-e054-00144ff88e88 2025-12-13 Warnings Exact identifier application number: M012 HEB Menthol Cough Drops MENTHOL HEB c197855d-15b4-38fc-e053-2a95a90a2dc7 2025-12-13 Warnings Exact identifier application number: M012 HEB SF Honey Lemon Cough Drops MENTHOL HEB d09ed4bb-7595-5e54-e053-2a95a90aa109 2025-12-13 Warnings Exact identifier application number: M012 HEB Cherry Cough Drops MENTHOL HEB c198e3c7-5ba7-ece6-e053-2995a90adb38 2025-12-13 Warnings Exact identifier application number: M012 HEB Honey Lemon Cough Drops MENTHOL HEB c19a79bc-9872-2e87-e053-2a95a90a9427 2025-12-13 Warnings Exact identifier application number: M012 Cold and Flu Daytime Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL WALMART INC. 26f55169-4b37-4a36-88ee-064d6e962065 2025-12-12 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL Walgreen Company 39ce76a3-b7a8-43be-9b61-5c1446cd9e90 2025-12-12 Warnings Exact identifier application number: M012 Cold and Flu maximum strength ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Rite Aid Corporation ac01206f-a717-4c0b-8a03-fab0a4fd154b 2025-12-12 Warnings Exact identifier application number: M012 Sinus Severe ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL Strategic Sourcing Services LLC dcb80dd5-465d-4792-947a-3044e25a5284 2025-12-12 Warnings Exact identifier application number: M012 Vapor Rub COUGH SUPPRESSANT Neilmed Pharmaceuticals Inc. 39190f9f-8a5a-e4d8-e063-6294a90a57dd 2025-12-12 Warnings Exact identifier application number: M012 Allergy Relief, 24-7 Life by 7-Eleven DIPHENHYDRAMINE HCL TABLET, FILM COATED Lil' Drug Store Products, Inc. 45c4cd6c-327d-5950-e063-6394a90a3a21 2025-12-12 Warnings Exact identifier application number: M012 Menthol cough drops MENTHOL Family Dollar 44bb3b95-b2ba-470e-e054-00144ff88e88 2025-12-12 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Family Dollar 44bb9c7b-994b-4ab8-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44be9837-f15a-09f2-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44bcae39-2389-09ee-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 46635813-66c4-504c-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 455b0f4b-0526-2361-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 Family Wellness Strawberry Cough Drops MENTHOL Family Dollar f92466ac-dd93-9ac5-e053-6294a90a9291 2025-12-12 Warnings Exact identifier application number: M012 GoodSense Menthol Cough Drops MENTHOL Geiss, Destin, Dunn c6b25d69-8930-6867-e053-2a95a90ad208 2025-12-12 Warnings Exact identifier application number: M012
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 0363-5789-07 00363578907 5 BLISTER PACK in 1 CARTON (0363-5789-07) / 12 TABLET, FILM COATED in 1 BLISTER PACK 5 blister pack 2022-07-22 0000-00-00 No No Current