Home NDC 70000-0747 Leader Vapor Ice Cold and Flu
Product NDC 70000-0747
11-digit product format 700000747
Labeler code 70000
Product ID 70000-0747_7073cce7-5495-4eb7-978f-54e9c7129e10
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health 110, LLC. dba Leader
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-14
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 10 mg/1; mg/1
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 Leader Vapor Ice Cold and Flu
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2709673 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 70000-0747-1 Leader Vapor Ice Cold and Flu 12 in 1 CARTON TABLET, FILM COATED 12 2 70000-0747-1 Leader Vapor Ice Cold and Flu 2 in 1 BLISTER PACK TABLET, FILM COATED 2 2
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 70 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Quality Choice Honey Lemon Cough Drops HONEY LEMON COUGH DROPS Chain Drug Marketing Association, Inc. 1fd09b04-9c79-da20-e063-6394a90ae263 2025-12-22 Warnings Exact identifier application number: M012 Quality Choice Menthol Cough Drops MENTHOL COUGH DROPS Chain Drug Marketing Association, Inc. 3364470e-d9bb-42a6-9bd5-80c0bed8bc9e 2025-12-22 Warnings Exact identifier application number: M012 Quality Choice Honey Lemon Sugar Free Cough Drops HONEY LEMON SUGAR FREE COUGH DROPS Chain Drug Marketing Association, Inc. 1fd0a790-c67c-216f-e063-6294a90ae971 2025-12-22 Warnings Exact identifier application number: M012 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70000-0747-1 70000074701 12 BLISTER PACK in 1 CARTON (70000-0747-1) / 2 TABLET, FILM COATED in 1 BLISTER PACK 12 blister pack 2026-01-14 No No Current