Home NDC 70000-0764 LEADER
Product NDC 70000-0764
11-digit product format 700000764
Labeler code 70000
Product ID 70000-0764_2212cf9e-6944-4922-b5b5-1373cf10b2e1
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler CARDINAL HEALTH 110, LLC. DBA LEADER
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 1000; 30 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
Brand name suffix Multi Symptom Flu Relief Daytime Max Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 1000 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 30 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 2636656 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 129 of 177 · 3,534 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Childrens Mucus and Cough Relief DEXTROMETHORPHAN HBR, GUAIFENESIN CARDINAL HEALTH 110, LLC. DBA LEADER 125eeb3d-0ee2-45bb-81c0-4ca699979886 2024-12-16 Warnings Exact identifier application number: M012 Dextromethorphan HBr 15 mg Liquid Gels DEXTROMETHORPHAN HBR RUGBY LABORATORIES cf3cc387-6642-43fd-999d-688fdaf65d4f 2024-12-14 Warnings Exact identifier application number: M012 Allergy Relief Dye-Free Softgel DIPHENHYDRAMINE HYDROCHLORIDE CVS PHARMACY, INC 60b1bb79-3ed1-438b-a27f-f7fbc108d114 2024-12-14 Warnings Exact identifier application number: M012 Rycontuss Cherry Flavor CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE Okendpharma, Inc. c91798fa-48ab-47a0-92da-4d44c2aafde0 2024-12-13 Warnings Exact identifier application number: M012 Mentholatum Lavender Vaporizing Rub CAMPHOR, EUCALYPTUS OIL, MENTHOL The Mentholatum Company 6f208c05-617d-492a-a016-e9d6be3c971f 2024-12-13 Warnings Exact identifier application number: M012 CVS Vapor Steam CAMPHOR (SYNTHETIC) CVS 49da2c40-afc5-5770-e054-00144ff88e88 2024-12-13 Warnings Exact identifier application number: M012 Kroger Daytime Cold and Flu Softgel ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE The Kroger Company e428dd83-c538-2a92-e053-2a95a90a0e16 2024-12-13 Warnings Exact identifier application number: M012 Kroger Nighttime Cold and Flu Softgel ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE The Kroger Company e46291c7-6f4d-46a2-e053-2a95a90a80a1 2024-12-13 Warnings Exact identifier application number: M012 Foster and Thrive Childrens Allergy Relief DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 7eaba464-5cdb-4bd4-b272-38fa108658d5 2024-12-13 Warnings Exact identifier application number: M012 SUDAFED OM Sinus Severe Original OXYMETAZOLINE HYDROCHLORIDE Kenvue Brands LLC 1d089074-3969-ce6e-e063-6294a90aa70c 2024-12-12 Warnings Exact identifier application number: M012 RIGHT REMEDIES Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc b4fc014c-7c5f-46a4-bf13-57103b6fa018 2024-12-11 Warnings Exact identifier application number: M012 Diphenhydramine Hydrochloride 25mg DIPHENHYDRAMINE HYDROCHLORIDE 25MG Strive Pharmaceuticals Inc b440eb2e-4de9-2b65-e053-2995a90abda8 2024-12-11 Warnings Exact identifier application number: M012 Meijer Effervescent Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE Meijer Distribution Inc. 6933ca9d-a32d-d856-e053-2a91aa0a408e 2024-12-10 Warnings Exact identifier application number: M012 Effervescent Orange Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE Meijer Distribution Inc. 826b5c0d-7a75-bbf0-e053-2a91aa0aebd6 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 09141018-37ba-4c93-9051-1ed129c448c1 2024-12-10 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola USA Inc. 6ac9d95b-f6b9-4515-b126-697f8f839612 2024-12-10 Warnings Exact identifier application number: M012 THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL Ricola USA Inc. 989d1529-2875-47bf-81df-65494d62be7a 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 82813342-2be2-4731-ae90-dbd5eed667a9 2024-12-10 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. b640a5d2-a7fe-486d-a65f-e7c993f950d6 2024-12-10 Warnings Exact identifier application number: M012 Sugar Free Mountain Herb Cough Suppressant Throat Drops MENTHOL Ricola USA Inc. c3f3c062-55e5-43c1-a016-ee47a7b388a5 2024-12-10 Warnings Exact identifier application number: M012
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70000-0764-1 70000076401 6 PACKET in 1 CARTON (70000-0764-1) / 1 POWDER, FOR SOLUTION in 1 PACKET 6 packet 2026-07-01 No No Current