FDA.reportPublic FDA data

NDC 70000-0722-01 - Leader Mucus Relief DM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70000-0722
Requested NDC
70000-0722-01
Package NDCs from labels
70000-0722-1, 70000-0722-01
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2026-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leader Mucus Relief DM - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2026-09-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0722-1Leader Mucus Relief DM1 in 1 CARTONTABLET, EXTENDED RELEASE12
70000-0722-1Leader Mucus Relief DM20 in 1 BOTTLETABLET, EXTENDED RELEASE202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0722LEADER MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]2Current NDC, 2 package rows20250315_7c54d128-9da7-49d7-bda4-9d4f7b8bc652.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0722-1EA - Each70000-072249c38113-126c-41f6-bad8-62d50c5d8db512025-10-14

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 3 of 158 · 3,149 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLKROGER COMPANY1ff037ea-1a3b-430a-be31-2e240cc3b6f32026-09-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
KROGER Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINKROGER COMPANY79d24014-1af7-4d62-bcb8-5bea76a7d6ee2026-09-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
unii: 9D2RTI9KYH
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Leader Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leader7c54d128-9da7-49d7-bda4-9d4f7b8bc6522026-09-01WarningsExact identifier
application number: ANDA207602
ndc (package): 70000-0722-1
ndc (product): 70000-0722
ndc11 (package): 70000072201
rxcui: 1298324
spl id: 00d1560d-9781-4c69-b051-dc92235f0db1
spl set id: 7c54d128-9da7-49d7-bda4-9d4f7b8bc652
unii: 9D2RTI9KYH
unii: 495W7451VQ
MAX Tussin Cough and Chest Congestion DM Sugar FreeDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.5c4c8115-cec9-4f2c-9ea9-328535e97b072026-09-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Dextromethorphan HBrDEXTROMETHORPHAN HBRBIONPHARMA INC.5a5dde85-8785-8149-e063-6294a90a4d572026-08-31WarningsExact identifier
unii: 9D2RTI9KYH
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEFDEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOLReckitt Benckiser LLC8d670d91-9e22-45b9-b568-5b62c2133d322026-08-31WarningsExact identifier
unii: 9D2RTI9KYH
Daytime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpe85b4c2a-d4e0-452c-9a08-fcc0ff6eaa212026-08-31WarningsExact identifier
unii: 9D2RTI9KYH
Daytime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp67849e09-2056-4013-98b1-d003ed3250a22026-08-31WarningsExact identifier
unii: 9D2RTI9KYH
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsExact identifier
unii: 495W7451VQ
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsExact identifier
unii: 495W7451VQ
MAX Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.e0ce4287-bfa1-4413-97c8-4fe2e39bda362026-08-31WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDESelect Consumer Group3c9c8fb0-8a00-4b0f-e063-6394a90af6322026-08-30WarningsExact identifier
rxcui: 1298324
unii: 9D2RTI9KYH
unii: 495W7451VQ
Tussin DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED432d4833-2eaf-4f7c-b6b4-41043a6b7e2a2026-08-28WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Maximum Strength Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRWal-Mart Stores, Inc.ff7280e7-804b-423d-add8-54ec2c76fca22026-08-28WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Companyd8a693f7-03c1-4583-89a8-8d506a894b242026-08-28WarningsExact identifier
application number: ANDA207602
rxcui: 1298324
unii: 9D2RTI9KYH
unii: 495W7451VQ
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
unii: NBZ3QY004S

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.