FDA.reportPublic FDA data

NDC 70000-0654-01 - Leader Acid Reducer

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
70000-0654
Requested NDC
70000-0654-01
Package NDCs from labels
70000-0654-1, 70000-0654-01
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-08-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leader Acid Reducer - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2025-08-21HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0654-1Leader Acid Reducer1 in 1 CARTONTABLET, FILM COATED14
70000-0654-1Leader Acid Reducer50 in 1 BOTTLETABLET, FILM COATED504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0654LEADER ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, 2 package rows20250212_321b83f9-4bbf-494a-9279-80b0742049b6.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 76 of 147 · 2,936 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3b21f1d8-534d-f4ea-e063-6294a90ad2eb2025-08-21WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3ceb3368-439c-9f6c-e063-6294a90a98ba2025-08-21WarningsExact identifier
unii: 15FIX9V2JP
Leader Acid ReducerFAMOTIDINECardinal Health 110, LLC. dba Leader321b83f9-4bbf-494a-9279-80b0742049b62025-08-21WarningsExact identifier
application number: ANDA077351
ndc (package): 70000-0654-1
ndc (product): 70000-0654
ndc11 (package): 70000065401
rxcui: 310273
spl id: 563bca3a-1a43-4520-ac66-3aecd0d3c5fd
spl set id: 321b83f9-4bbf-494a-9279-80b0742049b6
unii: 5QZO15J2Z8
foster and thrive acid reducerFAMOTIDINEStrategic Sourcing Services LLC0c480ba4-b07e-4109-a9a9-5480b4a39a1d2025-08-21WarningsExact identifier
application number: ANDA077351
rxcui: 310273
unii: 5QZO15J2Z8
members mark acid pepFAMOTIDINESam's West Incf9f4a91c-60a2-4893-88e6-639d242373752025-08-21WarningsExact identifier
application number: ANDA077351
rxcui: 310273
unii: 5QZO15J2Z8
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cc8b151-c07d-7473-e063-6294a90a1cc72025-08-20WarningsExact identifier
unii: 15FIX9V2JP
SEYEZINC OXIDE AND TITANIUM DIOXIDE CREAMGuangzhou Seye Biomedical Technology Co., Ltd.3cce91b1-311b-4c95-e063-6294a90a2d7a2025-08-20WarningsExact identifier
unii: 15FIX9V2JP
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Inc.0c3ed6fe-8dce-0496-e063-6394a90add562025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.93e05175-001b-c639-e053-2a95a90a289c2025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.9b4276af-b738-3293-e053-2a95a90ad0222025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Sun Bum 30 Mineral Sunscreen Face 1.7 OZTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3b1729c5-d8ca-94c7-e063-6394a90a67a52025-08-18WarningsExact identifier
unii: 15FIX9V2JP
MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCea4d564f-ac64-abac-e053-2a95a90a8abb2025-08-15WarningsExact identifier
unii: 15FIX9V2JP
TopCare Acid ReducerFAMOTIDINETopco Associates LLCc3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe2025-08-15WarningsExact identifier
application number: ANDA077351
rxcui: 310273
unii: 5QZO15J2Z8
Sun Bum 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a263b85-e7a0-c068-e063-6294a90a49f22025-08-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Bum 50 Mineral Sunscreen Roll-OnTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a392237-019d-2384-e063-6394a90a5b242025-08-14WarningsExact identifier
unii: 15FIX9V2JP
dual action completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEPublix Super Markets Inc913073fe-22ce-40a3-ad22-bf3027c21e992025-08-14WarningsExact identifier
unii: 5QZO15J2Z8
Rugby FamotidineFAMOTIDINERugby Laboratoriescdb6caa5-5be6-4597-a930-b8c816ac30402025-08-13WarningsExact identifier
application number: ANDA077351
rxcui: 310273
unii: 5QZO15J2Z8
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd617303f8-4463-4a1e-a502-44abc181d91f2025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd03153d92-dc68-4b84-a8c9-634b1ffd7da12025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c457455-b9b1-546b-e063-6294a90a41f62025-08-13WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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