FDA.reportPublic FDA data

NDC 70677-1018-01 - Loratadine and Pseudoephedrine

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
70677-1018
Requested NDC
70677-1018-01
Package NDCs from labels
70677-1018-1, 70677-1018-2, 70677-1018-01
Manufacturer
STRATEGIC SOURCING SERVICES LLC | Ohm Laboratories Inc.
Effective date
2023-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DRUG FACTSSTRATEGIC SOURCING SERVICES LLC | Ohm Laboratories Inc.2023-08-11HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1018-1Loratadine and Pseudoephedrine10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE101
70677-1018-1Loratadine and Pseudoephedrine1 in 1 CARTONTABLET, EXTENDED RELEASE11
70677-1018-2Loratadine and Pseudoephedrine1 in 1 CARTONTABLET, EXTENDED RELEASE11
70677-1018-2Loratadine and Pseudoephedrine15 in 1 BLISTER PACKTABLET, EXTENDED RELEASE151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1018LORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 4 package rows20230818_07f03186-438d-41b7-a871-f05a38733329.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1018-1EA - Each70677-1018c70a5ed5-0cab-4db4-9a38-c79de4024b2612024-01-04
70677-1018-2EA - Each70677-1018a181b71e-4e91-4fca-8d31-00078819f40212024-01-04

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 95 of 189 · 3,774 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: ETJ7Z6XBU4
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEMajor Pharmaceuticals2620a150-4a2c-4fa2-a0e4-6aafe9e496c32025-09-08WarningsExact identifier
application number: ANDA076557
rxcui: 1117562
unii: Y9DL7QPE6B
unii: 7AJO3BO7QN
McKesson Antacid Calcium CarbonateCALCIUM CARBONATEMcKesson Medical-Surgicalbdac6778-384c-50bb-e053-2995a90a0e172025-09-08WarningsExact identifier
unii: H0G9379FGK
Thompson AntacidCALCIUM CARBONATEThompsond9524a64-6f35-24a8-e053-2995a90a6ca32025-09-08WarningsExact identifier
unii: H0G9379FGK
Medique AlcalakCALCIUM CARBONATEUnifirst First Aid Corporation60703e3d-52b1-49c4-b4e2-59d96fa09a782025-09-08WarningsExact identifier
unii: H0G9379FGK
Belmora MELOX AGRURACALCIUM CARBONATEBelmora, LLC875f38f8-4e6f-7517-e053-2995a90a21812025-09-08WarningsExact identifier
unii: H0G9379FGK
Unishield AntacidCALCIUM CARBONATEUnishieldb5e4d635-4c15-a849-e053-2995a90ac5612025-09-08WarningsExact identifier
unii: H0G9379FGK
Green Guard Maximum Strength Stomach ReliefCALCIUM CARBONATE 750 MGUnifirst First Aid Corporation692e09bc-2842-adb9-e053-2991aa0aec492025-09-08WarningsExact identifier
unii: H0G9379FGK
PhysiciansCare AntacidCALCIUM CARBONATEAcme United Corporation0e78664a-ccbb-4b8b-a533-a78d243f8ce82025-09-08WarningsExact identifier
unii: H0G9379FGK
Uline AntacidCALCIUM CARBONATEUline9014f295-e816-9bcd-e053-2a95a90ae1032025-09-08WarningsExact identifier
unii: H0G9379FGK
Medique Ban-acid Maximum Strength 750CALCIUM CARBONATEUnifirst First Aid Corporationa8b70bda-89be-4c1c-998b-3d97ceac9fee2025-09-08WarningsExact identifier
unii: H0G9379FGK
D-CALCALCIUM CARBONATEA&Z Pharmaceutical Inc.303bee24-d308-4b16-b382-c5f8180141172025-09-08WarningsExact identifier
unii: H0G9379FGK
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dbb07e2-971c-284d-e063-6294a90a437f2025-09-06WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3e069cb2-c4c5-abf5-e063-6394a90a56b02025-09-06WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.18130858-429c-4ed4-a75b-5bc0144812502025-09-04WarningsExact identifier
unii: 15FIX9V2JP
topcare dual action completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDETopco Associates LLC2c5a1694-d6e9-4679-b421-61eaad5403a42025-09-04WarningsExact identifier
unii: H0G9379FGK
Exchange Select Antacid Soft Chews Cherry FlavorCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de81025-b81c-374a-e063-6394a90a00cf2025-09-03WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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