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 14 of 194 · 3,866 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
unii: 15FIX9V2JP
LoratadineLORATADINECardinal Health 107, LLC64489b01-a4a7-4c6d-ac84-1dfbd1388d842026-06-04WarningsExact identifier
unii: 7AJO3BO7QN
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
VitaluxMULTIVITAMINPureTek Corporation52d5eee7-8146-cc62-e063-6394a90a8c3f2026-06-02Boxed warning, Adverse reactionsExact identifier
unii: H0G9379FGK
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEOhm Laboratories Inc.556b89ef-3b51-4faa-afb4-767a5c1b64222026-06-02WarningsExact identifier
application number: ANDA076557
rxcui: 1117562
unii: Y9DL7QPE6B
unii: 7AJO3BO7QN
Antacid- Calcium CarbonateCALCIUM CARBONATEAnhui Jiuhe Health Industry Co., Ltd53518897-5387-38cf-e063-6394a90aa3e12026-06-02WarningsExact identifier
unii: H0G9379FGK
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Good Neighbor Pharmacy Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmerisource Bergenb7453c0e-b452-409b-a324-83fdd105bfd02026-06-02WarningsExact identifier
unii: H0G9379FGK
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
unii: 15FIX9V2JP
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDESavings Distributors LLC549136d5-8f2c-d417-e063-6394a90a23e42026-06-01WarningsExact identifier
unii: H0G9379FGK
Regular Strength Antacid PeppermintCALCIUM CARBONATEHyvee Inc4e5526a8-d9ad-965b-e063-6294a90a83332026-06-01WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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