FDA.reportPublic FDA data

NDC 70000-0583-01 - Loratadine

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
70000-0583
Requested NDC
70000-0583-01
Package NDCs from labels
70000-0583-1, 70000-0583-2, 70000-0583-01
Manufacturer
Cardinal Health | Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2024-06-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loratadine - Cardinal Health | Aurohealth LLC | Aurobindo Pharma LimitedCardinal Health | Aurohealth LLC | Aurobindo Pharma Limited2024-06-14Human OTC Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0583-1Loratadine10 in 1 BLISTER PACKTABLET104
70000-0583-1Loratadine2 in 1 CARTONTABLET24
70000-0583-2Loratadine30 in 1 BOTTLETABLET304
70000-0583-2Loratadine1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0583LORATADINE TABLET [CARDINAL HEALTH]4Current NDC, Legacy NDC, 4 package rows20240619_c96dd1c9-85a0-0792-e053-2a95a90a2264.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0583-1EA - Each70000-0583818f55c9-805c-4bbe-95b5-0f72fafca22f12022-06-06

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 2 of 21 · 403 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
allergy and nasal congestionLORATADINE, PSEUDOEPHEDRINE SULFATEKroger Company934dda74-7995-46f1-b6f2-f4b928a2eeb22026-07-08WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINE ORALKROGER COMPANYb963d83b-584f-c447-e053-2995a90ad9732026-07-06WarningsExact identifier
unii: 7AJO3BO7QN
dg health allergy reliefLORATADINEDolgencorp Incdfc4b065-1980-48ec-9c3e-aaa4a42214d32026-07-02WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
CareOne Allergy Relief 24 HourLORATADINEAmerican Sales Companybbd5424f-fa5b-4955-8542-7011b19400ea2026-07-01WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINESt. Mary's Medical Park Pharmacy2bc586e4-5297-44cf-e063-6294a90a531d2026-06-29WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
childrens allergy reliefLORATADINEKroger Company52934db1-b6fc-43ca-9a8c-66ff47a947452026-06-29WarningsExact identifier
unii: 7AJO3BO7QN
kirkland signature allerclear d 24 hrLORATADINE, PSEUDOEPHEDRINE SULFATECostco Wholesale Companyc5815ab0-cb32-41ce-9a17-1cd87a66cdde2026-06-24WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINECardinal Health 107, LLC64489b01-a4a7-4c6d-ac84-1dfbd1388d842026-06-04WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEOhm Laboratories Inc.556b89ef-3b51-4faa-afb4-767a5c1b64222026-06-02WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEPreferred Pharmaceuticals Inc.d778c4d2-184a-4dc8-9351-66d81d0618f22026-05-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Good Sense childrens allergy reliefLORATADINEPreferred Pharmaceuticals Inc.27bb0a40-35ee-4c19-bd6f-fb054c8a25862026-05-28WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEPreferred Pharmaceuticals Inc0a0d700d-bdba-4c90-a947-5d61d40ce4df2026-05-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEPreferred Pharmaceuticals Inc.c6144a33-6b33-4aca-86e5-a3f688b8b3172026-05-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
allergy reliefLORATADINERite Aid Corporation5d58ed7a-e40b-417f-a216-5ec6721d361b2026-05-27WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEGrocery Outlet, Inc441cfa86-a812-f67f-e063-6394a90a21182026-05-21WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEAvPAK52581dd2-9597-35cb-e063-6294a90a36c72026-05-21WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Berkley and Jensen Childrens Allergy ReliefLORATADINEBJWC7f9b6a94-2be4-4c96-9a7d-8443f911a4cc2026-05-21WarningsExact identifier
unii: 7AJO3BO7QN
ValuMeds Allergy Relief LoratadineLORATADINECabinet Health P.B.C.43bc8e38-bd74-411c-b4fe-7d809d24ae462026-05-20WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
DYE-FREE LORATADINELORATADINEOhm Laboratories Inc.48744daa-7079-283d-e063-6394a90a2c9a2026-05-05WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEKROGER COMPANYb96831f5-5e75-c526-e053-2995a90a36ad2026-05-04WarningsExact identifier
application number: ANDA208314
rxcui: 311372
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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