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 3 of 21 · 403 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CONTAC AllergyLORATADINEVespyr Brands LLC4587a61d-139e-2a5b-e063-6394a90a13112026-05-01WarningsExact identifier
application number: ANDA208314
rxcui: 311372
unii: 7AJO3BO7QN
good sense allergy reliefLORATADINEL. Perrigo Company80e8a6e8-0c5f-4065-9545-112e146d25ee2026-04-27WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
MEDIQUE LoradamedLORATADINESportpharm LLCd6bf0e68-f87c-49ee-a15d-df7f5bfa62212026-04-24WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
LoratadineLORATADINEPreferred Pharmaceuticals Inc.7ca5050a-328a-4aff-8954-58f092e3ed6b2026-04-21WarningsExact identifier
application number: ANDA208314
rxcui: 311372
unii: 7AJO3BO7QN
good sense childrens allergy reliefLORATADINEL. Perrigo Company643dfe16-9cd1-47bb-8bce-303e6885c6442026-04-20WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine 10mgLORATADINEBETTER LIVING BRANDS, LLC46d615dd-45d5-2dfc-e063-6394a90a5d422026-04-18WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
All Day Allergy ReliefLORATADINEWALMART INC. (see also Equate)80958503-400c-422a-a641-e1a3d5a9a6a82026-04-17WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINECamber Consumer Care Inc4dec6d48-78e0-48a4-9274-25f6cbf26a2c2026-04-10WarningsExact identifier
unii: 7AJO3BO7QN
allergy relief d 12LORATADINE, PSEUDOEPHEDRINE SULFATEWalgreen Company7e6ea563-cc79-4683-b600-0691e0fb78ab2026-04-09WarningsExact identifier
unii: 7AJO3BO7QN
Childrens LoratadineLORATADINESun Pharmaceutical Industries, Inc.78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d02026-04-08WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINENuCare Pharmaceuticals,Inc.16f00a3a-0777-f70c-e063-6294a90a71c92026-04-06WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
ALLERGY RELIEF 10 mgLORATADINETWIN MED LLCd943f548-aa0d-4476-e053-2a95a90a7bd42026-04-01WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
ALLERGY RELIEFLORATADINECARDINAL HEALTH 110, LLC. DBA LEADER052e0ea2-441f-42cc-b62c-f2574f995bff2026-03-31WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINESafecor Health, LLC14d1ecf5-d694-4ce0-87e4-df27f3f4d9092026-03-31WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LORATADINELORATADINECVS HEALTH CORP899800a7-89bc-4a39-88b0-f19d78934daf2026-03-26WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINECVS Pharmacy, Inc.3937f769-e8e2-4b32-8338-21b0a74a86972026-03-20WarningsExact identifier
application number: ANDA208314
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine Allergy ReliefLORATADINEPD-Rx Pharmaceuticals, Inc.7127b39d-3686-4249-b720-43c02b4c46542026-03-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Childrens Loratadine OralLORATADINEA-S Medication Solutions0a42baae-554b-4b93-8780-fe45c42fabc02026-03-18WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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