FDA.reportPublic FDA data

NDC 68084-248-11 - 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
68084-248
Requested NDC
68084-248-11
Package NDCs from labels
68084-248-11, 68084-248-01
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-06-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loratadine - Cardinal Health 107, LLCCardinal Health 107, LLC2026-06-04HUMAN OTC DRUG LABEL
Loratadine - American Health PackagingAmerican Health Packaging2024-11-21HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-248-01Loratadine100 in 1 BOX, UNIT-DOSETABLET1008
68084-248-11Loratadine1 in 1 BLISTER PACKTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-248LORATADINE TABLET [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20241123_411f3692-99ff-49d7-8594-e6f404f5861f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-248-01EA - Each68084-248165b06ea-6df4-4705-ab8d-10bd222c107e12012-07-24
68084-248-11EA - Each68084-248951de69e-80c5-4d40-9701-de374b02ec8b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [AMERICAN HEALTH PACKAGING]2
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [CARDINAL HEALTH]2
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [AMERICAN HEALTH PACKAGING]2
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [CARDINAL HEALTH]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [CARDINAL HEALTH]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [CARDINAL HEALTH]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [CARDINAL HEALTH]2

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 4 of 21 · 403 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS ALLERGY RELIEFLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0e84571d-87b6-4742-ac62-9ed68a115c722026-03-17WarningsExact identifier
unii: 7AJO3BO7QN
allergy relief d 12LORATADINE, PSEUDOEPHEDRINE SULFATECVS Pharmacy0ca2b074-7137-478c-b32c-67f834f6c4542026-03-15WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINENuCare Pharmaceuticals,Inc.c0e3057d-2dd2-de2b-e053-2995a90a1a1d2026-03-05WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Allergy Relief DLORATADINE, PSEUDOEPHEDRINE SULFATEWalgreen Company9952e0fb-b20e-4f9c-8be7-aa286e271fee2026-02-28WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINEPD-Rx Pharmaceuticals, Inc.039f144b-891b-4ab0-e063-6394a90aa4c82026-02-26WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINEPD-Rx Pharmaceuticals, Inc.775885f9-0580-4eca-94d8-44fce1dcdccd2026-02-26WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEATLANTIC BIOLOGICALS CORP.999a1080-5bbd-4027-b6e7-a90a6941ee272026-02-26WarningsExact identifier
unii: 7AJO3BO7QN
Dr Simi All Day Allergy ReliefLORATADINEFarmacias De Similares TX LLC3c5b2eaa-24da-3314-e063-6294a90a5b212026-02-26WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
allergy reliefLORATADINECVS Pharmacy0038bc38-c205-4d8d-ab78-1abbcd76829e2026-02-25WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
allergy reliefLORATADINEKroger Company745d48f2-504d-4e3d-abf8-768d201cf8142026-02-24WarningsExact identifier
unii: 7AJO3BO7QN
Alavert AllergyLORATADINEFoundation Consumer Brandsf741d1cf-0ecb-4405-8596-07af394537db2026-02-23WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine Allergy ReliefLORATADINEA-S Medication Solutionsa53e5635-8633-4c28-b04f-cdfb3d851e682026-02-19WarningsExact identifier
application number: ANDA076134
rxcui: 311372
unii: 7AJO3BO7QN
Berkley and Jensen Allergy ReliefLORATADINEBJWCe981a0ef-08e9-4ac3-92a1-411217e0a2512026-02-16WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEMajor Pharmaceuticals60162446-4fa1-4ee3-ae20-19fadc2491ab2026-02-09WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINESportpharm LLC2b432b67-f9f3-45e2-8306-2d4080152f992026-02-06WarningsExact identifier
unii: 7AJO3BO7QN
loratadine DLORATADINE, PSEUDOEPHEDRINE SULFATESportpharm LLCbb54f613-b2ab-48fd-83c9-2038ec7097f62026-02-06WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Loratadine OralLORATADINEAtlantic Biologicals4a1a6981-133c-d45b-e063-6294a90a4a092026-02-05WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEKroger Companydac0b200-6b02-4c8a-b1dd-a4d5341dfb2d2026-02-05WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEStrategic Sourcing Services, LLCa527f83a-4ae9-47b1-94e0-7ab3148b025f2026-01-29WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEHyVee Incb6ee2b7f-8e01-4962-b28f-91e5cac852762026-01-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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