FDA.reportPublic FDA data

NDC 62011-0305-01 - Childrens 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
62011-0305
Requested NDC
62011-0305-01
Package NDCs from labels
62011-0305-1, 62011-0305-01
Manufacturer
Strategic Sourcing Services LLC | Taro Pharmaceutical Industries Ltd.
Effective date
2024-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Children's LoratadineStrategic Sourcing Services LLC | Taro Pharmaceutical Industries Ltd.2024-12-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0305-1Childrens Loratadine120 mL in 1 BOTTLESOLUTION1204
62011-0305-1Childrens Loratadine1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0305CHILDRENS LORATADINE (LORATADINE) SOLUTION [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20241222_280739e5-94e5-4d1e-ba65-2b4304cbac97.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0305-1ML - Milliliter62011-03055b559a22-b553-4961-9c4a-1b79f5239e0d12017-11-06

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 52 of 52 · 1,038 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: OJ245FE5EU
LORATADINELORATADINERite Aid11926331-f6b8-4590-9dcd-755a9d9468412018-06-12WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEHEB0504f63e-e89c-49ad-9094-65fac328482e2018-05-24WarningsExact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINESMART SENSE (KMART)c2db3398-ead6-4bb6-8aa6-f1366a8461442018-05-16WarningsExact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINETIME CAP LABORATORIES INC85b26cf3-448c-4d4f-93a2-aa89530ec1f12018-05-16WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine Allergy ReliefLORATADINEHEB6703e4f3-e9b8-4c70-9085-3d6ac0d7fbda2018-05-14WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEHEB74e7670a-5eca-4556-a860-0d36e85615182018-04-12WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEPremier Value778a6979-ea47-4381-8c40-84b3c2325a7e2018-01-11WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine Allergy ReliefLORATADINELIDL US, LLC11bc027c-d28d-45f0-a4cb-24a3834a69952018-01-09WarningsExact identifier
unii: 7AJO3BO7QN
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Childrens AllergyLORATADINECVS Pharmacydc5f58ef-baf0-4de4-9f6d-aedee419b59b2017-10-02WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
AllergyLORATADINESelder, S.A. de C.V.afdb0117-dd2d-4ab1-a2f4-2a88b6bf52512016-12-22WarningsExact identifier
unii: 7AJO3BO7QN
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LoratadineLORATADINEMylan Pharmaceuticals Inc.3b307aea-5a68-4c82-959a-cda4ffbd0a4a2013-11-15WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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