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 11 of 52 · 1,038 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefLORATADINEHyVee Incb6ee2b7f-8e01-4962-b28f-91e5cac852762026-01-28WarningsExact identifier
unii: 7AJO3BO7QN
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Childrens Loratadine Sugar FreeLORATADINEPreferred Pharmaceuticals Inc.23936948-71bf-4c18-9160-22b7075e675d2026-01-15WarningsExact identifier
application number: ANDA076805
rxcui: 692783
unii: 7AJO3BO7QN
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacya73404d5-7843-4a9a-ad43-613df22f52e72026-01-14WarningsExact identifier
unii: PDC6A3C0OX
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyeff2f43e-5626-48eb-a70e-3344929772042026-01-14WarningsExact identifier
unii: PDC6A3C0OX
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyc92ca67b-bea2-4be0-95ab-15f9b55568c12026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Rite-Aid Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fb8f488-3386-29b9-e063-6294a90a014c2026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Rite-Aid Childrens Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fbe4dfd-1d5d-fc31-e063-6394a90ab3172026-01-14WarningsExact identifier
unii: PDC6A3C0OX
GNP Hemorrhoidal Maximum StrengthHEMORRHOIDALAmerisourcebergen Drug Corporation24103355-cd72-55b0-e063-6394a90a90ec2026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid, Fissure, ProctalgiaSuppositoriesCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1d40d16a-ee52-463a-e063-6394a90a60772026-01-14WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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