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 32 of 52 · 1,038 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens LoratadineLORATADINEStrategic Sourcing Services LLC280739e5-94e5-4d1e-ba65-2b4304cbac972024-12-19WarningsExact identifier
application number: ANDA076805
ndc (package): 62011-0305-1
ndc (product): 62011-0305
ndc11 (package): 62011030501
rxcui: 692783
spl id: 29a3b58c-79eb-2168-e063-6394a90ac032
spl set id: 280739e5-94e5-4d1e-ba65-2b4304cbac97
unii: 7AJO3BO7QN
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
unii: PDC6A3C0OX
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
unii: PDC6A3C0OX
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
unii: PDC6A3C0OX
LoratadineLORATADINESpirit Pharmaceuticals LLCaf0cdab2-27a4-5f30-e053-2a95a90a5e712024-12-13WarningsExact identifier
unii: 7AJO3BO7QN
foster and thrive allergy reliefLORATADINEStrategic Sourcing Services LLCaff1ab34-51b0-488c-931e-c95aad2265722024-12-11WarningsExact identifier
unii: 7AJO3BO7QN
good neighbor pharmacy loratadineLORATADINEAmerisource Bergen9dda0f0b-fbab-47ee-8db8-95bd126fc61c2024-12-11WarningsExact identifier
unii: 7AJO3BO7QN
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Childrens Loratadine Sugar FreeLORATADINEAmerican Sales Company6977d7e0-9d01-4f5e-8d55-98dabb7195852024-12-09WarningsExact identifier
application number: ANDA076805
rxcui: 692783
unii: 7AJO3BO7QN
Burts Bees Rapid Rescue Cold Sore TreatmentCAMPHOR, GLYCERINBurts Bees9f89735d-205f-4d3e-a1e1-ecc96284fe982024-12-03WarningsExact identifier
unii: PDC6A3C0OX
exchange select allergy reliefLORATADINEArmy & Air Force Exchange Serviceea5622d9-4e71-4a1f-9200-6b4cecac12152024-12-02WarningsExact identifier
unii: 7AJO3BO7QN
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Loratadine 10mgLORATADINE 10MGMARKSANS PHARMA LIMITED3360d02d-612d-4cc5-acc9-2cc93713c3872024-11-25WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEStrategic Sourcing Services LLCcdecad62-bf1e-43fb-b4be-8fc54b63e4ae2024-11-22WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEAmerican Health Packaging411f3692-99ff-49d7-8594-e6f404f5861f2024-11-21WarningsExact identifier
unii: 7AJO3BO7QN
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
unii: 6DC9Q167V3
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEStrategic Sourcing Services LLC48bfc938-d97d-4b49-8637-3b00ac8709022024-11-21WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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