FDA.reportPublic FDA data

NDC 51672-2131-01 - Childrens Loratadine Sugar Free

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
51672-2131
Requested NDC
51672-2131-01
Package NDCs from labels
51672-2131-4, 51672-2131-8, 51672-2131-1, 51672-2131-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | Taro Pharmaceutical Industries, Ltd.
Effective date
2026-08-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Childrens Loratadine Oral Solution Sugar FreeSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | Taro Pharmaceutical Industries, Ltd.2026-08-30HUMAN OTC DRUG LABEL
Childrens Loratadine Oral Solution Sugar FreePreferred Pharmaceuticals Inc.2026-01-15HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2131-1Childrens LoratadineSugar Free1 in 1 CARTONSOLUTION14
51672-2131-1Childrens LoratadineSugar Free240 mL in 1 BOTTLESOLUTION2404
51672-2131-4Childrens LoratadineSugar Free60 mL in 1 BOTTLESOLUTION604
51672-2131-4Childrens LoratadineSugar Free1 in 1 CARTONSOLUTION14
51672-2131-8Childrens LoratadineSugar Free120 mL in 1 BOTTLESOLUTION1204
51672-2131-8Childrens LoratadineSugar Free1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2131CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 6 package rows20230805_58eaab62-ac36-4080-8ded-9b472dddc617.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2131-8ML - Milliliter51672-21313ff51a3e-245f-4e75-a21e-7fe62e546dfd12018-02-20

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 40 of 61 · 1,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefLORATADINECHAIN DRUG MARKETING ASSOCIATION, INC.e0cb8057-4755-482d-84f4-9275f7b85cd02024-08-12WarningsExact identifier
unii: 7AJO3BO7QN
Up and Up Hemorrhoid MAX STRENGTH14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUMTarget Corporation867677b5-fd1d-449e-966e-1de0b5c98afb2024-08-08WarningsExact identifier
unii: PDC6A3C0OX
allergy reliefLORATADINEMeijer Distribution Inc9261a02b-db43-462f-9f06-fb5624070e202024-08-06WarningsExact identifier
unii: 7AJO3BO7QN
UP AND UP CHILDRENS ALLERGYLORATADINETarget Corporationa9f6ae02-cf29-4111-99e7-7e6b1ecb88f02024-07-31WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
DrainageECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUMBioActive Nutritional, Inc.7920e8f6-be48-4402-9085-9673779db5a22024-07-31WarningsExact identifier
unii: E4GA8884NN
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, ARSENICUM IODATUM, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.09d87efd-9ae3-45ea-8bb6-3e507ae31cfb2024-07-29WarningsExact identifier
unii: E4GA8884NN
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: E4GA8884NN
Adrenal SupportARALIA QUINQUEFOLIA, HUMULUS LUPULUS, ADRENALINUM, CORTISONE ACETICUM, SELENIUM METALLICUM, THYROIDINUM (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, FERRUM METALLICUM, NUX VOMICA, PHOSPHORUS, SEPIA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.50f48780-b222-471a-afa5-1504960d48942024-07-29WarningsExact identifier
unii: E4GA8884NN
Childrens AllergyLORATADINECVS Pharmacy13c40819-24af-48f1-8371-9e32dc5339a12024-07-26WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
24 / 7 Life Non-Drowsy Allergy ReliefLORATADINE TABLETLil' Drug Store Products, Inc.efd0703f-f069-566e-e053-2995a90a74e42024-07-22WarningsExact identifier
unii: 7AJO3BO7QN
Adrenal HomeopathicCAPSICUM ANNUUM, GLANDULA SUPRARENALIS SUIS, FERRUM METALLICUM, AMMONIUM MURIATICUM, KALI CARBONICUM, NUX VOMICA, PHOSPHORICUM ACIDUMEnergique, Inc.5fe2ae3c-75ca-4907-ac4c-905d34cc5b802024-07-16WarningsExact identifier
unii: E4GA8884NN
AdditivestatTRIFOLIUM PRATENSE, PETROLEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, NITRICUM ACIDUMEnergique, Inc.8a9490c2-1fdb-43b4-aeae-6e783b333f032024-07-16WarningsExact identifier
unii: E4GA8884NN
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Zenibell Snail IntensiveCreamGLYCERINMISOCOS97c19dca-237c-c968-e053-2a95a90aeae72024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Zenibell Snail Intensive TonerGLYCERINMISOCOS97c1b556-824d-bef7-e053-2a95a90ae1f22024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma HydrocellGLYCERINMISOCOS980fcaea-27ba-da49-e053-2995a90ad5062024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma Hydrocell 24k Gold SerumGLYCERINMISOCOSa17b2c6e-9db8-bae4-e053-2a95a90adcf62024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Bunnies Bum Soothing HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLFloCal Distributors LLC1c81582c-7ece-182f-e063-6294a90a8fbc2024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Zenibell Snail IntensiveGLYCERINMISOCOS97747267-26f1-d06f-e053-2a95a90ab0872024-07-04WarningsExact identifier
unii: PDC6A3C0OX
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAYEnergique, Inc.c3d2fd24-6b41-4c85-bd5f-c3306e97080e2024-07-03WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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