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 54 of 61 · 1,201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
ErogetoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIAEnergique, Inc.1e872ecd-e7a5-463d-9832-47b7046096db2022-06-28WarningsExact identifier
unii: E4GA8884NN
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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.37a7f63c-4241-492b-af7c-7e5bbe0a08892022-06-21WarningsExact identifier
unii: E4GA8884NN
Loratadine ODTLORATADINEAurohealth LLCa6e04fe7-23d3-47d7-9f18-5c4298fbc28b2022-06-20WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEBluePoint Laboratoriesadc506ed-7a7a-facc-e053-2a95a90ae1472022-06-20WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEAurohealth LLCc6bfb54a-04d8-41c1-9fa9-5d4bae0a66d12022-06-18WarningsExact identifier
unii: 7AJO3BO7QN
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dye-Free Childrens LoratadineLORATADINERITE AID322d9a03-a908-4858-b25e-6eba2411fa032022-06-02WarningsExact identifier
unii: 7AJO3BO7QN
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
unii: E4GA8884NN
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINE SULFATERite Aidbb0f7653-378f-40b1-8ead-77999fcbd87b2022-05-09WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEAAA PHARMACEUTICAL, INC.9c8535e3-6a60-4640-b37e-a2260936d9af2022-04-21WarningsExact identifier
unii: 7AJO3BO7QN
signature care allergy reliefLORATADINESafeway0a4b8eef-762e-42cc-84ee-0018a9a3be582022-04-04WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINEProficient Rx LPe9b87f79-ebed-4677-8e50-00cb4282ee562022-04-01WarningsExact identifier
unii: 7AJO3BO7QN
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Leader Allergy Relief D-24LORATADINE AND PSEUDOEPHEDRINE SULFATECardinal Healthf1bcd2aa-e8cd-4364-87b4-c544537cdb502022-03-22WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINERising Pharmaceuticals, Incd28128a3-af54-440e-9bd4-0fccf393d18a2022-03-10WarningsExact identifier
unii: 7AJO3BO7QN
STRESS / FATIGUEEPINEPHRINE, THYROID UNSPECIFIED,BOS TAURUS PITUITARY GLAND, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE CRUDE, CONIUM MACULATUM FLOWERING TOP, CORTISONE ACETATE, CROTALUS HORRIDUS HORRIDUS VENOM, IRON, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, SELENIUM, SEPIA OFFICINALIS JUICE, ZANTHOXYLUM AMERICANUM BARKNatural Creations, Inc.4c28ec7f-4490-4106-8472-d94c7073c3062022-03-03WarningsExact identifier
unii: E4GA8884NN
VIRAL HPARSENIC TRIOXIDE, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, LYCOPODIUM CLAVATUM SPORE, PHOSPHORIC ACID, PHOSPHORUS, RANCID BEEF, TOXICODENDRON PUBESCENS LEAFZorex International1e1bed7c-4af9-4276-85a3-57ebe1d19d4b2022-03-03WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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