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 25 of 61 · 1,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
unii: PDC6A3C0OX
Fibromyalgia SupportACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CONIINUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI BICHROMICUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, URICUM ACIDUMThe Magni Company36892361-994e-4a6d-972a-9ea9b72f89fe2025-10-09WarningsExact identifier
unii: E4GA8884NN
Homeopathic Pick Up DropsGELSEMIUM SEMPERVIRENS ROOT 12X, MATRICARIA CHAMOMILLA12X, ARNICA MONTANA WHOLE 12X,, PHOSPHORIC ACID 12X, ANEMONE PULSATILLA 12X, ACONITUM NAPELLUS 12X, STRYCHNOS NUX-VOMICA SEED 12XHISTORICAL REMEDIES LLP.0dfcc558-614d-4552-b45d-01402edcc4e92025-10-07WarningsExact identifier
unii: E4GA8884NN
Homeopathic Calm DropsARSENIC TRIOXIDE 30C, MATRICARIA CHAMOMILLA12X, ARABICA COFFEE BEAN 30X, POTASSIUM CARBONATE30C, STRYCHNOS IGNATII SEED30X, LACHESIS MUTA VENOM12X, PHOSPHORIC ACID 3X, ANEMONE PULSATILLA 12C, VALERIAN 30C, ACONITUM NAPELLUS 6X, CHLORIDE ION 12X, STRYCHNOS NUX-VOMICA SEED 30CHISTORICAL REMEDIES LLP.69c35bc2-b9a0-4bb4-a56d-0e2d1c3f79582025-10-07WarningsExact identifier
unii: E4GA8884NN
Homeopathic Stress MintsAGRIMONIA EUPATORIA 3X, MATRICARIA CHAMOMILLA 12X, ARNICA MONTANA 12X, PHOSPHORIC ACID 12X, AVENA SATIVA FLOWERING TOP 3X, STRYCHNOS IGNATII SEED 12X, ANEMONE PULSATILLA 12X, ACONITUM NAPELLUS 12X, STRYCHNOS NUX VOMICA SEED 12XHistorical Remedies LLP828d0f4d-915e-4340-bb98-62cd17eb970b2025-10-07WarningsExact identifier
unii: E4GA8884NN
SinuLiefLORATADINERoseWell Pharmaceuticals LLC32619143-a782-3497-e063-6394a90aaaec2025-10-06WarningsExact identifier
unii: 7AJO3BO7QN
ALLERGY RELIEFLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED31cb3c06-7e15-4000-b169-50b66c14b01b2025-10-06WarningsExact identifier
unii: 7AJO3BO7QN
FNG IECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, CONDURANGO, GINKGO BILOBA, LIGUSTICUM PORTERI, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (BOVINE), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SEPIA, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, TORULA CEREVISIAE, MUCOR RACEMOSUS, RHIZOPUS NIGRICANS.BioActive Nutritional, Inc.c3dfd199-ac9b-450f-9459-721e100fa56a2025-10-06WarningsExact identifier
unii: E4GA8884NN
allergy dLORATADINE, PSEUDOEPHEDRINE SULFATEL. Perrigo Company512f8f46-5c62-470d-b14a-93b86ec34ce82025-10-03WarningsExact identifier
unii: 7AJO3BO7QN
Xpect Industrial Eye ReliefGLYCERIN, NAPHAZOLINE HCLCintas Corporationa0167d06-7adb-36f4-e053-2a95a90af9ef2025-09-30WarningsExact identifier
unii: PDC6A3C0OX
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
unii: PDC6A3C0OX
First Aid Direct Allergy ReliefLORATADINE TABLETSCintas Corporation6b43e5a5-30a8-46ca-a44d-1e1abf567b512025-09-23WarningsExact identifier
unii: 7AJO3BO7QN
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh RelievaCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.6b984fa2-4187-45ef-b7d3-15e720abc6672025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: 6DC9Q167V3
Loratadine antihistamineLORATADINEPadagis Israel Pharmaceuticals Ltdc72d8a30-520e-4d25-8f02-0c891e070a1a2025-09-12WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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