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 35 of 61 · 1,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LORATADINELORATADINEAMZ789 LLCdb71197e-d633-644d-e053-2a95a90a261d2025-01-08WarningsExact identifier
unii: 7AJO3BO7QN
Emetrol Children Mixed BerryPHOSPHORATED CARBOHYDRATEWellSpring Pharmaceutical Corporationecff699b-d4d8-4407-8119-3e9a1100024a2025-01-08WarningsExact identifier
unii: E4GA8884NN
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: E4GA8884NN
unii: 506T60A25R
Prevention Oncology Mouth RinseGLYCERINPrevention Health Sciences, Inc.1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c2025-01-01WarningsExact identifier
unii: PDC6A3C0OX
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsExact identifier
unii: 6DC9Q167V3
CLENZIDERM THERAPEUTIC MOISTURIZERGLYCERINObagi Cosmeceuticals LLCd60e22e3-831e-4787-a82c-e7763c2875532025-01-01WarningsExact identifier
unii: PDC6A3C0OX
LORATADINELORATADINECVS PHARMACY, INC4e74e322-7f6e-467c-96c0-9b531ddb429b2024-12-31WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINE TABLETLil' Drug Store Products, Inc.f0e77162-c601-1a0f-e053-2a95a90ab7142024-12-31WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEAdvanced Rx Pharmacy of Tennessee, LLC01cb43cf-57a9-f189-e063-6294a90afd882024-12-31WarningsExact identifier
unii: 7AJO3BO7QN
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: 6DC9Q167V3
CHILDRENS LORATADINELORATADINESAFEWAYdad93ac1-ae0b-4918-8c62-92107e79a4b22024-12-29WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEWALGREEN COMPANY645c26ab-08ab-4a69-ae7d-7802d8ec59222024-12-29WarningsExact identifier
unii: 7AJO3BO7QN
Wal-itinLORATADINEWalgreens176fe4f5-f72d-4fc2-bd9a-20626c9ab6342024-12-27WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEPremier Valuedc22862e-fe91-4900-8c2b-1ca45aeedbf02024-12-27WarningsExact identifier
unii: 7AJO3BO7QN
CHILDRENS LORATADINELORATADINETARGET CORPORATIONc02ad905-2363-4092-a90e-3be789112cb12024-12-27WarningsExact identifier
unii: 7AJO3BO7QN
Childrens AllergyLORATADINETARGET CORPORATION9507c223-ea75-477e-b765-f5d0bcba5ff92024-12-27WarningsExact identifier
unii: 7AJO3BO7QN
AllervarxLORATADINEInnovus Pharmaceuticals, Inc.ec4d1e77-6995-4228-8e63-a9ab6232dace2024-12-27WarningsExact identifier
unii: 7AJO3BO7QN
AllervarxLORATADINEInnovus Pharmaceuticals, Inc.885e81ae-5ea3-4d14-8666-8c26987670142024-12-27WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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