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 13 of 61 · 1,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Childrens Loratadine Sugar FreeLORATADINEPreferred Pharmaceuticals Inc.23936948-71bf-4c18-9160-22b7075e675d2026-01-15WarningsExact identifier
application number: ANDA076805
ndc (package): 68788-8286-1
ndc (product): 68788-8286
rxcui: 692783
spl id: db859005-a53d-4de0-aaf8-25c78b746244
spl set id: 23936948-71bf-4c18-9160-22b7075e675d
unii: 7AJO3BO7QN
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacya73404d5-7843-4a9a-ad43-613df22f52e72026-01-14WarningsExact identifier
unii: PDC6A3C0OX
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyeff2f43e-5626-48eb-a70e-3344929772042026-01-14WarningsExact identifier
unii: PDC6A3C0OX
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyc92ca67b-bea2-4be0-95ab-15f9b55568c12026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Rite-Aid Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fb8f488-3386-29b9-e063-6294a90a014c2026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Rite-Aid Childrens Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fbe4dfd-1d5d-fc31-e063-6394a90ab3172026-01-14WarningsExact identifier
unii: PDC6A3C0OX
GNP Hemorrhoidal Maximum StrengthHEMORRHOIDALAmerisourcebergen Drug Corporation24103355-cd72-55b0-e063-6394a90a90ec2026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid, Fissure, ProctalgiaSuppositoriesCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1d40d16a-ee52-463a-e063-6394a90a60772026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Anal Care GLO packCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.26612dae-21a0-6f12-e063-6394a90afe932026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid, Fissure, Proctalgia Relief WashCARBON, PANTHENOL, SODIUM HYALURONATEWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1e20de39-45b0-54ec-e063-6294a90a04ed2026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid, Fissure, Proctalgia OintmentsCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL, GLYCERINWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1efe43d5-a29b-5cb2-e063-6394a90aca662026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Childrens Loratadine Sugar FreeLORATADINEWalgreen Company42a73448-104a-4c7f-aea0-cef44d15f5f12026-01-13WarningsExact identifier
application number: ANDA076805
rxcui: 692783
unii: 7AJO3BO7QN
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
unii: PDC6A3C0OX
Sepia Combination 9246SEPIA COMBINATIONProfessional Complementary Health Formulasfe79986b-7b2d-4cfd-8386-45de02115ca92026-01-08WarningsExact identifier
unii: E4GA8884NN
Pancreas DB Liquescence 3037PANCREAS DB LIQUESCENCEProfessional Complementary Health Formulas30bc86e9-538b-449a-af48-99aafc4059242026-01-08WarningsExact identifier
unii: E4GA8884NN
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: 96K6UQ3ZD4
Pineal/Pituitary/Hypothalamus Drops 5022PINEAL/PITUITARY/HYPOTHALAMUS DROPSProfessional Complementary Health Formulas97307e9b-5da3-40d3-a619-0722ca3069802026-01-08WarningsExact identifier
unii: E4GA8884NN
Brain Enhancement Liquescence 3006BRAIN ENHANCEMENT LIQUESCENCEProfessional Complementary Health Formulas33bb2104-c16a-49e4-b292-69e10c1f16c02026-01-08WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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