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 8 of 61 · 1,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
unii: PDC6A3C0OX
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
LoratadineLORATADINECamber Consumer Care Inc4dec6d48-78e0-48a4-9274-25f6cbf26a2c2026-04-10WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
unii: PDC6A3C0OX
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
unii: PDC6A3C0OX
allergy relief d 12LORATADINE, PSEUDOEPHEDRINE SULFATEWalgreen Company7e6ea563-cc79-4683-b600-0691e0fb78ab2026-04-09WarningsExact identifier
unii: 7AJO3BO7QN
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Childrens LoratadineLORATADINESun Pharmaceutical Industries, Inc.78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d02026-04-08WarningsExact identifier
application number: ANDA076805
rxcui: 692783
unii: 7AJO3BO7QN
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
unii: PDC6A3C0OX
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: E4GA8884NN
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: E4GA8884NN
LoratadineLORATADINENuCare Pharmaceuticals,Inc.16f00a3a-0777-f70c-e063-6294a90a71c92026-04-06WarningsExact identifier
unii: 7AJO3BO7QN
PancreaplexCHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, NUX MOSCHATA, RHEUM (PALMATUM), SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, ZINGIBER OFFICINALE, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOPHYSIS SUIS, PANCREAS SUIS, THYROIDINUM (SUIS), PHASEOLUS, PHOSPHORICUM ACIDUM, PHOSPHORUSBioActive Nutritional, Inc.4f7fbb76-79c0-4c1e-aa30-a39492db63d82026-04-03WarningsExact identifier
unii: E4GA8884NN
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
DNA Pancreas FormulaLYCOPODIUM CLAVATUM, PANCREAS SUIS, DNA, INSULINUM (HUMAN), PHOSPHORICUM ACIDUM, RADIUM BROMATUM, URANIUM NITRICUMNutritional Specialties, Inc.004b278d-b129-416f-a8d4-1acad71338cf2026-04-02WarningsExact identifier
unii: E4GA8884NN
DNA Pancreas FormulaLYCOPODIUM CLAVATUM, PANCREAS SUIS, DNA, INSULINUM, PHOSPHORICUM ACIDUM, RADIUM BROMATUM, URANIUM NITRICUMNutritional Specialties, Inc.dc0ddf27-5c97-4ec4-9032-ecaff0c8f5712026-04-02WarningsExact identifier
unii: E4GA8884NN
ALLERGY RELIEF 10 mgLORATADINETWIN MED LLCd943f548-aa0d-4476-e053-2a95a90a7bd42026-04-01WarningsExact identifier
unii: 7AJO3BO7QN
ALLERGY RELIEFLORATADINECARDINAL HEALTH 110, LLC. DBA LEADER052e0ea2-441f-42cc-b62c-f2574f995bff2026-03-31WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINESafecor Health, LLC14d1ecf5-d694-4ce0-87e4-df27f3f4d9092026-03-31WarningsExact identifier
unii: 7AJO3BO7QN
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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