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 57 of 61 · 1,201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense allergy reliefLORATADINEL. Perrigo Company3ef968b8-6732-4c80-b385-f471ed4078172021-03-15WarningsExact identifier
unii: 7AJO3BO7QN
signature care allergy and congestion reliefLORATADINE, PSEUDOEPHEDRINE SULFATESafewaye1993d05-248e-48da-838c-068f8263c2eb2021-03-08WarningsExact identifier
unii: 7AJO3BO7QN
DYE-FREE CHILDRENS LORATADINELORATADINEPUBLIX SUPER MARKETS, INC28a0c2b7-f793-43ac-90bc-c155ad141eaf2021-01-21WarningsExact identifier
unii: 7AJO3BO7QN
DYE-FREE CHILDRENS LORATADINELORATADINESAFEWAY7440046f-bf2f-438f-a320-3425d593d1a62021-01-21WarningsExact identifier
unii: 7AJO3BO7QN
CAND-EXLYCOPODIUM,NUX VOMICA,BORAX,ASAFOETIDA,NUX MOSCHATA,GENTIANA LUTEA,KREOSOTUM,CALCAREA CARBONICA,SEPIA,PHOSPHORIC ACID,ECHINACEA,PULSATILLA,BAPTISIA,WHITE MANUFACTURING INC. DBA MICRO WEST4d650a1d-c6b5-410e-9e59-3753a373cc222021-01-21WarningsExact identifier
unii: E4GA8884NN
TOTAL ANDRO BALCHOLESTERINUM, DAMIANA, DNA, HYPOTHALAMUS, LECITHIN, PHOSPHORICUM AC, SABALWhite Manufacturing Inc. DBA Micro-Weste0716657-b579-4183-baf6-8d554f9bf1bb2021-01-21WarningsExact identifier
unii: E4GA8884NN
Yin-Yang BalanceADAMAS, AGARICUS MUSC, AGNUS, ALETRIS, ANGELICA SIN, ARG NIT, ARNICA, AVENA, BARYTA, GRAPHITES, KALI BROM, KREOSOTUM, LYCOPODIUM, OCIMUM SANC, PHOSPHORICUM AC, SELENIUM, SEPIA, THUJA OCC.NET Remediesd132b179-01fd-44b6-b3e2-39ffc6d864852021-01-19WarningsExact identifier
unii: E4GA8884NN
WaterACONITUM NAP, ARSENICUM ALB, BORAX, CALC PHOS, GELSENIUM, LYCOPODIUM, PHOSPHORICUM AC, PICRICUM AC, PLUMB MET, SOLIDAGONET Remedies3dc6fdf6-781c-4dec-9aab-a2237fc60c532021-01-19WarningsExact identifier
unii: E4GA8884NN
FireAPIL MEL, BAPTISIA, BARYTA CARB, HAMAMELIS, KALI BROM, KALI PHOS, LACHESIS, LILIUM, PETROLEUM, PHOSPHORICUM AC, SPIGELIA ANTH, SULPHUR, VERATRUM VIRNET Remedies684d7ff2-b241-4c4e-9a16-14c9adfc260f2021-01-19WarningsExact identifier
unii: E4GA8884NN
LibidoDAMIANA, GALIUM, GLANDULA SUPRARENALIS, HEPAR, HYPOPHYSIS, KOREAN GINSENG, NUPHAR, ORCHITINUM, PHOSPHORICUM AC, POPULUS TREM, TESTOSTERONE.ProBlen74669ed9-05c7-410c-95b4-985b92e000bf2021-01-15WarningsExact identifier
unii: E4GA8884NN
Naturasil Cherry AngiomasPHOSPHORICUM ACIDUMNature's Innovationb512f00e-7b3e-4c7b-a0e6-ebffd84b231f2021-01-14WarningsExact identifier
unii: E4GA8884NN
Naturasil Bite ReliefPHOSPHORICUM ACIDUMNature's Innovation, Inc.4a355788-ea13-4323-a55c-d3b1dab8251e2021-01-14WarningsExact identifier
unii: E4GA8884NN
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Naturasil AcnePHOSPHORIC ACIDNature's Innovation, Inc.586619ab-1dfa-4d5c-b886-fedf5eb4c9da2021-01-14WarningsExact identifier
unii: E4GA8884NN
DYE-FREE CHILDRENS LORATADINELORATADINERITE AIDdce7f475-baa9-4f19-ac49-fb1303786ace2021-01-12WarningsExact identifier
unii: 7AJO3BO7QN
Prime of LifeAGNUS, ALLIUM SATIVUM, AMBRA, ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., AVENA, BAPTISIA, BARYTA CARB., BRYONIA, CANTHARIS, LACHESIS, LYCOPODIUM, NUX VOM., PHOSPHORICUM AC., PULSATILLA, RUTA, SABAL, SELENIUM, ZINC. MET., GINKGONewton Laboratories, Inc.99751ba5-77c2-2e89-e053-2a95a90a12692020-12-07WarningsExact identifier
unii: E4GA8884NN
Hair-ScalpAPIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, THUJA OCC.Newton Laboratories, Inc.9ab3b944-443c-74a1-e053-2a95a90aa0e52020-11-30WarningsExact identifier
unii: E4GA8884NN
DYE-FREE CHILDRENS LORATADINELORATADINEUP & UP9660f7e6-3a29-4a6d-ba57-92088f624aa42020-11-19WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINE 10MGFirst Aid Direct3a580dc7-ff09-462c-9b18-2051053490352020-11-12WarningsExact identifier
unii: 7AJO3BO7QN
allergy relief dLORATADINE, PSEUDOEPHEDRINE SULFATEPublix Super Markets Inc8209d7d5-4ecc-4170-ba50-5917bd8c46d42020-10-19WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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