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 50 of 61 · 1,201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-Drowsy Allergy ReliefLORATADINE TABLETLil' Drug Store Products, Inc.031fc3e5-b5eb-447c-e063-6294a90a13b52023-08-17WarningsExact identifier
unii: 7AJO3BO7QN
Equaline Childrens Allergy ReliefLORATADINEUnited Natural Foods, Inc. dba UNFI25329c7d-76e7-47b3-914e-ac367bbb750b2023-08-17WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINESTRATEGIC SOURCING SERVICES LLC07f03186-438d-41b7-a871-f05a387333292023-08-11WarningsExact identifier
unii: 7AJO3BO7QN
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 6DC9Q167V3
AnpituaparHYPOPHYSIS SUIS, AGNUS CASTUS, BARYTA CARBONICA, CALCAREA CARBONICA, IODIUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SEPIA, THYROIDINUM (SUIS), LAC CANINUM, ADRENOCORTICOTROPHINEnergique, Inc.c0ed2996-8eb5-43f7-b3cc-17477af7f7e92023-07-13WarningsExact identifier
unii: E4GA8884NN
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 6DC9Q167V3
unii: E4GA8884NN
Loratadine ODTLORATADINEAmerisource Bergend2524455-b6c4-442b-b139-666a555c52982023-07-10WarningsExact identifier
unii: 7AJO3BO7QN
kirkland signature allerclear d 12 hrLORATADINE, PSEUDOEPHEDRINE SULFATECostco Wholesale Company1534720b-f8f8-4db5-99e0-cfa49acf92992023-07-07WarningsExact identifier
unii: 7AJO3BO7QN
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALS, INC3529be10-0004-4628-9ca1-67a8acd86b512023-07-05Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
LORATADINELORATADINEDr. Reddy's Laboratories Inc.d707733d-1ee9-92d3-f5b2-3567b9c217c22023-06-25WarningsExact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINEDr. Reddy's Laboratories Inc.bb6af6a4-aec0-ddf5-57b7-063504ca8e1e2023-06-25WarningsExact identifier
unii: 7AJO3BO7QN
topcare childrens allergy reliefLORATADINETopco Associates LLC4f7555ea-6286-4ff6-b125-d12660ae4bdf2023-06-20WarningsExact identifier
unii: 7AJO3BO7QN
Vital Skin Hair NailsL-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.3e8a9233-6e65-4023-b3f8-8bca369a9c2a2023-06-15WarningsExact identifier
unii: E4GA8884NN
PeacefuliAVENA SATIVA, HUMULUS LUPULUS, PASSIFLORA INCARNATA, KALI PHOSPHORICUM, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, IGNATIA AMARARatis, LLCeb3bc662-3d3d-4e4d-8561-330ad0eb08f22023-05-25WarningsExact identifier
unii: E4GA8884NN
Acidum PhosphoricumACIDUM PHOSPHORICUMHahnemann Laboratories, INC.fc6595b6-003b-65b5-e053-6394a90acb5a2023-05-23Exact identifier
unii: E4GA8884NN
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Phosphoricum acidumPHOSPHORIC ACIDBoiron86931345-adca-144a-e053-2a91aa0ad09c2023-05-16Exact identifier
unii: E4GA8884NN
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LoratadineLORATADINEPLD Acquisitions LLC DBA Avma Pharma Solutions2edb53f8-7661-4e54-bb50-e03078bae3bf2023-05-04WarningsExact identifier
unii: 7AJO3BO7QN
Diathesis IVGINKGO BILOBA, FEL TAURI, KIDNEY (SUIS), GERMANIUM SESQUIOXIDE, ARGENTUM METALLICUM, CUPRUM METALLICUM, CYSTEINUM, AURUM METALLICUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, FUMARICUM ACIDUM, MERCURIUS SOLUBILIS, NATRUM OXALACETICUM, NUX VOMICA, PHOSPHORICUM ACIDUMBioActive Nutritional, Inc.74b5157f-c33f-494a-ab61-0e0a547b5f4a2023-04-13WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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