FDA.reportPublic FDA data

NDC 51672-2085-01 - Childrens Loratadine

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
51672-2085
Requested NDC
51672-2085-01
Package NDCs from labels
51672-2085-8, 51672-2085-4, 51672-2085-5, 51672-2085-1, 51672-2085-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2026-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Children's LoratadineSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2026-07-14HUMAN OTC DRUG LABEL
Childrens Loratadine - Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC2012-09-28HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2085-1Childrens Loratadine1 in 1 CARTONSOLUTION14
51672-2085-1Childrens Loratadine240 mL in 1 BOTTLESOLUTION2404
51672-2085-4Childrens Loratadine1 in 1 CARTONSOLUTION14
51672-2085-4Childrens Loratadine60 mL in 1 BOTTLESOLUTION604
51672-2085-5Childrens Loratadine180 mL in 1 BOTTLESOLUTION1804
51672-2085-5Childrens Loratadine1 in 1 CARTONSOLUTION14
51672-2085-8Childrens Loratadine120 mL in 1 BOTTLESOLUTION1204
51672-2085-8Childrens Loratadine1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2085CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 8 package rows20241222_12c8066a-3429-481e-b63a-7ea2b439a170.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2085-8ML - Milliliter51672-20855184de2c-9fbe-4799-98ab-e9575e71117812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
LoratadineACTIVE MOIETY7AJO3BO7QNCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sucroseINACTIVE INGREDIENTC151H8M554CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
LORATADINEACTIVE INGREDIENT7AJO3BO7QNCHILDRENS LORATADINE (LORATADINE) SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
LORATADINEACTIVE MOIETY7AJO3BO7QNCHILDRENS LORATADINE (LORATADINE) SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCHILDRENS LORATADINE (LORATADINE) SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS LORATADINE (LORATADINE) SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS LORATADINE (LORATADINE) SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS LORATADINE (LORATADINE) SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCHILDRENS LORATADINE (LORATADINE) SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS LORATADINE (LORATADINE) SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS LORATADINE (LORATADINE) SOLUTION [AIDAREX PHARMACEUTICALS LLC]1

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 47 of 52 · 1,025 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine ODTLORATADINEAurohealth LLCa6e04fe7-23d3-47d7-9f18-5c4298fbc28b2022-06-20WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEBluePoint Laboratoriesadc506ed-7a7a-facc-e053-2a95a90ae1472022-06-20WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEAurohealth LLCc6bfb54a-04d8-41c1-9fa9-5d4bae0a66d12022-06-18WarningsExact identifier
unii: 7AJO3BO7QN
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dye-Free Childrens LoratadineLORATADINERITE AID322d9a03-a908-4858-b25e-6eba2411fa032022-06-02WarningsExact identifier
unii: 7AJO3BO7QN
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINE SULFATERite Aidbb0f7653-378f-40b1-8ead-77999fcbd87b2022-05-09WarningsExact identifier
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEAAA PHARMACEUTICAL, INC.9c8535e3-6a60-4640-b37e-a2260936d9af2022-04-21WarningsExact identifier
unii: 7AJO3BO7QN
signature care allergy reliefLORATADINESafeway0a4b8eef-762e-42cc-84ee-0018a9a3be582022-04-04WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINEProficient Rx LPe9b87f79-ebed-4677-8e50-00cb4282ee562022-04-01WarningsExact identifier
unii: 7AJO3BO7QN
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Leader Allergy Relief D-24LORATADINE AND PSEUDOEPHEDRINE SULFATECardinal Healthf1bcd2aa-e8cd-4364-87b4-c544537cdb502022-03-22WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINERising Pharmaceuticals, Incd28128a3-af54-440e-9bd4-0fccf393d18a2022-03-10WarningsExact identifier
unii: 7AJO3BO7QN
topcare childrens allergyLORATADINETopco Associates LLC6e175fae-05dd-45c2-b9ab-7d49369a3c052022-02-28WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
topcare allergy and congestion reliefLORATADINE, PSEUDOEPHEDRINE SULFATETopco Associates LLCdd93d172-2a3a-4e4c-a237-7668acbd537d2022-02-16WarningsExact identifier
unii: 7AJO3BO7QN
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
TH-101CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROBTemple Health Nutrition, LLCd54bb860-560c-4f8f-9aea-a0b7774cc92b2021-12-29WarningsExact identifier
unii: C151H8M554
TreprostinilTREPROSTINILDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LoratadineLORATADINESAFEWAY INC.1092b8af-25f2-4c25-b3bc-5ffb14e960242021-12-21WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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