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 50 of 52 · 1,025 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINEAurohealth LLC196da80c-3dbb-40c7-ac93-8a57d6acb1c32020-08-13WarningsExact identifier
unii: 7AJO3BO7QN
careone childrens allergy reliefLORATADINEAmerican Sales Company06d1c443-ec23-4aa1-a7f3-f2b7ffcc25882020-08-10WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATESTRATEGIC SOURCING SERVICES114b5e7c-973a-4a34-8538-a214de090b392020-07-30WarningsExact identifier
unii: 7AJO3BO7QN
Good Neighbor Pharmacy Childrens LoratadineLORATADINEAmerisourceBergen3ffc656a-90f9-4921-9c4f-840023b984332020-06-24WarningsExact identifier
application number: ANDA076805
rxcui: 692783
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEAllegiant Healthf0db3a13-43e6-4243-9a3a-7808ddd005e12020-06-16WarningsExact identifier
unii: 7AJO3BO7QN
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
dg health childrens allergy reliefLORATADINEDolgencorp, LLC302fc570-bec9-43cb-8965-139576102cdd2020-06-10WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEAphena Pharma Solutions - Tennessee, LLC8ffe2faf-3253-4121-a069-6f46e319c6f02020-05-13WarningsExact identifier
unii: 7AJO3BO7QN
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
good sense allergy reliefLORATADINEL. Perrigo Company74bed4ad-5afe-4293-bef3-e0b9d5f64a292019-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEProficient Rx LPca1a6552-d082-4312-ba17-0055e8554eb92019-12-01WarningsExact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINEPUBLIX SUPER MARKETS INC8465d458-b3a7-4ada-a7de-1555942d176b2019-08-07WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEOhm Laboratories Inc.b83de07d-37f4-42b4-b43e-29173454bef02019-07-17WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEKROGER COMPANY6f7f7005-22db-4b88-9771-e31c21e9b2b12019-05-22WarningsExact identifier
unii: 7AJO3BO7QN
CHILDRENS LORATADINELORATADINECVS PHARMACY, INCeca96e9e-7e8f-4e8e-8ec6-43c9fee1096c2019-02-26WarningsExact identifier
unii: 7AJO3BO7QN
Childrens WalitinLORATADINEWalgreen Companyf7962107-f79a-4a04-af8d-f7b989e51f2c2019-01-15WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
LORATADINELORATADINEBionpharma Inc.59bebce3-2b82-4521-a796-2d4c83bcf6692019-01-08WarningsExact identifier
unii: 7AJO3BO7QN
GUNA-ALLERGY-PREVAMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -Guna spaadae93c0-1de9-4e45-ab58-148171f0dc862018-12-21WarningsExact identifier
unii: 2968PHW8QP
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Allergy ReliefLORATADINEAllegiant Health0991388a-2eb8-4913-9efc-adf411eddf3a2018-11-08WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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