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 55 of 61 · 1,201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: E4GA8884NN
Acne ReliefANTIMONIUM CRUD, ARSENICUM BROM, BOVISTA, EUGENIA JAMB, FLUORICUM ACIDUM, HEPAR SULPH CALC, KALI BROM, KALI IOD, KALI MUR, NAT BROM, NICCOLUM SULPH, PHOSPHORICUM AC, SULPHUR IOD.OHM PHARMA INC.8ecc9282-3aa4-47f1-a928-89280b2cd8062021-12-29WarningsExact identifier
unii: E4GA8884NN
Damiana ComplexAGNES CASTUS, AVENA SATIVA, DAMIANA, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, LYCOPODIUM CLAVATUM, ORCHITINUM, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SELENIUM METALLICUM.OHM PHARMA INC.e1bf2bd7-dddf-40e2-bfe2-b907af36996a2021-12-29WarningsExact identifier
unii: E4GA8884NN
OHM Fatigue ReliefACETICUM AC, ADRENAL GLAND, ARNICA, BENZOICUM AC, FERRUM PHOS, FLUORICUM AC, GINSENG, KALI CARB, KALI LOD, KALI MUR, KALI PHOS, LACTICUM AC, PHOSPHORICUM AC, PICRICUM AC.OHM PHARMA INC.419c6315-37de-46b4-8bef-abbeace265b62021-12-29WarningsExact identifier
unii: E4GA8884NN
OHM Pancreas AidHELONIAS DIOICA, LACTICUM ACIDUM, PANCREAS SUIS, PANCREATINUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM, THYROIDINUM, URANIUM NITRICUM.OHM PHARMA INC.0a38d0eb-aa56-4dd1-a443-8d5d44744bf62021-12-29WarningsExact identifier
unii: E4GA8884NN
OHM Tonic SyrupALFALFA, ARALIA QUIN (GINSENG), AVENA, CALC PHOS, CINCHONA, FERRUM PHOS, HYDRASTIS, KALI IOD, KALI MUR, KALI PHOS, MAG PHOS, NAT PHOS, NUX VOM, PHOSPHORICUM AC.OHM PHARMA INC.f3aca2b2-8df2-4995-91fd-c81c3286a0f82021-12-29WarningsExact identifier
unii: E4GA8884NN
Sterile Diluent for TreprostinilWATERDr.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
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATESafeway Inc.c1e1e0ca-30df-4ace-a7b6-c66a3c5ab6762021-12-21WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINECVS Pharmacye63f082c-ff50-43ed-ad2c-598b352413e82021-12-21WarningsExact identifier
unii: 7AJO3BO7QN
Alavert Allergy and Congestion D-12 hourLORATADINE AND PSEUDOEPHEDRINE SULFATEFoundation Consumer Brands1a669f3c-36a6-439e-843d-47638fa217e82021-12-07WarningsExact identifier
unii: 7AJO3BO7QN
Topcare Allergy ReliefLORATADINETopco Associates LLC32f4e1d1-c830-4752-8251-bcc233bf03f62021-11-29WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEMARKSANS PHARMA LIMITEDc30907f9-1761-41e5-bd4e-2613e756e1c62021-11-15WarningsExact identifier
unii: 7AJO3BO7QN
careone allergy reliefLORATADINEAmerican Sales Companyfdacfd88-eb85-4a33-9863-c6ff484fea4e2021-11-15WarningsExact identifier
unii: 7AJO3BO7QN
PASSIFLORA PLEXPASSIFLORA INCARNATA, IGNATIA AMARA, JALAPA, COFFEA CRUDA, MAGNESIUM METALICUM, PALLADIUM METALLICUM, TELLURIUM METALLICUM, PHOSPHORICUM ACIDUMSanUp937b6700-3ba8-0266-e053-2995a90a33182021-11-10WarningsExact identifier
unii: E4GA8884NN
Adrenal and DHEAARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA.ProBLEN44991952-c440-4a33-9423-a9369c8bab702021-10-22WarningsExact identifier
unii: E4GA8884NN
PHOSPHORICUM ACIDUMPHOSPHORICUM ACIDUMRxhomeo Private Limited d.b.a. Rxhomeo, Incb9fa6434-1d71-4d40-b275-b5b2fbb126c12021-09-27WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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