FDA.reportPublic FDA data

NDC 70677-1058-01 - 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
70677-1058
Requested NDC
70677-1058-01
Package NDCs from labels
70677-1058-1, 70677-1058-01
Manufacturer
STRATEGIC SOURCING SERVICES LLC | Sun Pharma Canada Inc.
Effective date
2025-07-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loratadine Oral SolutionSTRATEGIC SOURCING SERVICES LLC | Sun Pharma Canada Inc.2025-07-30HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70677-1058-12025-07-30C16284748780-13b156c62-27ac-fb37-e063-e6dba90a4e07Loratadine Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1058-1Childrens Loratadine Sugar Free1 in 1 CARTONSOLUTION12
70677-1058-1Childrens Loratadine Sugar Free120 mL in 1 BOTTLESOLUTION1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1058CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 2 package rows20230805_809456dc-1d1c-42a7-b17f-e43dacde927f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1058-1ML - Milliliter70677-1058ea3f1023-07bb-4f55-994f-21d9e0aa229f12024-01-04

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 8 of 61 · 1,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
unii: PDC6A3C0OX
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
LoratadineLORATADINECamber Consumer Care Inc4dec6d48-78e0-48a4-9274-25f6cbf26a2c2026-04-10WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
unii: PDC6A3C0OX
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
unii: PDC6A3C0OX
allergy relief d 12LORATADINE, PSEUDOEPHEDRINE SULFATEWalgreen Company7e6ea563-cc79-4683-b600-0691e0fb78ab2026-04-09WarningsExact identifier
unii: 7AJO3BO7QN
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Childrens LoratadineLORATADINESun Pharmaceutical Industries, Inc.78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d02026-04-08WarningsExact identifier
application number: ANDA076805
rxcui: 692783
unii: 7AJO3BO7QN
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
unii: PDC6A3C0OX
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: E4GA8884NN
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: E4GA8884NN
LoratadineLORATADINENuCare Pharmaceuticals,Inc.16f00a3a-0777-f70c-e063-6294a90a71c92026-04-06WarningsExact identifier
unii: 7AJO3BO7QN
PancreaplexCHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, NUX MOSCHATA, RHEUM (PALMATUM), SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, ZINGIBER OFFICINALE, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOPHYSIS SUIS, PANCREAS SUIS, THYROIDINUM (SUIS), PHASEOLUS, PHOSPHORICUM ACIDUM, PHOSPHORUSBioActive Nutritional, Inc.4f7fbb76-79c0-4c1e-aa30-a39492db63d82026-04-03WarningsExact identifier
unii: E4GA8884NN
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
DNA Pancreas FormulaLYCOPODIUM CLAVATUM, PANCREAS SUIS, DNA, INSULINUM (HUMAN), PHOSPHORICUM ACIDUM, RADIUM BROMATUM, URANIUM NITRICUMNutritional Specialties, Inc.004b278d-b129-416f-a8d4-1acad71338cf2026-04-02WarningsExact identifier
unii: E4GA8884NN
DNA Pancreas FormulaLYCOPODIUM CLAVATUM, PANCREAS SUIS, DNA, INSULINUM, PHOSPHORICUM ACIDUM, RADIUM BROMATUM, URANIUM NITRICUMNutritional Specialties, Inc.dc0ddf27-5c97-4ec4-9032-ecaff0c8f5712026-04-02WarningsExact identifier
unii: E4GA8884NN
ALLERGY RELIEF 10 mgLORATADINETWIN MED LLCd943f548-aa0d-4476-e053-2a95a90a7bd42026-04-01WarningsExact identifier
unii: 7AJO3BO7QN
ALLERGY RELIEFLORATADINECARDINAL HEALTH 110, LLC. DBA LEADER052e0ea2-441f-42cc-b62c-f2574f995bff2026-03-31WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINESafecor Health, LLC14d1ecf5-d694-4ce0-87e4-df27f3f4d9092026-03-31WarningsExact identifier
unii: 7AJO3BO7QN
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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