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 3 of 61 · 1,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
Dye-Free Childrens LoratadineLORATADINECVS PHARMACY, INCaf6e6e60-8e39-45a8-bb76-50403aef96682026-08-04WarningsExact identifier
unii: 7AJO3BO7QN
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PancreaforceLAPPA MAJOR, RHAMNUS PURSHIANA, SYZYGIUM JAMBOLANUM, CHELIDONIUM MAJUS, JUNIPERUS VIRGINIANA, LYCOPODIUM CLAVATUM, MYRTUS COMMUNIS, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, TARENTULA CUBENSISBioActive Nutritional, Inc.0e067fba-762b-4897-8a2b-75d9b77242e32026-07-30WarningsExact identifier
unii: E4GA8884NN
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
allergy reliefLORATADINEWalgreen Company41f8fc1d-2d14-48da-a233-23e9c11296d92026-07-23WarningsExact identifier
unii: 7AJO3BO7QN
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Best Choice Anti Nausea Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDBEST CHOICE (VALU MERCHANDISERS COMPANY)bc8b5208-2dbf-4636-8dd8-68c1ab975f572026-07-17WarningsExact identifier
unii: E4GA8884NN
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Allergy ReliefLORATADINEDr. Reddy's Laboratories Inc.44da36d2-1881-e779-d3a2-13ea828f92402026-07-15WarningsExact identifier
unii: 7AJO3BO7QN
Childrens LoratadineLORATADINESun Pharmaceutical Industries, Inc.12c8066a-3429-481e-b63a-7ea2b439a1702026-07-14WarningsExact identifier
application number: ANDA076805
rxcui: 692783
unii: 7AJO3BO7QN
Childrens Loratadine Sugar FreeLORATADINESun Pharmaceutical Industries, Inc.96a76906-58ad-40cd-be27-4ea254e298c52026-07-14WarningsExact identifier
rxcui: 692783
unii: 7AJO3BO7QN
LoratadineLORATADINENuCare Pharmaceuticals, Inc.569a35be-d653-181c-e063-6294a90a6eb92026-07-14WarningsExact identifier
unii: 7AJO3BO7QN
Good Neighbor Anti Nausea Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDAMERISOURCE BERGEN82488773-3fef-41a0-afa7-e74ea19cd87d2026-07-13WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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