FDA.reportPublic FDA data

NDC 62011-0071-01 - Loratadine and Pseudoephedrine Sulfate

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
62011-0071
Requested NDC
62011-0071-01
Package NDCs from labels
62011-0071-2, 62011-0071-1, 62011-0071-01
Manufacturer
Strategic Sourcing Services LLC | Sun Pharmaceutical Industries Inc. | Ohm Laboratories Inc.
Effective date
2024-11-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsStrategic Sourcing Services LLC | Sun Pharmaceutical Industries Inc. | Ohm Laboratories Inc.2024-11-22HUMAN OTC DRUG LABEL
Drug FactsStrategic Sourcing Services LLC | Sun Pharmaceutical Industries Inc. | Ohm Laboratories Inc.2024-11-21HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0071-1Loratadine and Pseudoephedrine Sulfate10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE105
62011-0071-2Loratadine and Pseudoephedrine Sulfate15 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0071LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]5Current NDC, Legacy NDC, 1 package rows20241123_48bfc938-d97d-4b49-8637-3b00ac870902.zip
62011-0071LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]5Current NDC, Legacy NDC, 1 package rows20241123_cdecad62-bf1e-43fb-b4be-8fc54b63e4ae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0071-1EA - Each62011-0071cf52c418-ca82-42f1-b496-6f064a51b45812013-02-13
62011-0071-2EA - Each62011-00711e1c366c-ae3e-4271-a99e-69ba07bbf21012018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
PSEUDOEPHEDRINE SULFATEACTIVE INGREDIENTY9DL7QPE6BLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
SHELLACINACTIVE INGREDIENT46N107B71OLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]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 129 of 190 · 3,788 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolf22626c1-0996-41d8-a2ec-3bf7491df6572024-12-18WarningsExact identifier
unii: 15FIX9V2JP
Guardian Extra Strength AntacidCALCIUM CARBONATEGuardian Drug Companyaef3d830-c5c3-4f72-86ba-d31945a756db2024-12-18WarningsExact identifier
unii: H0G9379FGK
SPF 50 plus Sunscreen All Mineral Active IngredientsTITANIUM DIOXIDE AND ZINC OXIDEKAS Direct LLC dba BabyGanics247aae3d-1845-4dd8-b774-b9e8214809a22024-12-18WarningsExact identifier
unii: 15FIX9V2JP
STUDIO FIX FLUID BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEMAKEUP ART COSMETICSfb59afc1-1dc9-f783-e053-6394a90a196b2024-12-17WarningsExact identifier
unii: 15FIX9V2JP
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREENOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEMAKEUP ART COSMETICSe5fd3e40-de1d-4cdd-b725-4a517514ca352024-12-17WarningsExact identifier
unii: 15FIX9V2JP
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35OCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICS2d034810-7210-4ad4-be23-ec2100f8c2f12024-12-17WarningsExact identifier
unii: 15FIX9V2JP
Tums Chewy BitesCALCIUM CARBONATENavajo Manufacturing Company Inc.297d6703-ed4e-10d3-e063-6394a90a9f3a2024-12-17WarningsExact identifier
unii: H0G9379FGK
Cerave Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Deep Sheer TintTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inca1cab79d-0151-49ee-86dc-c2739842e62e2024-12-17WarningsExact identifier
unii: 15FIX9V2JP
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)RUGBY LABORATORIESf21c8cf7-45cb-492b-bf4a-462024a545692024-12-17WarningsExact identifier
unii: H0G9379FGK
SPF 50 plus SunscreenTITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDEKAS Direct LLC dba BabyGanics5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b2024-12-17WarningsExact identifier
unii: 15FIX9V2JP
Even Up Sunscreen SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef9d375af-3c8b-4462-b729-fdd4be9292842024-12-17WarningsExact identifier
unii: 15FIX9V2JP
Extra Strength Antacid Tablets, Caseys 4goodCALCIUM CARBONATE 750 MGLil' Drug Store Prodsucts, Inc.026aefd6-bb80-1ffd-e063-6394a90a12622024-12-16WarningsExact identifier
unii: H0G9379FGK
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEBobbi Brown Professional Cosmetics Inc.dc6b28ca-b922-460a-8028-fb3f5afdbe9d2024-12-16WarningsExact identifier
unii: 15FIX9V2JP
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDEBobbi Brown Professional Cosmetics Inc.1f9a4b71-45aa-4156-9fe6-ffa81f808a852024-12-16WarningsExact identifier
unii: 15FIX9V2JP
Natural Finish Pressed Foundation SPF 20 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColoresciencec389e183-bfad-4813-af09-fae3aa05e82a2024-12-16WarningsExact identifier
unii: 15FIX9V2JP
Sunforgettable Total Protection Brush-On Shield SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColoresciencec77357f1-7ada-4325-86f7-5ee801610f422024-12-16WarningsExact identifier
unii: 15FIX9V2JP
WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEBobbi Brown Professional Cosmetics Inc.fbd04b66-738b-2762-e053-6394a90a8b722024-12-13WarningsExact identifier
unii: 15FIX9V2JP
LoratadineLORATADINESpirit Pharmaceuticals LLCaf0cdab2-27a4-5f30-e053-2a95a90a5e712024-12-13WarningsExact identifier
unii: 7AJO3BO7QN
Calming Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienced681cdb5-307e-4a2a-8e1d-2b29131d48d02024-12-13WarningsExact identifier
unii: 15FIX9V2JP
Foster and Thrive Regular Strength AntacidCALCIUM CARBONATEStrategic Sourcing Services LLC1aeb60fb-eebe-4e54-be1c-4e01f3b7269c2024-12-13WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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