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 138 of 189 · 3,774 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IPKN Moist and Firm Beauty Balm LightTITANIUM DIOXIDEInel Cosmetics Co., Ltd.77d77838-aa13-4939-a1a0-50189fbb3fe02024-10-25WarningsExact identifier
unii: 15FIX9V2JP
Premier Value Extra Strength Freshmint FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDECHAIN DRUG CONSORTIUM, LLC1192ebeb-f6cc-45db-8f07-12d36eb55a5f2024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Maximum Strength Assorted FruitCALCIUM CARBONATE, SIMETHICONEPHARMACY VALUE ALLIANCE, LLCe25bf9ca-415b-4a3e-a502-59074308da542024-10-25WarningsExact identifier
unii: H0G9379FGK
PV Extra Strength AntacidCALCIUM CARBONATEPHARMACY VALUE ALLIANCE, LLC8c92de83-ed60-46c3-b289-4b45a1915e242024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Chewable Antacid Ultra Strength Assorted FruitANTACID TABLETSChain Drug Consortium26c742a7-5806-44e0-bef0-c70a9d77dd232024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Consortium, LLC00a58373-77ab-4a46-9862-d179e17c731a2024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Multi Symptom Antacid Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEPharmacy Value Alliance LLC69e0c4a8-04ae-461b-bf47-4180bccd91d62024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Regular Strength Chewable Antacid Peppermint Assorted FruitANTACID TABLETSChain Drug Consortium, LLC245e195f-fd67-497b-83d4-fef75cea8b5b2024-10-25WarningsExact identifier
unii: H0G9379FGK
FATIGUE NOSODE EBASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARANEA DIADEMA, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, SEPIA, EPSTEIN-BARR VIRUS NOSODEEnergique, Inc.36d963cc-fd47-40ee-aa73-c2e7fcedf1922024-10-24WarningsExact identifier
unii: ETJ7Z6XBU4
Complexion HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMEnergique, Inc.ad12d51e-04cb-4833-b802-0038796966ff2024-10-24WarningsExact identifier
unii: ETJ7Z6XBU4
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffbb6af-5a04-f58a-e053-2995a90a1ae22024-10-23WarningsExact identifier
unii: 15FIX9V2JP
Banana BoatTITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands, LLC441a46f0-ecda-4448-e054-00144ff88e882024-10-23WarningsExact identifier
unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28CHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffb8219-7076-de64-e053-2a95a90a60362024-10-23WarningsExact identifier
unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcfee02eb-92f9-be12-e053-2a95a90a43372024-10-23WarningsExact identifier
unii: 15FIX9V2JP
LoratadineLORATADINEAurohealth LLCa057241d-a655-4847-9d2d-d45293f45d872024-10-23WarningsExact identifier
unii: 7AJO3BO7QN
CVS Health 60 Plus Sensitive Skin SunTITANIUM DIOXIDE, ZINC OXIDECVS Pharmacy477c25ec-33db-04a6-e054-00144ff8d46c2024-10-22WarningsExact identifier
unii: 15FIX9V2JP
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.53380470-5748-6fa7-548e-7484ef204c0f2024-10-21WarningsExact identifier
unii: H0G9379FGK
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.8723fe90-8402-4511-b6c6-b71cf98513e32024-10-21WarningsExact identifier
unii: H0G9379FGK
Bali Body Tinted Super Serum Natural SPF 30OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEBali Body Pty Ltdf5eeaf37-33f2-2c0c-e053-2a95a90abcc02024-10-21WarningsExact identifier
unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f42a0b1e-038d-4fab-e053-2995a90a53642024-10-18WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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