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 116 of 191 · 3,811 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Peppermint AntacidCALCIUM CARBONATEDeMoulas Market Basket89bdb1c0-df39-4c37-bb0d-0bfd0bff85fb2025-02-07WarningsExact identifier
unii: H0G9379FGK
Ultra Strength AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1cbea7c2-fdc0-5a6b-e063-6294a90a9cfa2025-02-07WarningsExact identifier
unii: H0G9379FGK
Regular Strength AntacidCALCIUM CARBONATEDeMoulas Market Basketbe167e45-3db8-4739-91ac-e83d552236172025-02-07WarningsExact identifier
unii: H0G9379FGK
Extra Strength Smooth AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1b6a4808-4d0b-783c-e063-6394a90af0c32025-02-07WarningsExact identifier
unii: H0G9379FGK
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.9bb84bae-9019-ed76-e053-2a95a90a5c3e2025-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba993f4-97af-4119-e053-2995a90a126d2025-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
Ear Wax Build-UpELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATANewton Laboratories, Inc.9302b838-6003-ba6a-e053-2995a90aedd32025-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENTZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cfe6a6-c2e4-8fb8-e063-6294a90adc782025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a8bab8-ca5d-6b65-e063-6294a90abb072025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a82029-bdb1-cbe0-e063-6294a90a08f32025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a87c6b-3c7d-5942-e063-6294a90aa4522025-02-06WarningsExact identifier
unii: 15FIX9V2JP
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.02a671ed-485d-d6b7-e063-6394a90ad4af2025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Cicapair Tiger Grass Camo DropsZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cf0522-a3c1-aea8-e063-6294a90aabfe2025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Ultra Strength Antacid Assorted BerriesCALCIUM CARBONATEGuardian Drug Company7f0ca229-7452-4f18-bd2f-bf2dfc3482f82025-02-06WarningsExact identifier
unii: H0G9379FGK
Alkums antacidCALCIUM CARBONATEGuardian Drug Company7451cd9f-1723-46d0-837e-8dc48bfb6bba2025-02-06WarningsExact identifier
unii: H0G9379FGK
Loratadine antihistamineLORATADINENuCare Pharmaceuticals,Inc.fc63689e-e449-ca8f-e053-6394a90a54a22025-02-05WarningsExact identifier
unii: 7AJO3BO7QN
PRIDICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.d22eca2f-d7e6-3412-e053-2995a90a63842025-02-05WarningsExact identifier
unii: ETJ7Z6XBU4
Extra Strength AntacidCALCIUM CARBONATERetail Business Services, LLC.1e97c054-d6b3-425a-e063-6394a90af8362025-02-04WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATERetail Business Services, LLC.214eed56-2d35-8a69-e063-6394a90a15432025-02-04WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEHarris Teeter, LLC2bda25ff-9e56-8f8d-e063-6294a90a6a0f2025-02-04WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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