FDA.reportPublic FDA data

NDC 10337-001 - Flora Q2

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
10337-001
Package NDCs from labels
10337-001-30
Manufacturer
PharmaDerm A division of Fougera Pharmaceuticals Inc.
Effective date
2012-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Flora Q2 - PharmaDerm A division of Fougera Pharmaceuticals Inc.PharmaDerm A division of Fougera Pharmaceuticals Inc.2012-05-07DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10337-001-30Flora Q230 in 1 BOTTLECAPSULE301
10337-001-30Flora Q21 in 1 CARTONCAPSULE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10337-001FLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]12 package rows20120508_5ef6a80c-4787-4ef0-8b8d-2a2c3ff60249.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10337-001-30EA - Each10337-001dccbd682-3618-4ffd-b7fb-7feecb2b327e12013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lactobacillus acidophilusACTIVE INGREDIENT1PRR1V42V5FLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
lactobacillus acidophilusACTIVE MOIETY1PRR1V42V5FLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOFLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30FLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DFLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4FLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
sodium alginateINACTIVE INGREDIENTC269C4G2ZQFLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]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 108 of 130 · 2,594 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inceb43177e-389d-4572-8521-ee4d0a2dad3a2023-12-30WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC34f0c2c9-a5bc-4b25-bfc1-336dcbb353e42023-12-30WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Infallible Up to 24 H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc917f6775-8f48-4b7e-9f67-253bc0c6d59e2023-12-29WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Visible lift Serum Absolute Advanced Age Reversing Makeup Broad Spectrum SPF 17OCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inca31dacaa-738d-4da8-95b2-4d737c5266832023-12-29WarningsExact identifier
unii: 15FIX9V2JP
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.22c8f143-1c23-4a10-9577-2adc03f1b6b22023-12-28WarningsExact identifier
unii: ETJ7Z6XBU4
Dermablend Professional Smooth Camo Medium Coverage Foundation Broad Spectrum SPF 25 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incaec1957a-f68d-4fbd-af9e-f8b257daea462023-12-27WarningsExact identifier
unii: 15FIX9V2JP
Equate Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Wal-Mart Stores, Inc.91fb8fb5-b871-4535-e053-2995a90a9b162023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Sunmark Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC043ccc34-44ee-416a-88bc-f247774e90752023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Rite Aid Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Rite Aid Corporationfa1b5b66-9643-e9a7-e053-6394a90ae3cf2023-12-23WarningsExact identifier
unii: 3NXW29V3WO
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen fairTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.32569352-c51e-4f05-a8b0-749ef916a5af2023-12-22WarningsExact identifier
unii: 15FIX9V2JP
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
unii: 3NXW29V3WO
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc0adb52f5-4e1f-4570-9b6f-584e4da61d9f2023-12-22WarningsExact identifier
unii: 15FIX9V2JP
ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCc670635a-63d8-4b0b-afd7-b26e969f93a12023-12-21WarningsExact identifier
unii: 15FIX9V2JP
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 16N fair-light neutralTITANIUM DIOXIDETarte, Inc.62fffef6-29ae-4137-b0b9-fb93d61679332023-12-21WarningsExact identifier
unii: 15FIX9V2JP
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 12N fair neutralTITANIUM DIOXIDETarte, Inc.889860fc-7fce-47e9-af28-a3b2aec04a0e2023-12-21WarningsExact identifier
unii: 15FIX9V2JP
Walgreens Multi-Symptom Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEWalgreen Co.a03789ce-66bd-7b12-e053-2995a90af85a2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
Walgreens Lubricant Eye Drops Preservative FreeDEXTRAN 70, HYPROMELLOSEWalgreen Company9b383e41-e116-1c12-e053-2a95a90ab25f2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
Coola Bare Republic Mineral Face-Lotion SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%COOLA LLCa334a61d-5c5a-4f45-b202-6dd7bb3d250b2023-12-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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