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 83 of 130 · 2,594 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDf106f52b-2157-46c7-9f7c-50f43a6490502025-01-09WarningsExact identifier
unii: 15FIX9V2JP
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEETHEREAL AESTHETICS LLC065d17cf-bea5-137f-e063-6394a90aeeb32025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESERRAO, E JOHN MD FACOGfea61544-6684-ad34-e053-6294a90a48f32025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENew Beginnings Tattoo Removalfea87de3-116f-4774-e053-6394a90a0aad2025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPURA VIDA BODY & MIND SPA, INC.04b38e97-c4b3-df23-e063-6394a90ae6b72025-01-08WarningsExact identifier
unii: 15FIX9V2JP
EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPremier Plastic Surgerybc9221fe-89b4-4ad8-e053-2995a90aa0412025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEEmerald Aesthetics LLCf80f439d-f4f0-fbf3-e053-6294a90ae0ef2025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESuzanne's Skin2soul LLCfea667a1-6bec-9819-e053-6394a90a9b962025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBEAUTY SENSE MEDSPA INCfe93a337-8d2f-35d3-e053-6294a90acb3c2025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen Emulsion SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co.1d560670-026b-bd34-e063-6394a90a9af42025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: ETJ7Z6XBU4
sunbetter Broad Spectrum SPF 56 Sunscreen Stick SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC92c4e4cb-aadc-26f4-e053-2995a90a03d52025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 56 Sunscreen Compact SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb8a4986d-c28f-c4f4-e053-2a95a90a71672025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC8f119447-045b-43f3-e053-2995a90aea772025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 75 Sunscreen Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb878ee3b-6897-3c4a-e053-2995a90afed72025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 70 Sunscreen SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb879067b-9d7f-3a62-e053-2995a90a9d6b2025-01-06WarningsExact identifier
unii: 15FIX9V2JP
glo SKIN BEAUTY Luminous Liquid Foundation SPF 18GLO SKIN BEAUTY LUMINOUS LIQUID FOUNDATION SPF 18Hayden Caleel LLCdd863361-281d-45fe-a8c1-6e4c670809a52025-01-05WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jucre Rebirth BBTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, NIACINAMIDE, ADENOSINENATURECELL CO., LTD.2ab403df-29b3-75af-e063-6394a90a6ca42025-01-02WarningsExact identifier
unii: 15FIX9V2JP
Green Defense Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEFarmacy Beauty LLCadf0f50f-6357-bc1f-e053-2a95a90ad9972025-01-02WarningsExact identifier
unii: 15FIX9V2JP
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c0ff5df4-0b37-0b1b-e053-2a95a90a862c2025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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