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 45 of 133 · 2,642 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Deluxe Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC37657895-5fec-82d0-e063-6294a90acf672025-12-15Exact identifier
unii: 15FIX9V2JP
Facial Mineral FusionTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC35944621-e6fb-cd98-e063-6294a90aa6412025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral MousseTITANIUM DIOXIDE, ZINC OXIDECLARITY SKIN CARE STUDIO, INC.35d00778-3857-ce8f-e063-6394a90ab3752025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.35933039-8beb-9f98-e063-6394a90a60bb2025-12-15Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.3592edca-cab0-6c44-e063-6294a90a17272025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38046e71-f171-7e96-e063-6294a90a1f0b2025-12-15Exact identifier
unii: 15FIX9V2JP
Barrier Plus Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38038beb-d0f0-ced2-e063-6294a90ac4232025-12-15Exact identifier
unii: 15FIX9V2JP
Happy Mineral Sunscreen Primer SPFTITANIUM DIOXIDE, ZINC OXIDEACNE CLINIC LAS VEGAS BY JUSTINA37d9c5f2-f414-6efa-e063-6294a90a927f2025-12-15Exact identifier
unii: 15FIX9V2JP
Comfort Mineral Mousse SunscreenTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC3765dd17-ffbd-bcf4-e063-6394a90a2c2b2025-12-15Exact identifier
unii: 15FIX9V2JP
Prime And Protect MatteTITANIUM DIOXIDE, ZINC OXIDEKalon Skin Studio, LLC35939630-1166-1c70-e063-6294a90aac6b2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Lip BalmTITANIUM DIOXIDE, ZINC OXIDEGoldberg, Howard S MD Inc3598205d-2e87-9292-e063-6294a90a1f2a2025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3981c878-826d-f685-e063-6294a90acb242025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984c4b7-94ee-2a8e-e063-6294a90ac24f2025-12-15Exact identifier
unii: 15FIX9V2JP
Ultra Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc833d-f231-5f52-e063-6394a90a37a62025-12-15Exact identifier
unii: 15FIX9V2JP
Ultra Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc4586-5e62-c9e7-e063-6294a90a276b2025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.39821730-f6d1-c01a-e063-6394a90a026b2025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984920a-feb9-169c-e063-6394a90a95682025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdf417-45ba-f81a-e063-6394a90a74712025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd148c-43c7-aa93-e063-6394a90abc8b2025-12-15Exact identifier
unii: 15FIX9V2JP
Sheer Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd62d8-ebe3-b3fd-e063-6394a90a827c2025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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