FDA.reportPublic FDA data

NDC 0245-0575-89 - Isotretinoin

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
0245-0575
Requested NDC
0245-0575-89
Package NDCs from labels
0245-0575-89, 0245-0575-01
Manufacturer
Upsher-Smith Laboratories, LLC
Effective date
2022-10-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isotretinoin - Upsher-Smith Laboratories, LLCUpsher-Smith Laboratories, LLC2022-10-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0245-0575-01Isotretinoin3 in 1 BOXCAPSULE, LIQUID FILLED35
0245-0575-89Isotretinoin10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0575ISOTRETINOIN CAPSULE, LIQUID FILLED [UPSHER-SMITH LABORATORIES, LLC]5Current NDC, Legacy NDC, 2 package rows20221029_ff1edbb8-ac0e-4563-9c2a-94385ce055e3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0575-01EA - Each0245-057589540afb-68bc-474b-9371-4aab3a9fd7cf12021-07-15
0245-0575-89EA - Each0245-0575df7e409f-9457-4934-8785-dd481a962cee12021-07-15

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 59 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Svens Everyday Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESvens, Inc912170ae-124c-5eb9-e053-2995a90a0ba32025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Wander Beauty Pack Up and Glow PrimingTITANIUM DIOXIDE, ZINC OXIDEWander Beauty3d844efc-091c-9a9b-e063-6294a90aee7c2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc372894af-bed7-474f-95d4-69a8c3f215ef2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Glo SkinTITANIUM DIOXIDE, ZINC OXIDEGlo Skin Beautyf4bed574-68c1-0d2c-e053-2a95a90a15ff2025-11-13WarningsExact identifier
unii: 15FIX9V2JP
Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTEDTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.279a5214-79b2-44e9-b003-378d0b9923952025-11-11WarningsExact identifier
unii: 15FIX9V2JP
buttah Tinted Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEButtah Enterprises, LLC.43458152-0775-dd9c-e063-6394a90a61402025-11-10WarningsExact identifier
unii: 15FIX9V2JP
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
unii: 1K09F3G675
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 1K09F3G675
Walgreens SPF 50 Tinted Mineral FluidTITANIUM DIOXIDEWalgreens345918e3-95f8-404c-e063-6394a90a3fca2025-11-09WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 500 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.d690d5d1-e1fa-404f-a17e-7b97be17b44a2025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 510 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.2fbdeff7-4880-49ef-bb4d-e033d18e04592025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.6a86e5fd-6736-45e0-aa7d-d268fdaed4f82025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.42a3625f-5c58-4ec5-895f-b14f744282712025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8e14fe81-cf7f-4a81-afec-e6c8466179c92025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.7dd9f4cb-78d8-4edc-a63c-d4a02930a0f82025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8acb660f-94bd-4c4f-b0c1-3682cf8ed5432025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC SPF 30 Fair 150 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.fad2bec7-c5f4-45f4-aff4-a5022033cb6a2025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC SPF 30 Medium 355 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.39856c69-84fb-4b12-a713-8912263e42b12025-11-07WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCeeb3c173-b280-76e4-e053-2995a90a0e792025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCefcd52c2-4208-46a1-e053-2a95a90a857d2025-11-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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