FDA.reportPublic FDA data

NDC 0832-8301-89 - 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
0832-8301
Requested NDC
0832-8301-89
Package NDCs from labels
0832-8301-89, 0832-8301-30
Manufacturer
Upsher-Smith Laboratories, LLC | Douglas Manufacturing Limited
Effective date
2026-02-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isotretinoin - Upsher-Smith Laboratories, LLC | Douglas Manufacturing LimitedUpsher-Smith Laboratories, LLC | Douglas Manufacturing Limited2026-02-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-8301-30Isotretinoin3 in 1 BOXCAPSULE, LIQUID FILLED33
0832-8301-89Isotretinoin10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-8301ISOTRETINOIN CAPSULE, LIQUID FILLED [UPSHER-SMITH LABORATORIES, LLC]1Current NDC, 2 package rows20230610_c369e1c3-90c5-4768-9741-56c62253a2c4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-8301-30EA - Each0832-83016c5461fa-765c-4e1a-8c78-4f4e8c8cdc2712023-07-06
0832-8301-89EA - Each0832-830124b5cfbe-3da0-4e76-a642-75425637d88312023-08-08

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 155 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care SQUISHMALLOWS SWEET PEA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.1bf02dec-ecea-4bbd-94e2-cfafbc43e8852025-10-16WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION PURE FRESHNESS HAND SANITIZER HIBISCUS SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO4799a403-dfcb-4324-8ac9-ac56a99097cf2025-10-16WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION HAND SANITIZER AMBER AND LAVENDER SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOc0edb6a8-8687-48a5-81d8-2a97d79502d82025-10-16WarningsExact identifier
unii: 3K9958V90M
SOFT TOUCH HAND SANITIZER PEONY BLUSH SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2d7dfba8-8607-4e4e-adf3-8cdbee0d10342025-10-16WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.412e961a-b7d4-b1c2-e063-6294a90a6b852025-10-15WarningsExact identifier
unii: 3K9958V90M
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
SEDLAVISOPROPYL ALCOHOLInstock Distributing1b31e3dc-31f3-dffe-e063-6394a90a1c962025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c470960-f78d-19e7-e063-6294a90a49202025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c477028-5cee-b8e2-e063-6394a90afb772025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c472c35-e241-773f-e063-6294a90abb572025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOL WIPESInstock Distributing1c478594-3118-048f-e063-6394a90a35d92025-10-15WarningsExact identifier
unii: ND2M416302
BCBGENERATION HAND SANITIZER COCONUT WATER SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOe96b8df6-0b8b-4b2a-806d-f65b85191fc62025-10-15WarningsExact identifier
unii: 3K9958V90M
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
unii: PDC6A3C0OX
Smart Care Barbie SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.0d6a56a0-f678-4e23-ac66-aab35c55fbf32025-10-14WarningsExact identifier
unii: 3K9958V90M
Alcohol wipes Hand Sanitizing WipesALCOHOLDGE Essentials Incd14bf315-b0fa-4d3c-9801-e28678818af92025-10-14WarningsExact identifier
unii: 3K9958V90M
Smart Care Crayola ROYAL PURPLE SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.4246fbcf-7210-4767-b84b-b7b15ae767952025-10-13WarningsExact identifier
unii: 3K9958V90M
Smart Care Peppa Pig SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.b0e514f4-5342-4e67-9410-c3d6ce9dc9f62025-10-13WarningsExact identifier
unii: 3K9958V90M
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
BCBGENERATION HAND SANITIZER PEONY BLUSH SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO3f53a401-86d9-45d6-a526-5efd00546a032025-10-13WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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