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 137 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOUR LEMON Hand Sanitizer SWEET CHERRY SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO54039b3a-8ad5-4251-a48e-6eded738dd592025-12-01WarningsExact identifier
unii: 3K9958V90M
AMORA Spray. Hand Sanitizer CherryALCOHOLLongway Technology(Guangzhou) Co., Ltd.44e04959-a21e-ba62-e063-6394a90a71922025-12-01WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizing WipeALCOHOLNeatGoods LLCb700ff10-2836-7893-e053-2995a90a43222025-12-01WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLNeatGoods LLCf7584f1a-e459-98f9-e053-6394a90a87922025-12-01WarningsExact identifier
unii: 3K9958V90M
CareALL Hand SanitizerALCOHOLNew World Imports, Inc.025a42bb-37e0-4d74-8f94-8a9ef2296f4c2025-12-01WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.263457cc-35ff-62fb-e063-6394a90a94da2025-12-01WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.2507df2c-9069-01c1-e063-6394a90a85962025-12-01WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer SOUFFLE VANILLA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO8436deda-2a91-446a-9633-53965cf33beb2025-12-01WarningsExact identifier
unii: 3K9958V90M
BUDDATE INONOTUS OBLIQUUS WATER BRILLIANCE MASKBUTYLENE GLYCOL, GLYCERIN, INONOTUS OBLIQUUS (MUSHROOM) EXTRACTBUDDATE Co Ltd464988ad-557e-13f5-e054-00144ff8d46c2025-11-30WarningsExact identifier
unii: PDC6A3C0OX
BUDDATE LOTUS MOISTURE ESSENCEGLYCERIN, NIACINAMIDE, NELUMBO NUCIFERA FLOWER EXTRACT, PORTULACA OLERACEA EXTRACTBUDDATE Co Ltd46499995-8b13-3e5c-e054-00144ff88e882025-11-30WarningsExact identifier
unii: PDC6A3C0OX
BCBGENERATION HAND SANITIZER HIBISCUS SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO36d72b23-a4ab-4196-b773-5bf5ddafa5262025-11-29WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer CUCUMBER MELON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2a6d6230-e9df-4af1-96ed-36efe1df8f292025-11-28WarningsExact identifier
unii: 3K9958V90M
EO Hand Sanitizer Wipes LavenderALCOHOLEO Products, LLCb66895a9-17eb-4493-aa9d-7ef4b2b0194a2025-11-27WarningsExact identifier
unii: 3K9958V90M
Alcohol WipesALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD448e7c82-f952-4993-e063-6394a90a942c2025-11-27WarningsExact identifier
unii: 3K9958V90M
FF SILICONE SPRY SANI PPKFF SILICONE SPRY SANI PPKZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD4493c534-187e-f680-e063-6294a90aacdb2025-11-27WarningsExact identifier
unii: 3K9958V90M
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
unii: 15FIX9V2JP
everyone Hand Sanitizer Coconut LemonALCOHOLEO Products, LLC16528009-90cf-46b8-9719-bdc6f435a1912025-11-27WarningsExact identifier
unii: 3K9958V90M
Everyone Hand Sanitizer ruby grapefruitALCOHOLEO Products, LLC045151b3-f08c-4e02-be33-00271e15b7f02025-11-27WarningsExact identifier
unii: 3K9958V90M
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
unii: 6DC9Q167V3
Hand SanitizerETHYL ALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.44677bab-41ea-3392-e063-6394a90a61872025-11-25WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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