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 11 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrating Hand Sanitizer PASSION MANGO SPLASHALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585df6ce-4625-d5d2-e063-6394a90a7fcb2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer LILY SPRINGSALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e0c24-7f5f-4ba7-e063-6294a90a75972026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer WATERMELON POPALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e3ced-fa45-8576-e063-6294a90af50f2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer ALOE BREEZEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e647c-2904-2d3f-e063-6394a90a2b792026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer LAVENDER DREAMALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e8222-fad5-4409-e063-6394a90a9c602026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer JUICY APPLEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585eb222-5495-65ed-e063-6394a90a7cfa2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer PEACH GLOWALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585ed56e-362e-7c50-e063-6394a90a19322026-08-06WarningsExact identifier
unii: 3K9958V90M
Uline Hand SanitizerALCOHOLUlinea7aa3bde-d36e-f9d4-e053-2a95a90a6e6a2026-08-06WarningsExact identifier
unii: 3K9958V90M
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MagiCare Premium Hand Sanitizing Wipes LavenderALCOHOLMagicare Tech Corp9b66b3bd-1e08-485e-b961-b67a2fcc47512026-08-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Hyaluronic Acid Enchanted Rose ScentedALCOHOLFourstar Group USA, Inc.b8216dd0-82e9-411c-b045-d6966a17f18e2026-08-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Collagen Sugared Iris ScentedALCOHOLFourstar Group USA, Inc.c5b42ae3-475d-444c-8ff0-784f02ec0ee42026-08-06WarningsExact identifier
unii: 3K9958V90M
Isopropyl alcohol 70 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLC57c496b3-10ab-4a72-8d8f-42a2256189dd2026-08-06WarningsExact identifier
unii: ND2M416302
Smart Care Sweet Pea HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.143082de-5f48-4229-a39e-fd6aa38acf302026-08-06WarningsExact identifier
unii: 3K9958V90M
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Smart Care Cherry Blossom HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.ba91112c-5091-4972-84c9-5447eb0b504c2026-08-06WarningsExact identifier
unii: 3K9958V90M
PROHEAL ALCOHOL PREP PADSISOPROPYL ALCOHOLClick Industries LLCd272c1f6-e9c9-4099-9d24-f5aae44082ae2026-08-05WarningsExact identifier
unii: ND2M416302
Hand Sanitizer GelETHYL ALCOHOLApollo Health and Beauty Care5245e2a0-f871-ded0-e063-6394a90a86072026-08-05WarningsExact identifier
unii: 3K9958V90M
Vitamin E and AloeETHYL ALCOHOLApollo Health and Beauty Care52460290-a376-24b3-e063-6394a90a63482026-08-05WarningsExact identifier
unii: 3K9958V90M
Gingerbread Scented Hand SanitizerETHYL ALCOHOLPacific World Corporation5014eea8-6ee3-5ed2-e063-6294a90adac42026-08-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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