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 21 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
American Red Cross IPA 50% 6ozAMERICAN RED CROSS IPA 50% 6OZTSM BRANDS LLC29195bac-b096-ab8d-e063-6394a90a424a2026-07-01WarningsExact identifier
unii: ND2M416302
American Red Cross 6oz, 50% Isopropyl AlcoholAMERICAN RED CROSS 6 OZ, 50% ISOPROPYL ALCOHOL SPRAYMY IMPORTS USA LLC2929d580-cfff-e2b6-e063-6394a90a79aa2026-07-01WarningsExact identifier
unii: ND2M416302
Medi Fect Antiseptic Hand WashETHYL ALCOHOLMedical Chemical Corporationdc397d9c-9c12-41e5-ab7f-196fcad5bf972026-07-01WarningsExact identifier
unii: 3K9958V90M
AloeSafe Antiseptic Hand SanitizerETHYL ALCOHOLMedical Chemical Corporation950f012e-7908-523c-e053-2995a90afa6b2026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Berry BlissALCOHOLBath & Body Works, Inc.55935d41-ce7a-796a-e063-6294a90a6ba22026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Tangerine TwirlALCOHOLBath & Body Works, Inc.55933da8-dfbc-6877-e063-6394a90abb7f2026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Watermelon WhirlALCOHOLBath & Body Works, Inc.559364cc-2b55-9628-e063-6394a90ac8e62026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach SandalwoodETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55984504-188f-13bc-e063-6394a90a91502026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber GlowETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5597ed5f-ed98-ebeb-e063-6294a90a2e8d2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry CremeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5598c831-3986-00a5-e063-6394a90a1e662026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple SplashETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55982f73-7baa-26a7-e063-6394a90ab74b2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry CrumbleETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55981d2a-d4de-af08-e063-6294a90a4b7c2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti CupcakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5597ff1f-b134-0beb-e063-6394a90a39a12026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread CakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5598d6ca-39f6-ca2a-e063-6394a90abc0e2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha MistETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559832ca-df92-0c2d-e063-6294a90ab66f2026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pistachio GlowETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5599605b-28f0-a534-e063-6394a90a72132026-07-01WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin CreamETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559987c0-7abd-13fc-e063-6294a90a9f272026-07-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY STRAWBERRE HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5740a2ed-e77d-3f41-e063-6394a90aec032026-07-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY VANILLA HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574ba9b9-b44d-b014-e063-6394a90af7682026-07-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY COTTON CANDY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574bcf4f-ad36-5ede-e063-6294a90a0eab2026-07-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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