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 34 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MISTIFY WINTER GREEN HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e54e1b-048f-805b-e063-6294a90ae1542026-06-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY WINTER BERRY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552a96d0-bbe7-228b-e063-6294a90a41fb2026-06-01WarningsExact identifier
unii: 3K9958V90M
cookie glow hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552b129a-6ec2-9418-e063-6294a90a2d5e2026-06-01WarningsExact identifier
unii: 3K9958V90M
Vanilla Fleece Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552b83dd-3809-02e6-e063-6294a90a997f2026-06-01WarningsExact identifier
unii: 3K9958V90M
Berry Swirl Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552bc4ba-b9a9-4bea-e063-6394a90acfc02026-06-01WarningsExact identifier
unii: 3K9958V90M
BAJA BLAST HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552d9b48-34ed-8bb9-e063-6294a90a06c52026-06-01WarningsExact identifier
unii: 3K9958V90M
MOUNTAIN DEW HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552e7850-248f-dbc2-e063-6394a90a9cfd2026-06-01WarningsExact identifier
unii: 3K9958V90M
CORE RED HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552e7850-2492-dbc2-e063-6394a90a9cfd2026-06-01WarningsExact identifier
unii: 3K9958V90M
PEPSI HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552e9e41-0573-94da-e063-6294a90aa8ec2026-06-01WarningsExact identifier
unii: 3K9958V90M
vanilla sugar hand sanitizer gelALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd567c99e6-3bc8-0600-e063-6294a90a94c92026-06-01WarningsExact identifier
unii: 3K9958V90M
very berry hand sanitizer gelALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd567d6ce2-59fa-01ae-e063-6394a90a9e782026-06-01WarningsExact identifier
unii: 3K9958V90M
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
Smart Care WHISPERING WOODS HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.dce079a4-3984-4258-82f8-7e90da31e12c2026-05-29WarningsExact identifier
unii: 3K9958V90M
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
ProCure Foaming Hand SanitizerETHYL ALCOHOL 72%Twin Med LLC3d848ec8-5197-6d39-e063-6394a90aaef62026-05-29WarningsExact identifier
unii: 3K9958V90M
Smart Care MEADOW MIRAGE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3157d8d9-35ac-4157-b97d-4cc2b6bd812e2026-05-29WarningsExact identifier
unii: 3K9958V90M
Smart Care MIDNIGHT MUSK HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.4a9d80b7-619a-4eba-9535-ea7605b6cd712026-05-29WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLZhejiang Gaorong Cosmetic Co., Ltd.52db71d5-42fc-c3b6-e063-6394a90aea152026-05-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Creamy Macadamia ScentedALCOHOLFourstar Group USA, Inc.e59282f1-82f1-465e-9db3-f207177151e62026-05-28WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerALCOHOLHubei Fanjian Medical Product Co.,Ltd9b4014a3-6296-4628-9cc6-b8d4ef4a25f32026-05-28WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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