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 100 of 295 · 5,897 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand sanitizer 2oz 2pk with aloe veraETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.04fe378d-ee1e-ad52-e063-6294a90ae1462026-01-05WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer 2oz 2pk lemonETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.04fe16d8-1824-34fe-e063-6394a90a7ab12026-01-05WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.0fbc45c1-c7e8-bded-e063-6394a90a31d12026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Monster JamALCOHOLShenzhen Lantern Scicence Co.,Ltd.47afe5bd-5e06-7300-e063-6294a90a94e82026-01-05WarningsExact identifier
unii: 3K9958V90M
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 PlusTITANIUM DIOXIDEHEY HONEY INC.21187805-fae9-476c-81b0-27ffeb0b99112026-01-05WarningsExact identifier
unii: 15FIX9V2JP
Bellas Friends Roll-on SunscreenTITANIUM DIOXIDE, ZINC OXIDEPANERGYTEK USA INC478d46ce-14e8-2231-e063-6394a90a3e272026-01-04WarningsExact identifier
unii: 15FIX9V2JP
Beauty Creations Pink Halo Hand Sanitizer MistETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.dda9f4cb-e431-4164-be61-0daf1a86d10f2026-01-04WarningsExact identifier
unii: 3K9958V90M
Walgreens Hand Sanitizer watermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.479b898c-0dff-98fe-e063-6294a90ade202026-01-04WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.479beac0-16bc-a88c-e063-6394a90a42f52026-01-04WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Silicone Case 3pkALCOHOLShenzhen Lantern Scicence Co.,Ltd.478b0ba2-d8ce-8101-e063-6294a90a64642026-01-03WarningsExact identifier
unii: 3K9958V90M
CASA COLADA SAPRY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd47679265-2ec3-4c62-e063-6294a90a60b62026-01-02WarningsExact identifier
unii: 3K9958V90M
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
unii: PDC6A3C0OX
Fiji Punch Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4767ed4b-ebec-ca75-e063-6294a90a82d32026-01-02WarningsExact identifier
unii: 3K9958V90M
VILLA VANILLA HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd47682ec1-5479-2ea5-e063-6394a90aa1922026-01-02WarningsExact identifier
unii: 3K9958V90M
Quik-Care Nourishing Foam Hand SanitizerALCOHOLEcolab Inc.f83bbb1f-b1a9-42cd-ae46-168815cfefb52026-01-02WarningsExact identifier
unii: 3K9958V90M
Alcohol PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.74dc43d1-2aba-4f8a-876a-ce712ad37eeb2026-01-01WarningsExact identifier
unii: ND2M416302
OP First Aid Series Alcohol Prep PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co., Ltd.b3da7cff-4555-358e-e053-2995a90ae0ff2026-01-01WarningsExact identifier
unii: ND2M416302
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.116ee6dc-9c49-2e11-e063-6394a90a44ed2026-01-01WarningsExact identifier
unii: ND2M416302
CHEMSTAR RETAIL HAND SANITIZERALCOHOLEcolab Inc.3d874e95-48d0-4383-97df-b97d54d1648c2025-12-31WarningsExact identifier
unii: 3K9958V90M
Kay Actigel Hand SanitizerETHANOLEcolab Inc.059559eb-01ce-4a0f-bede-a3d3cbfb60552025-12-31WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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