FDA.reportPublic FDA data

NDC 0832-8302-89 - 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
0832-8302
Requested NDC
0832-8302-89
Package NDCs from labels
0832-8302-89, 0832-8302-30
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
0832-8302-30Isotretinoin3 in 1 BOXCAPSULE, LIQUID FILLED33
0832-8302-89Isotretinoin10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-8302ISOTRETINOIN 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
0832-8302-30EA - Each0832-8302136d3c3f-cecc-4476-91a4-aca1c8d4f73e12023-07-06
0832-8302-89EA - Each0832-830209b06a7e-0ee4-4837-bfb5-ed1925a6912e12023-08-08

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 53 of 295 · 5,897 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SeranovaTM ULTRALIGHT SPF50 SERUMSERANOVATM ULTRALIGHT SPF50 SERUMGuangzhou Ariel Biotech Co., Ltd.4e5d716d-2b2d-d42f-e063-6294a90a1e522026-03-31WarningsExact identifier
unii: 15FIX9V2JP
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4e404989-89d0-b189-e063-6394a90a8caa2026-03-30WarningsExact identifier
unii: ND2M416302
MedPride Sterile Prep PadsISOPROPYL ALCOHOLShield Line LLC31de24d8-b70e-47f1-8946-6bd9fb16b5d52026-03-30WarningsExact identifier
unii: ND2M416302
FIGS - evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLWE EVOLVETOGETHER INC.4e432300-7d2f-ed59-e063-6394a90a22b82026-03-30WarningsExact identifier
unii: 3K9958V90M
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
unii: PDC6A3C0OX
IsagelALCOHOLColoplast Corpeba7e574-25c2-445a-98f6-2d10454554662026-03-27WarningsExact identifier
unii: 3K9958V90M
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
unii: PDC6A3C0OX
Giant EagleALCOHOLApollo Health and Beauty Care419846a1-8d22-16f0-e063-6394a90a6bdd2026-03-27WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Fragrance FreeALCOHOLGOJO Industries, Inc.4e06bb4a-e1a5-8c79-e063-6294a90a293c2026-03-27WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer be BlissfulALCOHOLGOJO Industries, Inc.cebd0adb-dc26-407f-a290-418e0e206aea2026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Fig ScentedALCOHOLFourstar Group USA, Inc.b66cd8a7-98ea-43b0-a92b-7d1da15f50142026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Cherry ScentedALCOHOLFourstar Group USA, Inc.290674c5-1622-451e-abd6-b586117827c32026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Vanilla Honey ScentedALCOHOLFourstar Group USA, Inc.f2eb0f80-083e-478a-a8df-0d2bb85901ad2026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Peachy Cherry Bliss ScentedALCOHOLFourstar Group USA, Inc.835a6a4c-1582-46fd-b5c3-4b79dbe11d502026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand SanitizerSugared Strawberry ScentedALCOHOLFourstar Group USA, Inc.15e732fe-5c4b-4f3a-9dd5-a4f7015f75422026-03-27WarningsExact identifier
unii: 3K9958V90M
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADETITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC4e0bd355-99c6-8cf4-e063-6294a90ab4b32026-03-27WarningsExact identifier
unii: 15FIX9V2JP
IsagelALCOHOLColoplast Corp5be93a24-c644-4e6b-a600-87f0a5a09e5c2026-03-27WarningsExact identifier
unii: 3K9958V90M
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: PDC6A3C0OX
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On MineralZINC OXIDE, TITANIUM DIOXIDEClassic Cosmetics LLC4df3b8c0-71bc-acdd-e063-6394a90a35c02026-03-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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