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 16 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56ca8257-6537-fb4e-e063-6294a90a49162026-07-17WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand Sanitizer Spray.ETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56caf683-bdf1-95e6-e063-6294a90a14d02026-07-17WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56cbbfcf-3239-7c76-e063-6394a90a75b02026-07-17WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56cd0c67-20dd-6783-e063-6294a90ae9102026-07-17WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCfbfa510c-2cc8-4ac8-95fc-5ac0a2e570ad2026-07-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Coconut Sweet ScentedALCOHOLFourstar Group USA, Inc.ab2c51c1-63ce-4175-9e57-420d23d21a052026-07-16WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Raspberry Silk ScentedALCOHOLFourstar Group USA, Inc.5f104a2c-a77b-47f0-abb1-69e9a8b8e0da2026-07-16WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Pink Berry Pop ScentedALCOHOLFourstar Group USA, Inc.51404513-fe1c-4456-995f-eb1f6df282262026-07-16WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56b733b1-8a15-0767-e063-6294a90af16b2026-07-16WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Pink Passionfruit ScentedALCOHOLFourstar Group USA, Inc.c7b7c7d8-5e38-47cb-a508-cc9054e147ef2026-07-16WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Sandy Sunset ScentedALCOHOLFourstar Group USA, Inc.e8dc6d52-eade-4c29-b27a-174d21065f8c2026-07-16WarningsExact identifier
unii: 3K9958V90M
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Aire-Master Foaming Hand Sanitizer Fragrance FreeALCOHOLWhisk Products, Inc.1c2915e1-6a95-4eab-afaa-82e41fd777902026-07-16WarningsExact identifier
unii: 3K9958V90M
Hand sanitizerHAND SANITIZER SPRAYBeimei Biotechnology (Guangzhou) Co., Ltd.56a22363-f531-d9bd-e063-6294a90a020b2026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Apple SplashALCOHOLMy Imports USA LLCf9113d29-64d7-40fe-986e-7541273a40202026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Berry CremeALCOHOLMy Imports USA LLC66801907-4803-4108-9e82-20fb1562686b2026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Beach SandalwoodALCOHOLMy Imports USA LLC4ccaffc1-e9db-4960-96fe-c40cc6ba03992026-07-15WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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