FDA.reportPublic FDA data

NDC 68308-784-01 - 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
68308-784
Requested NDC
68308-784-01
Package NDCs from labels
68308-784-01, 68308-784-30
Manufacturer
Mayne Pharma
Effective date
2024-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isotretinoin - Mayne PharmaMayne Pharma2024-06-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68308-784-01Isotretinoin10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED104
68308-784-30Isotretinoin3 in 1 BOXCAPSULE, LIQUID FILLED34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-784ISOTRETINOIN CAPSULE, LIQUID FILLED [MAYNE PHARMA]4Current NDC, 2 package rows20240628_0114567b-3bac-490d-b9eb-03a6c5d90935.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-784-01EA - Each68308-784462faae8-2883-4ab8-904e-aad7aa61654212024-01-04
68308-784-30EA - Each68308-784a238822f-acae-4f2f-8696-c46354a4b72d12024-01-04

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 46 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MISTIFY WHIPPED STRAWBERRY HYDRATING HAND SANITISERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006097e-16e6-d180-e063-6394a90ae0c22026-04-22WarningsExact identifier
unii: 3K9958V90M
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUMHAIR GROWTH SERUMPutian Licheng District Zhijiancheng Trading Co., Ltd.409de2af-f6f6-8181-e063-6294a90a0b4b2026-04-22WarningsExact identifier
unii: 3K9958V90M
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUMMINOXIDILPutian Licheng District Zhijiancheng Trading Co., Ltd.5009b231-23c3-7356-e063-6394a90a569f2026-04-22WarningsExact identifier
unii: 3K9958V90M
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Sanitizing Wipes LavenderALCOHOLThe Honest Company Inc.4a69b1d5-81ad-2cd1-e063-6294a90ac62d2026-04-22WarningsExact identifier
unii: 3K9958V90M
Sanitizing Wipes GrapefruitALCOHOLThe Honest Company Inc.4aa8c899-e5c3-9eec-e063-6294a90a6eae2026-04-22WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER Golden Tangerine ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO82c7f67c-dca8-4859-b945-db34a039cc3d2026-04-22WarningsExact identifier
unii: 3K9958V90M
3M Avagard DALCOHOLSolventum US LLC220c8a49-2a52-4660-8ad4-de553bd032262026-04-22WarningsExact identifier
unii: 3K9958V90M
3M AvagardCHLORHEXIDINE GLUCONATE AND ALCOHOLSolventum US LLC8bf8fe8e-76cb-4eda-a18d-1687050285ae2026-04-22WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COTTON CANDY SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited0f96981b-6ba0-4993-b35e-4d430b0f44ff2026-04-22WarningsExact identifier
unii: 3K9958V90M
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
unii: PDC6A3C0OX
Santa and Friends Hand Sanitizers Santa Cookies, Caramel Vanilla Snuggle, Frosted Marshmallow, Winterberry CrumbleALCOHOL SPRAYScent Theory Products LLC4ffa6e26-870f-586e-e063-6394a90ad9752026-04-21WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLTarget Corporation5c6be1e4-ae02-430c-8ed7-2148660da19d2026-04-21Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Solar Flare Sunlit Holiday Hand Sanitizers (Golden Caramel, Vanilla Solstice, Amber Rose)ALCOHOL SPRAYScent Theory Products LLC4fc170dd-7c6b-b810-e063-6394a90ae61f2026-04-18WarningsExact identifier
unii: 3K9958V90M
Smart Care APPLE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3a377d37-28c3-4cd6-8633-8b13464a28ef2026-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care MISTLETOE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.24534267-52d9-47c9-bb83-913c3a0f29d12026-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care PUMPKIN SPICE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5f7ddccc-58da-4c86-b2b4-9de17e12922d2026-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care CANDY CANE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.84b0158c-4450-4a15-a01d-8592ae8c9c162026-04-17WarningsExact identifier
unii: 3K9958V90M
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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