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 174 of 295 · 5,897 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MISTIFY HAND SANITIZER MANGOALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0fd685-c807-75e4-e063-6394a90a3d652025-07-29WarningsExact identifier
unii: 3K9958V90M
MISTIFY HAND SANITIZER PEACHALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b104177-be18-8b50-e063-6394a90a3b392025-07-29WarningsExact identifier
unii: 3K9958V90M
MISTIFY HAND SANITIZER CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b4680c7-562f-c78b-e063-6294a90a5d1a2025-07-29WarningsExact identifier
unii: 3K9958V90M
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC003123d2-9675-fdd2-e063-6294a90a01302025-07-28WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20e0badf-fe25-1d27-e063-6294a90a7cfe2025-07-28WarningsExact identifier
unii: 15FIX9V2JP
Nourishing Sanitizing Hand Wipes EucalyptusALCOHOL SOLUTIONNoshinku3affe837-6789-6213-e063-6294a90a9fea2025-07-28WarningsExact identifier
unii: 3K9958V90M
Nourishing Sanitizing Hand Wipes LavendulaALCOHOL SOLUTIONNoshinku3b0016b4-ccad-5eb5-e063-6294a90a36ca2025-07-28WarningsExact identifier
unii: 3K9958V90M
Nourishing Sanitizing Hand Wipes BergamotALCOHOL SOLUTIONNoshinku3b0035e8-d95e-f5f2-e063-6394a90aca012025-07-28WarningsExact identifier
unii: 3K9958V90M
Kills Hand SanitizerALCOHOLDermazone LLCced12de7-32c1-4882-af22-f5373b2ceddb2025-07-25WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer MistETHYL ALCOHOLZhejiang Gaorong Cosmetic Co., Ltd.3abd4d79-3dd0-682a-e063-6294a90a28ef2025-07-25WarningsExact identifier
unii: 3K9958V90M
Dolce and Gabbana Everlast Foundation SPF 20 01N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L2ccf4e45-4cec-417d-9f4c-28f376025f1d2025-07-25WarningsExact identifier
unii: 15FIX9V2JP
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3aab23c1-53ad-9e60-e063-6394a90a26ec2025-07-24WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3aabb047-7277-d9cb-e063-6394a90a92242025-07-24WarningsExact identifier
unii: 3K9958V90M
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
unii: 15FIX9V2JP
ClinolipidOLIVE OIL AND SOYBEAN OILBaxter Healthcare Corporationae98eb03-c0e7-49d1-b024-77968e3d9d6e2025-07-24Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
unii: PDC6A3C0OX
Smart Care COCONUT BREEZE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.7088fa66-a972-4439-aef3-633808b5eafb2025-07-22WarningsExact identifier
unii: 3K9958V90M
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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