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 168 of 295 · 5,897 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foaming Facial CleanserGLYCERIN, NIACINAMIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd396c1db9-a5d3-cc82-e063-6294a90a90bb2025-08-23WarningsExact identifier
unii: PDC6A3C0OX
Solar Flare Hand Sanitizer Brazilian Caramel DreamsALCOHOLScent Theory Products LLC3d0d4ccf-ea31-cab2-e063-6294a90a4c692025-08-23WarningsExact identifier
unii: 3K9958V90M
Solar Flare Hand Sanitizer Sunset SambaALCOHOLScent Theory Products LLC3d0d7d6b-33a0-5cd1-e063-6394a90ac8f62025-08-23WarningsExact identifier
unii: 3K9958V90M
Solar Flare Hand Sanitizer Set Sea Veil, Pink Glow, Coco CremeALCOHOLScent Theory Products LLC3d0d7e73-8a83-9577-e063-6294a90aff6c2025-08-23WarningsExact identifier
unii: 3K9958V90M
OP-First Aid Series ALCOHOL PREP PADS STERILEISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co.,Ltd.351f4b1e-75c9-abec-e063-6294a90a28752025-08-22WarningsExact identifier
unii: ND2M416302
YehealCAMPHOR, MENTHOL, ISOPROPYL ALCOHOLShenzhen Yeheal Biotechnology Co., Ltd3cf1bc74-3060-6d63-e063-6294a90a9f5c2025-08-22WarningsExact identifier
unii: ND2M416302
70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.3cf2ff12-0220-3307-e063-6394a90abf082025-08-22WarningsExact identifier
unii: ND2M416302
Chain Drug Marketing Association, Inc.ISOPROPYL ALCOHOLChain Drug Marketing Association Inc.18fe4787-8986-4d64-e063-6394a90a35132025-08-22WarningsExact identifier
unii: ND2M416302
Scentfull Hand Sanitizer Eucalyptus AloeALCOHOLScent Theory Products LLC3cf7e175-239d-e13b-e063-6294a90a79062025-08-22WarningsExact identifier
unii: 3K9958V90M
Scentfull Hand Sanitizer Sunrise GlowALCOHOLScent Theory Products LLC3cf7fce1-3112-0d66-e063-6294a90a98652025-08-22WarningsExact identifier
unii: 3K9958V90M
Refresh RELIEVA PFCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.d5d3df4a-a311-4f2d-9a24-edfec1a6c9f92025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Refresh OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
unii: PDC6A3C0OX
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cdc1ae9-2924-5057-e063-6294a90ad2f32025-08-21WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3b21f1d8-534d-f4ea-e063-6294a90ad2eb2025-08-21WarningsExact identifier
unii: 15FIX9V2JP
AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7d0e8-12b4-e410-e053-2a95a90a7f302025-08-21WarningsExact identifier
unii: ND2M416302
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3ceb3368-439c-9f6c-e063-6294a90a98ba2025-08-21WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cc8b151-c07d-7473-e063-6294a90a1cc72025-08-20WarningsExact identifier
unii: 15FIX9V2JP
SEYEZINC OXIDE AND TITANIUM DIOXIDE CREAMGuangzhou Seye Biomedical Technology Co., Ltd.3cce91b1-311b-4c95-e063-6294a90a2d7a2025-08-20WarningsExact identifier
unii: 15FIX9V2JP
INSTANT HAND SANITIZER WIPESALCOHOL HAND SANITIZER WIPESDiamond Wipes International, Inc.e5d7bbcf-52b1-27d3-e053-2995a90a939f2025-08-19WarningsExact identifier
unii: 3K9958V90M
I-70 FoamingALCOHOL SANITIZERPeople's Janitorial Supply3cbabb95-c72f-6984-e063-6294a90adae02025-08-19WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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