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 256 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadALCOHOL PREP PADBioMed Resource Inc.03be8a96-c163-0e22-e054-00144ff8d46c2024-01-10WarningsExact identifier
unii: ND2M416302
Meijer 70 Isopropyl Alcohol Wipes First Aid AntisepticISOPROPYL ALCOHOLMeijer, Inc2046162f-cb70-416c-ae37-14999883a8072024-01-09WarningsExact identifier
unii: ND2M416302
EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd4de3c7b-3993-40e5-88a4-f6005ab975312024-01-09WarningsExact identifier
unii: 15FIX9V2JP
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: PDC6A3C0OX
Principal Secret Reclaim Oil Control hydrator SPF-8TITANIUM DIOXIDEGuthy-Renker LLC97b7cd4e-78aa-418b-a112-263971fa98272024-01-08WarningsExact identifier
unii: 15FIX9V2JP
Prime Time Daily Protecting Primer SPF 30SPF 30 PRIME TIME PRIMERAutumn Harp Inc.f2619092-3e7f-5105-e053-2a95a90a3f5a2024-01-03WarningsExact identifier
unii: 15FIX9V2JP
ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDEAmway Corpa1a700b5-d039-4bd2-8420-5c20530957062024-01-02WarningsExact identifier
unii: 15FIX9V2JP
Josie Maran Argan Daily Moisturizer SPF47 Protect and PerfectZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.cb91c130-45d4-46a0-9628-50e701a6960c2024-01-02Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
Exchange Select Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLArmy and Air Force Exchange Service318bc025-c936-a066-e063-6294a90a47122024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Kroger Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEThe Kroger Co.318dea21-2656-36a3-e063-6294a90ac9c42024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Equaline Redness Relief Lubricant Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc31a30b00-9f4b-717a-e063-6394a90a8a872024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Harris Teeter Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLC.31a3d575-10f1-5feb-e063-6294a90ac4782024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Discount Drug Mart Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.31a98e6c-42df-6b56-e063-6294a90a35642024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Harris Teeter Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLHarris Teeter, LLC.31ac6883-ffc6-39de-e063-6294a90a52dd2024-01-01WarningsExact identifier
unii: 6DC9Q167V3
Exchange Select High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArmy and Air Force Exchange Service31ac8bd2-c2e9-6f2c-e063-6394a90adc722024-01-01WarningsExact identifier
unii: 6DC9Q167V3
CVS Health Fast Acting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVS Pharmacy, Inc.31addfd2-52f2-05b3-e063-6294a90a337f2024-01-01WarningsExact identifier
unii: 6DC9Q167V3
La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox ShieldTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incc0f7ae46-7161-4d48-9386-007bfafecfd52024-01-01WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc7bca5947-88a3-4cb3-a6f2-9fa389d344ef2024-01-01WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc89b59bd7-9a91-4b99-84e7-996a8b1d499e2024-01-01WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc6d3c5fc5-c818-46c4-8db3-cffcdcd56e062023-12-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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