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 137 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Hand Sanitizer Coconut Vanilla ScentedALCOHOLFourstar Group USA, Inc.08d9499c-486c-464b-9d81-ba325b95482e2025-12-04WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Palm Sugar Pineapple ScentedALCOHOLFourstar Group USA, Inc.34d065a1-c5f0-4ba0-8c1b-717049dcb83a2025-12-04WarningsExact identifier
unii: 3K9958V90M
FoamFresh Alco-Foam Hand SanitizerALCOHOLWoodbine Products Company2e9c752c-ad69-4692-a17a-e98b84c7e9a52025-12-04WarningsExact identifier
unii: 3K9958V90M
Mrs. Meyers Clean Day Hand Sanitizer Lavender ScentALCOHOLThe Caldrea Companyd60a985b-6b42-44ea-b48e-81556e4f609a2025-12-04WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Jasmine GardeniaALCOHOLShenzhen Lantern Scicence Co.,Ltd.45082749-6f53-c595-e063-6294a90ac3e92025-12-03WarningsExact identifier
unii: 3K9958V90M
ALCOHOL PREP PAD70% ISOPROPY ALCOHOL SWABPurCel Labs LLC450c39fd-d172-492e-e063-6294a90aa3962025-12-03WarningsExact identifier
unii: ND2M416302
Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLHumco Holding Group, Inc.41c0927e-df40-4f83-8fd4-284ec0c02b602025-12-03WarningsExact identifier
unii: 3K9958V90M
The Green ScissorISOPROPYL ALCOHOL 99%The Green Scissor Incc1fbb53e-b547-0615-e053-2995a90a51512025-12-03WarningsExact identifier
unii: ND2M416302
The Green ScissorISOPROPYL ALCOHOL 99%The Green Scissor Incc1fb4069-b926-266b-e053-2995a90acab92025-12-03WarningsExact identifier
unii: ND2M416302
Smart Care Hand Sanitizer StrawberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.451752d3-88bc-9a26-e063-6294a90a288a2025-12-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 3pk - Floral Fresh (Lavender/Wild rose/Rain)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.45179a84-fa3c-5634-e063-6294a90a0eee2025-12-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 3pk - Classic Men (Ocean/Sandalwood/Cedar and cypress)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.451711f3-3b22-5d39-e063-6294a90a78942025-12-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 3pk (Pistachio Brulee / Vanilla Shea /Caramel Honey)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.4518038c-04ac-0fbe-e063-6294a90a7c322025-12-03WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerANTISEPTIC GELHART Health87fcd27f-e4bf-4ae9-ad2e-b9b11ac554cc2025-12-02WarningsExact identifier
unii: 3K9958V90M
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd44f609dd-c864-493f-e063-6294a90a71382025-12-02WarningsExact identifier
unii: 3K9958V90M
AMORA Spray. Hand Sanitizer WatermelonALCOHOLLongway Technology(Guangzhou) Co., Ltd.-44fc6694-2933-8700-e063-6294a90a274f2025-12-02WarningsExact identifier
unii: 3K9958V90M
AMORA Spray. Hand Sanitizer coconutALCOHOLLongway Technology(Guangzhou) Co., Ltd.44fcf3d3-439b-7869-e063-6294a90a19c32025-12-02WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Spray, Palm Sugar Pineapple ScentedALCOHOLFourstar Group USA, Inc.616c5315-690e-437f-b348-24754d9a23462025-12-02WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand SanitizerTropical Burst ScentedALCOHOLFourstar Group USA, Inc.67fe2f38-ed73-4fe7-9056-fa87f73004032025-12-02WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Moonlight Orchid ScentedALCOHOLFourstar Group USA, Inc.4717e3d9-e10c-40d5-9903-af4087e1577b2025-12-02WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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