FDA.reportPublic FDA data

NDC 68462-318-84 - VIORELE

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
68462-318
Requested NDC
68462-318-84
Package NDCs from labels
68462-318-84, 68462-318-29
Manufacturer
A-S Medication Solutions
Effective date
2026-06-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VIORELE - A-S Medication SolutionsA-S Medication Solutions2026-06-23HUMAN PRESCRIPTION DRUG LABEL
VIORELE - Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-01-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-318-29VIORELE3 in 1 CARTONKIT317
68462-318-84VIORELE1 in 1 BLISTER PACKKIT117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-318VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]16Current NDC, Legacy NDC, 2 package rows20240706_39988aa6-8f68-40e8-9bdd-c40a3bdaad61.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-318-29EA - Each68462-31827ce87fe-35ea-47a8-b0ad-9a3ab5e9799b12012-07-24
68462-318-84EA - Each68462-3182b7f66e1-3574-4f3b-9074-7ae21d0a948512026-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESOGESTRELACTIVE INGREDIENT81K9V7M3A3VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
DESOGESTRELACTIVE MOIETY81K9V7M3A3VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
POVIDONE K30INACTIVE INGREDIENTU725QWY32XVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
TALCINACTIVE INGREDIENT7SEV7J4R1UVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]6

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 1 of 184 · 3,676 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
unii: ND2M416302
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
unii: ND2M416302
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
unii: ND2M416302
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
unii: ND2M416302
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cbbe72-24ec-2e4a-e063-6394a90abbd22026-09-07WarningsExact identifier
unii: ND2M416302
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
unii: ND2M416302
Members MarkISOPROPYL ALCOHOLSams West Incc251ac50-f74f-4a48-e053-2a95a90aac0d2026-09-04WarningsExact identifier
unii: ND2M416302
WalmartISOPROPYL ALCOHOLWalmart, Inc.2f1342ef-1843-40a6-e063-6294a90a577f2026-09-04WarningsExact identifier
unii: ND2M416302
Curad Alcohol Prep Pads MediumISOPROPYL ALCOHOLMedline Industries, LP1ce3872e-2307-4a38-bd7d-7eb2b226cf3c2026-09-04WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLSuperValu, Inc.5e6e6d6f-4472-40f1-b0a9-96cee7ef075b2026-09-04WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLFoodhold U.S.A. LLCa94c023c-5313-4940-90a7-b3061a8b90e12026-09-04WarningsExact identifier
unii: ND2M416302
MeijerISOPROPYL ALCOHOLMeijer Distribution Incca008d84-cf51-3703-e053-2a95a90a9bf12026-09-04WarningsExact identifier
unii: ND2M416302
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
WalmartISOPROPYL ALCOHOLWalmart, Inc.2eff98ba-5736-b07e-e063-6394a90aeea92026-09-04WarningsExact identifier
unii: ND2M416302
Walgreen AlcoholISOPROPYL ALCOHOLWalgreens Companydeeae1ea-3d81-4260-95be-c4f328e3fdef2026-09-04WarningsExact identifier
unii: ND2M416302
Dollar GeneralISOPROPYL ALCOHOLDollar General Corporation00b2ef34-42d9-523c-e063-6294a90a753d2026-09-03WarningsExact identifier
unii: ND2M416302
Signature Select Alcohol Prep PadsISOPROPYL ALCOHOLBetter Living Brands LLC31ce72e3-03a3-1608-e063-6394a90ad8502026-09-03WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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