FDA.reportPublic FDA data

NDC 68915-280-01 - Guardian Vaginal

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
68915-280
Requested NDC
68915-280-01
Package NDCs from labels
68915-280-01, 68915-280-02
Manufacturer
Eastern Century Pharmaceuticals | Woodbine Products Company
Effective date
2024-04-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guardian Vaginal - Eastern Century Pharmaceuticals | Woodbine Products CompanyEastern Century Pharmaceuticals | Woodbine Products Company2024-04-24HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68915-280-022024-04-24C16284748780-1ba0f9c33-1e5c-a910-e053-dadaa90a0b85Eastern Century - Guardian Gel Vaginal Douche
68915-280-022021-01-29C16284748780-1ba0f9c33-1e5c-a910-e053-dadaa90a0b85Eastern Century - Guardian Gel Vaginal Douche

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68915-280-01GuardianVaginal5.5 mL in 1 BOTTLEDOUCHE5.511
68915-280-02GuardianVaginal1 in 1 BOXDOUCHE111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68915-280GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]11Current NDC, Legacy NDC, 2 package rows20240426_1605ba44-02b7-4c72-9fec-89a5aa962b44.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]8
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YGUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]8
CARBOMER 934INACTIVE INGREDIENTZ135WT9208GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]8
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]8
WATERINACTIVE INGREDIENT059QF0KO0RGUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]8

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 2 of 175 · 3,494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
application number: M003
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
application number: M003
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
application number: M003
Members MarkISOPROPYL ALCOHOLSams West Incc251ac50-f74f-4a48-e053-2a95a90aac0d2026-09-04WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart, Inc.2f1342ef-1843-40a6-e063-6294a90a577f2026-09-04WarningsExact identifier
application number: M003
Curad Alcohol Prep Pads MediumISOPROPYL ALCOHOLMedline Industries, LP1ce3872e-2307-4a38-bd7d-7eb2b226cf3c2026-09-04WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLSuperValu, Inc.5e6e6d6f-4472-40f1-b0a9-96cee7ef075b2026-09-04WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLFoodhold U.S.A. LLCa94c023c-5313-4940-90a7-b3061a8b90e12026-09-04WarningsExact identifier
application number: M003
MeijerISOPROPYL ALCOHOLMeijer Distribution Incca008d84-cf51-3703-e053-2a95a90a9bf12026-09-04WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart, Inc.2eff98ba-5736-b07e-e063-6394a90aeea92026-09-04WarningsExact identifier
application number: M003
Walgreen AlcoholISOPROPYL ALCOHOLWalgreens Companydeeae1ea-3d81-4260-95be-c4f328e3fdef2026-09-04WarningsExact identifier
application number: M003
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
Dollar GeneralISOPROPYL ALCOHOLDollar General Corporation00b2ef34-42d9-523c-e063-6294a90a753d2026-09-03WarningsExact identifier
application number: M003
Signature Select Alcohol Prep PadsISOPROPYL ALCOHOLBetter Living Brands LLC31ce72e3-03a3-1608-e063-6394a90ad8502026-09-03WarningsExact identifier
application number: M003
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEKroger Co.fe604470-917f-4cbd-a1e6-ac1dc7c57ff62026-09-02WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLRite Aid Corporation5104f9ab-0b28-449f-a55a-5438713a24df2026-09-02WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUpLift Brands, LLC5a81b635-d188-0b29-e063-6294a90a1e4b2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDECVS Pharmacy, Inc.7f518646-c8fe-499a-b5e4-8e5a5a90e01d2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLThe Kroger Company6551187f-5cde-4149-931f-b057bd7607502026-09-02WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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