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 12 of 174 · 3,476 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Molten Marshmallow Hand SanitizerALCOHOLScent Theory Products LLC572aa67e-52f7-b424-e063-6394a90ac4ae2026-07-21WarningsExact identifier
application number: M003
SoftSoap Antibacterial with moisturizers Fresh CitrusBENZALKONIUM CHLORIDEColgate-Palmolive Companyb1352731-9050-4e1b-a292-ab921c22160f2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Germ Free 24 Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incfa0cb8a1-d58a-4c7a-928e-2b071d9dd3ee2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial with moisturizers Crisp CleanBENZALKONIUM CHLORIDEColgate-Palmolive Company65d4de78-fa6f-4838-8217-0e3599cc09a02026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS SANITIZINGBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd56dc7a8-bee3-4eca-95cf-f1b0a6e2aad22026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DrugStore Antibacterial Hand WipesBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.56b621f2-eeaf-6ff1-e063-6394a90a88292026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITYBENZALKONIUM CHLORIDEQuest USA Corp57135b3f-884d-1a03-e063-6294a90ae3e92026-07-20WarningsExact identifier
application number: M003
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - PEACH PROSECCOBENZALKONIUM CHLORIDEQuest USA Corp571709fb-ca50-f7b1-e063-6394a90a8d352026-07-20WarningsExact identifier
application number: M003
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - TROPICAL ESCAPEBENZALKONIUM CHLORIDEQuest USA Corp57180e7a-1134-9ecd-e063-6294a90af5bf2026-07-20WarningsExact identifier
application number: M003
unii: F5UM2KM3W7
ALTA ANTIBACTERIAL HAND WIPESBENZALKONIUM CHLORIDEAlta Sales Inc9064a1b1-dd4a-4f74-99c4-5ea93b4be2102026-07-20WarningsExact identifier
unii: F5UM2KM3W7
Biopure 70% Isopropyl Alcohol WipeISOPROPYL ALCOHOL, WIPEQUEST USA CORP3a7932c4-6f90-a008-e063-6294a90aa7692026-07-19WarningsExact identifier
application number: M003
Meijer Antibacterial Spring Rain HandBENZALKONIUM CHLORIDEMeijer, Inc.35bbdd67-6d15-26b6-e063-6394a90a3f962026-07-19WarningsExact identifier
unii: F5UM2KM3W7
Urgent First Aid BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd5701c813-4346-a727-e063-6294a90a8e052026-07-19WarningsExact identifier
application number: M003
unii: F5UM2KM3W7
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.56a3ad5f-c34a-6b90-e063-6394a90a06e92026-07-19WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56ca8257-6537-fb4e-e063-6294a90a49162026-07-17WarningsExact identifier
application number: M003
Antibacterial Hand Sanitizer Spray.ETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56caf683-bdf1-95e6-e063-6294a90a14d02026-07-17WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56cbbfcf-3239-7c76-e063-6394a90a75b02026-07-17WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56cd0c67-20dd-6783-e063-6294a90ae9102026-07-17WarningsExact identifier
application number: M003
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDENANTONG HAIYIWEI TEXTILE CO., LTD.56cd55ee-b8ba-ddb9-e063-6394a90a1edc2026-07-17WarningsExact identifier
application number: M003
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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