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 6 of 175 · 3,494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
inControl alcoholISOPROPYL ALCOHOLH-E-B45dfbd7a-0ae1-4146-9527-5483c884e6362026-08-18WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEThe Kroger Co.52f6258f-4b4c-49f4-9bc7-40dc3918869d2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLThe Kroger Co.b127bba1-ce0b-4142-8b7d-f12f062b09382026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.cd3f8779-9e57-4b23-a029-7424d4d4ab2a2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.ca6c7f8a-d41a-4d77-817c-3dbdc40f890e2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
application number: M003
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
Povidone-IodinePOVIDONE-IODINEMajor Pharmaceuticals59041ca3-a195-5a20-e063-6394a90a2ac92026-08-14WarningsExact identifier
application number: M003
Refresh AntiBac FOAMBENZALKONIUM CHLORIDESC Johnson Professional USA Inc.884d1c8c-5643-423e-8ed4-d2ef38f8af732026-08-13WarningsExact identifier
unii: F5UM2KM3W7
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
application number: M003
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsExact identifier
application number: M003
Antibacterial Hand White Tea and EucalyptusBENZALKONIUM CHLORIDEUpLift Brands LLCff075334-501e-4f71-a563-9581a495a67b2026-08-11Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
LUXURY IPA 70%LUXURY ISOPROPYL ALCOHOL 70% 16OZTSM BRANDS LLC2240a9e0-dac5-54fa-e063-6394a90a35f52026-08-11WarningsExact identifier
application number: M003
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Benzalkonium chlorideBENZALKONIUM CHLORIDENice-Pak Products, LLCe368e7b8-9695-4dd8-a49b-8c17c24c7f512026-08-10Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Ethyl alcoholETHYL ALCOHOLStrategic Sourcing Services LLC4fec6f1f-0249-423f-bd3c-427aa6924c6f2026-08-10Warnings, Adverse reactionsExact identifier
application number: M003
antibacterial hand wipes (JUICY WATERMELON)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.5883c43d-212b-af39-e063-6394a90ad6522026-08-08WarningsExact identifier
application number: M003
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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