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 35 of 173 · 3,453 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4ef56b6c-ad46-2d02-e063-6294a90ad4072026-04-08WarningsExact identifier
application number: M003
RubbingETHYL ALCOHOLPerrigo Direct, Incba2266d7-da25-495a-b035-97e149551c302026-04-08Warnings, Adverse reactionsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efeb523-0a73-2e48-e063-6394a90aac5e2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels RedALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efefd07-c1df-695a-e063-6294a90a51eb2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eff601c-7bcd-1ddd-e063-6294a90a80402026-04-08WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Ocean BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4effb28e-fa83-5a06-e063-6394a90aa2f52026-04-08WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLPerrigo Direct, Incf953a249-07ad-40a1-8aea-b2d419fd3d4d2026-04-07Warnings, Adverse reactionsExact identifier
application number: M003
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
unii: PDC6A3C0OX
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Amazon.com Services LLC69c33a40-9903-4607-b37e-530c0b38d0852026-04-06Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
50% RubbingISOPROPYL ALCOHOLPerrigo Direct, Inc698bede7-4fc1-4e85-8ac4-d735f409cfae2026-04-06Warnings, Adverse reactionsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLAmazon.com Services LLC5369424a-ccbd-4dc6-af6b-7876484a9fe62026-04-06Warnings, Adverse reactionsExact identifier
application number: M003
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Caring Mill Triple Hand Sanitizer with LavenderETHYL ALCOHOLFSA Store Inc. (Caring Mills)4b0b5436-a1ce-cfa6-e063-6394a90a2efe2026-04-04WarningsExact identifier
application number: M003
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Smart Care Hand Sanitizer Passion ParadiseALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e850ea9-0999-12b4-e063-6394a90af4062026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Tropical MangoALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85630a-6d18-e6a4-e063-6394a90a1d122026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Coco CabanaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85923b-6b8c-f9a2-e063-6294a90a0d8e2026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Sea BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85e279-7751-8bd7-e063-6294a90a095b2026-04-02WarningsExact identifier
application number: M003
Aterra7 Antibacterial Foaming Hand Fragrance FreeBENZALKONIUM CHLORIDEB4 Soap LLC25280f7c-9543-c4ff-e063-6394a90aee0f2026-04-01WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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