FDA.reportPublic FDA data

Guardian

Product NDC
68915-280
11-digit product format
689150280
Labeler code
68915
Product ID
68915-280_16e363c4-5db3-ef40-e063-6394a90a6941
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
DOUCHE
Route
VAGINAL
Labeler
Eastern Century Pharmaceuticals
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-05-23
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68915-280-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68915-280-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68915-280-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68915-280-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68915-280-028dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Guardian
Brand name suffix
Vaginal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1111013Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1605ba44-02b7-4c72-9fec-89a5aa962b44Available on FDA.report

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 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

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

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 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Unscented NasalGuard Antiseptic TopicalBENZALKONIUM CHLORIDETRUTEK CORP.eb036e11-a28c-fdc0-e053-2a95a90a9cdb2026-09-02WarningsExact identifier
application number: M003
Harris TeeterISOPROPYL ALCOHOLHarris Teeter, LLCd2bb20bd-ec83-8d80-e053-2a95a90a2bba2026-09-02WarningsExact identifier
application number: M003
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-09-02WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLTopco Associates2642298f-607e-fdca-e063-6394a90a69d92026-09-02WarningsExact identifier
application number: M003
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
application number: M003
NasalGuard Antiseptic Topical Cool MentholBENZALKONIUM CHLORIDETRUTEK CORP.e9fd3ef8-78ff-6c9f-e053-2a95a90a21a82026-09-01WarningsExact identifier
application number: M003
Maximum Strength Betadine ClearBENZALKONIUM CL AND PRAMOXINE HCLAtlantis Consumer Healthcare, Inc.31b94a76-1536-47c0-ab03-e487c2625c582026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a28101f-ea8e-6071-e063-6294a90aad912026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a3e62ce-52dc-121b-e063-6294a90a898f2026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a49db18-c270-6f46-e063-6294a90afb5d2026-08-31WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111013benzalkonium chloride 0.1 % Vaginal GelPSN1605ba44-02b7-4c72-9fec-89a5aa962b4411
1111013benzalkonium chloride 0.001 MG/MG Vaginal GelSCD1605ba44-02b7-4c72-9fec-89a5aa962b4411
1111013benzalkonium chloride 0.1 % Vaginal GelSY1605ba44-02b7-4c72-9fec-89a5aa962b4411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68915-280-01689150280015.5 mL in 1 BOTTLE5.5 mlHistorical
68915-280-02689150280021 BOTTLE in 1 BOX (68915-280-02) / 5.5 mL in 1 BOTTLE (68915-280-01) 1 bottle2011-05-23NoNoCurrent