Home NDC 68915-280 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68915-280-02 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68915-280-02 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68915-280-02 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68915-280-02 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68915-280-02 8dfbde2a14a4…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 Ingredient Strength BENZALKONIUM CHLORIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111013 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68915-280-01 GuardianVaginal 5.5 mL in 1 BOTTLE DOUCHE 5.5 11 68915-280-02 GuardianVaginal 1 in 1 BOX DOUCHE 1 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68915-280 GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS] 11 Current NDC, Legacy NDC, 2 package rows 20240426_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 27 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diabetic First Aid Gel BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Lavior Pharma Inc. bda875e6-06bd-930f-e053-2995a90ab197 2026-03-26 Warnings Exact identifier application number: M003 Povidone Iodine Prep Pad ANTISEPTIC Dynarex Corporation 81b475e8-8da4-7b15-e053-2991aa0a6629 2026-03-25 Warnings Exact identifier application number: M003 Antibacterial Hand Wipe ANTIBACTERIAL HAND WIPE Fujian Yifa Healthcare Products Co., Ltd. 4dde3373-1c75-a815-e063-6294a90aa557 2026-03-25 Warnings Exact identifier application number: M003 Los Poblanos Lavender Hand Sanitizer ALCOHOL Sombra Cosmetics Inc. 4ddef71b-f5b8-57f5-e063-6294a90a78a3 2026-03-25 Warnings Exact identifier application number: M003 palm party ALCOHOL HAND SANITIZER Dongyang Loulee Cosmetics Co.,Ltd. 48786094-aa70-d0ca-e063-6394a90acd88 2026-03-25 Warnings Exact identifier application number: M003 palm party ALCOHOL GEL Dongyang Loulee Cosmetics Co.,Ltd. 487c4724-b618-a071-e063-6394a90aa782 2026-03-25 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Bellini Glow ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe636b-f376-7e30-e063-6394a90a722b 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Coconut Lime ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe7020-e302-8706-e063-6394a90abe7c 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Island Vanilla ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe79d2-ee73-a8ed-e063-6394a90a7db5 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pink Sugar ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe8d3f-afac-cc82-e063-6294a90ae309 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Raspberry Lemonade ETHYL ALCOHOL MY IMPORTS USA LLC 4dcfcd41-b93f-accf-e063-6394a90a963d 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon Cream ETHYL ALCOHOL MY IMPORTS USA LLC 4dd00a64-c0bf-cf7d-e063-6394a90a7692 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sweet Mint Splash ETHYL ALCOHOL MY IMPORTS USA LLC 4dd010e2-7bcf-666f-e063-6294a90a4f3c 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Vanilla Swirl ETHYL ALCOHOL MY IMPORTS USA LLC 4dd01f13-5ea3-7744-e063-6294a90a124f 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Raspberry Lemonade ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4daa1aed-d763-2098-e063-6394a90a704b 2026-03-23 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon Cream ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4daa4b88-0ea3-2143-e063-6294a90a69ce 2026-03-23 Warnings Exact identifier application number: M003 povidine iodine POVIDINE IODINE Dynarex Corporation 564ec54b-353e-45a8-85e8-a39f89488d9c 2026-03-23 Warnings Exact identifier application number: M003 DURMA DynaWound Cleanser WOUND CLEANSER Dynarex Corporation 6a4dd82a-6b06-426b-9afd-415a1a4339b4 2026-03-23 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sweet Mint Splash ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4dbc68be-558b-03f0-e063-6394a90aa90d 2026-03-23 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Vanilla Swirl ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4dbc8688-f34b-1178-e063-6394a90a0e67 2026-03-23 Warnings Exact identifier application number: M003
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68915-280-01 68915028001 5.5 mL in 1 BOTTLE 5.5 ml Historical 68915-280-02 68915028002 1 BOTTLE in 1 BOX (68915-280-02) / 5.5 mL in 1 BOTTLE (68915-280-01) 1 bottle 2011-05-23 No No Current