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 11 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Humco Gentian Violet 2% GENTIAN VIOLET 2% Humco Holding Group, Inc. a07f61e5-0215-419a-a68a-1d814417c35f 2026-07-09 Warnings Exact identifier application number: M003 GNP Gentian Violet 1% GENTIAN VIOLET 1% Amerrisource Bergen 5d07274f-e848-6c60-e053-2991aa0a40d8 2026-07-09 Warnings Exact identifier application number: M003 Drs pharmacy triple antibiotic Pain plus itch plus Scar BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT OL PHARMA TECH, LLC 16273878-2f58-0d26-e063-6394a90a47d2 2026-07-09 Warnings Exact identifier application number: M003 Drs. Pharmacy Triple Antibiotic Plus Pain relief BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE OL PHARMA TECH, LLC Drs PHARMACY 1626fa89-cec0-6467-e063-6294a90aa2a4 2026-07-09 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical Mango ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 56148c12-7d6f-26bf-e063-6294a90a93df 2026-07-08 Warnings Exact identifier application number: M003 Povidone-Iodine POVIDONE-IODINE CARDINAL HEALTH 110, LLC. DBA LEADER 4f0d8da5-a75b-acc7-e063-6394a90ae839 2026-07-08 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical Mango ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 5600cf8a-5aba-1a22-e063-6394a90a8083 2026-07-07 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink Sugar ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 5600dc30-192d-19b1-e063-6394a90a66d3 2026-07-07 Warnings Exact identifier application number: M003 70% ISOPROPYL ALCOHOL Save-A-Lot Food Stores Ltd a592326c-c062-4ebf-b8dd-83f7e6f2f22b 2026-07-07 Warnings, Adverse reactions Exact identifier application number: M003 Amazon Basics Citrus Scent Antibacterial Hand Wipes BENZALKONIUM CHLORIDE Amazon.com Services LLC 52e5b1a4-3a84-c4cb-e063-6394a90a822c 2026-07-07 Warnings Exact identifier application number: M003 Amazon Basics Fresh Scent Antibacterial Hand Wipes BENZALKONIUM CHLORIDE Amazon.com Services LLC 5256f38a-74b6-0d18-e063-6294a90a5b46 2026-07-07 Warnings Exact identifier application number: M003 Hand Sanitizer ETHYL ALCOHOL EverywhereAire LLC b48f9e6b-c616-3607-e053-2995a90a37f5 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands hand sanitizer ETHYL ALCOHOL EverywhereAire LLC b6af3009-78c2-2312-e053-2995a90af90a 2026-07-06 Warnings Exact identifier application number: M003 Hand Sanitizer gel ALCOHOL EverywhereAire LLC d2a6c866-3f1e-20f1-e053-2995a90a26cc 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands HAND SANITIZER ETHANOL-BASED EverywhereAire LLC eab3ab67-cb27-6c2b-e053-2a95a90ace12 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands Sandalwood ETHANOL HAND SANITIZER EverywhereAire LLC 18612a10-8667-b0ef-e063-6394a90a208e 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands ETHANOL HAND SANITIZER EverywhereAire LLC b86824c2-4fae-d597-e053-2995a90ad1da 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands Lemon Olive Oil Hand Sanitizer ETHANOL HAND SANITIZER EverywhereAire LLC 42f8c2fb-a4e6-9416-e063-6294a90af9d5 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands HAND SANITIZER ETHANOL BASED EverywhereAire LLc eab52ae1-f588-b08b-e053-2995a90a96b2 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands hand sanitizer HAND SANITIZER ETHANOL-BASED EverywhereAire LLC eab19649-21fc-2fa4-e053-2995a90a90f9 2026-07-06 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