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 70 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL Jell Pharmaceuticals Pvt. Ltd. 3cf2ff12-0220-3307-e063-6394a90abf08 2025-08-22 Warnings Exact identifier application number: M003 Chain Drug Marketing Association, Inc. ISOPROPYL ALCOHOL Chain Drug Marketing Association Inc. 18fe4787-8986-4d64-e063-6394a90a3513 2025-08-22 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Eucalyptus Aloe ALCOHOL Scent Theory Products LLC 3cf7e175-239d-e13b-e063-6294a90a7906 2025-08-22 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Sunrise Glow ALCOHOL Scent Theory Products LLC 3cf7fce1-3112-0d66-e063-6294a90a9865 2025-08-22 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7d0e8-12b4-e410-e053-2a95a90a7f30 2025-08-21 Warnings Exact identifier application number: M003 American Red Cross 3 Hydrogen Peroxide HYDROGEN PEROXIDE MY IMPORTS USA LLC de46ffc7-3b66-dd8b-e053-2a95a90a28d8 2025-08-21 Warnings Exact identifier application number: M003 Antibacterial Hand wipes BENZALKONIUM CHLORIDE MY IMPORTS USA LLC 2ba77bab-7d02-d7c7-e063-6294a90aae87 2025-08-19 Warnings Exact identifier application number: M003 SANITIZING HAND WIPES SANITIZING HAND WIPES Jinhua Aidi Daily Chemical Co., Ltd. 3cb82a83-3067-80a6-e063-6394a90a8ab0 2025-08-19 Warnings Exact identifier application number: M003 MedPride PrepPads POVIDONE IODINE Shield Line LLC 289e92a2-f03f-4b8a-e054-00144ff8d46c 2025-08-19 Warnings Exact identifier application number: M003 I-70 Foaming ALCOHOL SANITIZER People's Janitorial Supply 3cbabb95-c72f-6984-e063-6294a90adae0 2025-08-19 Warnings Exact identifier application number: M003 Non-proprietary name ALCOHOL PREP PAD Guangzhou Four E's Scientific Co., Ltd. edaff0ca-f305-71a4-e053-2a95a90a5dca 2025-08-18 Warnings Exact identifier application number: M003 Non-proprietary name ALCOHOL PREP PAD Guangzhou Four E's Scientific Co., Ltd. edb4a43a-5b55-3404-e053-2a95a90ada27 2025-08-18 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk - SOURBET ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c9fe5a6-a729-4710-e063-6294a90a0da1 2025-08-18 Warnings Exact identifier application number: M003 Premium Hand Sanitizer with Aloe ETHANOL MCKESSON MEDICAL-SURGICAL INC. 13d42582-df02-41d5-bada-1d67c6131015 2025-08-18 Warnings Exact identifier application number: M003 MedPride Povidone Iodine Scrub Solution Skin Cleanser POVIDONE-IODINE Shield Line LLC 88dfef39-c6c2-44fc-e053-2995a90a805a 2025-08-18 Warnings Exact identifier application number: M003 MedPride Prep Solution Topical Antiseptic Microbicide POVIDONE-IODINE Shield Line LLC 88cb1b8d-3dae-be00-e053-2995a90a0d11 2025-08-18 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer 3pk - Romance Gourmond ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3caf5726-8d4c-9d36-e063-6294a90a3cf1 2025-08-18 Warnings Exact identifier application number: M003 Hand Sanitizer plus Serum Eden ALCOHOL Moam LLC 93c9f1ad-e08a-4859-bf24-db37e6b1d308 2025-08-18 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Ocean ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c9c71e5-fe7a-d342-e063-6294a90a774a 2025-08-17 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Calming Lavender ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3c76e629-96a0-7031-e063-6294a90a05ae 2025-08-16 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