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 111 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Povidone Iodine POVIDONE IODINE GARGLE 0.5% Humco Holding Group, Inc. a7b9ad55-cfeb-6066-e053-2a95a90af975 2023-12-15 Warnings Exact identifier application number: M003 Rite Aid Povidone Iodine POVIDONE IODINE 10% Rite Aid Corporation 5df6ff37-a4ea-d666-e053-2991aa0a9786 2023-12-15 Warnings Exact identifier application number: M003 Rite Aid Decolorized Iodine ETHYL ALCOHOL Rite Aid Corporation 5e0d3664-b02a-ba28-e053-2991aa0a8a4c 2023-12-15 Warnings Exact identifier application number: M003 De La Cruz Tincture of Iodine IODINE AND SODIUM IODIDE AND ALCOHOL DLC Laboratories, Inc. 5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b 2023-12-15 Warnings Exact identifier application number: M003 ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIAL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 0c73f4f5-2b1d-84ae-e063-6394a90a5d7b 2023-12-14 Warnings Exact identifier application number: M003 TaeTu Aftercare BENZALKONIUM CHLORIDE Taetu LLC dec15a4d-1a33-a78a-e053-2995a90a69fe 2023-12-14 Warnings Exact identifier application number: M003 GNP Idoinde Tincture 2% Mild IODINE AND SODIUM IODIDE AND ALCOHOL Amerisource Bergen 32ad75b8-abd1-4151-a035-b6c9ae5fc888 2023-12-14 Warnings Exact identifier application number: M003 Antibacterial Wet Wipes BENZALKONIUM CHLORIDE HangZhou YangYi Daily Cosmetics Technology Co., Ltd. 85d3914d-dbb8-5036-e053-2a91aa0a7cd4 2023-12-13 Warnings Exact identifier application number: M003 AntiochPharma Rapidgel Hand Sanitizer ALCOHOL Weeks & Leo 0c57a9ea-de66-3ced-e063-6294a90a4b8d 2023-12-12 Warnings Exact identifier application number: M003 antiseptic hand sanitizer 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. e9f9b7b6-fed7-10e1-e053-2a95a90a9aa6 2023-12-11 Warnings Exact identifier application number: M003 AntiochPharma Hand Sanitizer ALCOHOL Weeks & Leo a1a0d368-b004-59b8-e053-2995a90ab4b1 2023-12-11 Warnings Exact identifier application number: M003 Septihol Hand Sanitizer ALCOHOL STERIS Corporation 279c5c6f-bf45-499f-a5a2-ddb535382146 2023-12-06 Warnings Exact identifier application number: M003 Zany Antiseptic Gel ALCOHOL Laboratorios Zepol S.A. ee085cb5-0ebf-498c-b622-b2c29d34bb9b 2023-12-01 Warnings Exact identifier application number: M003 Prep Pad Sterile POVIDONE-IODINE Changzhou Maokang Medical Products Co., Ltd 758abf53-ad8a-62ac-e053-2991aa0a8f0c 2023-11-15 Warnings Exact identifier application number: M003 FIRSTAR Alcohol Prep Pad ISOPROPYL ALCOHOL JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 49a86020-b888-423f-99a5-02fa938105ec 2023-11-15 Warnings Exact identifier application number: M003 CVS Health Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL CVS Health 4678074a-16f1-5480-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M003 Care One 70 Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL Ahold U.S.A., Inc. 607b6917-2880-4b1c-83c6-f1297a828ecc 2023-11-10 Warnings Exact identifier application number: M003 Topcare 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Topco Associates LLC dc4b07b6-6476-4e32-901a-da8115d6a197 2023-11-10 Warnings Exact identifier application number: M003 Topcare 70 Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL Topco Associates LLC bf9ee7da-69d9-47a2-8748-6b978ca3c298 2023-11-10 Warnings Exact identifier application number: M003 MK Alcohol Swabstick Sterile ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd 40c7cfc6-ef3b-4759-b9e9-6d7e1319a847 2023-11-09 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