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 110 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sunmark Hydrogen Peroxide 3 Percent HYDROGEN PEROXIDE Strategic Sourcing Services LLC c79ae066-8b3b-400d-8b26-f41100e7f534 2023-12-19 Warnings Exact identifier application number: M003 Sunmark Iodides Tincture ETHYL ALCOHOL Strategic Sourcing Services LLC 5e227f79-fca7-4633-97ea-61da4060fe92 2023-12-19 Warnings Exact identifier application number: M003 sunmark Povidone-Iodine Topical POVIDONE-IODINE Strategic Sourcing Services LLC acc349d6-2875-4814-aa6e-828fffec7f07 2023-12-19 Warnings Exact identifier application number: M003 DDM Iodine Tincture Mild IODINE AND SODIUM IODIDE AND ALCOHOL Discount Drug Mart 5d538c8e-bf87-d85c-e053-2991aa0af729 2023-12-19 Warnings Exact identifier application number: M003 DDM Decolorized Iodine ETHYL ALCOHOL Discount Drug Mart 5d570ea7-ab08-54b7-e053-2991aa0a7a83 2023-12-19 Warnings Exact identifier application number: M003 DDM Povidone Iodine POVIDONE IODINE 10% Discount Drug Mart 5d161a9d-0462-0afd-e053-2991aa0a22e2 2023-12-19 Warnings Exact identifier application number: M003 HEB Povidone Iodine POVIDONE IODINE 10% H E B 5d576ce2-7d63-c860-e053-2a91aa0a072c 2023-12-18 Warnings Exact identifier application number: M003 Publix Povidone Iodine POVIDONE IODINE 10% Publix 5d6bba46-2571-4957-e053-2a91aa0a2e85 2023-12-18 Warnings Exact identifier application number: M003 Top Care Decolorized Iodine ETHYL ALCOHOL TOPCO ASSOCIATES LLC 5d6bdc17-5c3a-7dec-e053-2991aa0aa450 2023-12-18 Warnings Exact identifier application number: M003 Tincture Merthiolate BENZALKONIUM CHLORIDE DLC Laboratories, Inc 4fec9119-fbbf-4fc7-9122-c6300cac8731 2023-12-18 Warnings Exact identifier application number: M003 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL New Pride Corp 0c9e1e9c-b8fc-1932-e063-6394a90a09bf 2023-12-16 Warnings Exact identifier application number: M003 DermaWound Wound Care POVIDONE-IODINE Progressive Doctors, LLC 2d49daa7-aa02-4219-880b-e1697bde8a7e 2023-12-15 Warnings Exact identifier application number: M003 Ethyl Rubbing Alcohol ALCOHOL Humco Holding Group, Inc. 829f3e16-7a9b-4da7-87d2-f58254bda721 2023-12-15 Warnings Exact identifier application number: M003 Humco Iodides Tincture ETHYL ALCOHOL Humco Holding Group, Inc. d230e3a2-1cde-44a9-82c3-3dc5474b3a72 2023-12-15 Warnings Exact identifier application number: M003 Humco Hydrogen Peroxide HYDROGEN PEROXIDE 3% Humco Holding Group, Inc. 2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Humco Holding Group, Inc. c220b916-6914-435f-84e2-ba828c9916b1 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Isopropyl Rubbing Alcohol 70% Professional Pack ISOPROPYL ALCOHOL Humco Holding Group, Inc. 8de61fdd-8bb9-4845-9129-97bed0686a68 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Merthiolate BENZALKONIUM CHLORIDE Humco Holding Group, Inc. 864063a5-c6cc-4657-9cd6-51af4673bf98 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE SPRAY 5% Humco Holding Group, Inc. a7bb80c4-bbc0-21ea-e053-2995a90a52c1 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE 10% Humco Holding Group, Inc. 6064c23b-7c15-208d-e053-2991aa0a00f6 2023-12-15 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