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 105 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Novex Hand Sanitizer BENZALKONIUM CHLORIDE Natural Essentials, Inc. 8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3 2024-03-20 Warnings Exact identifier application number: M003 Antiseptic BENZALKONIUM CHLORIDE 0.13% Trifecta Pharmaceuticals USA, LLC. 13f1c70f-3b44-8eef-e063-6294a90af634 2024-03-18 Warnings Exact identifier application number: M003 Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCI Trifecta Pharmaceuticals USA LLC 1308ce91-2858-310a-e063-6394a90a6810 2024-03-06 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Cocoa Butter ETHYL ALCOHOL Rejoice International, Inc. 97dee45e-53be-4b37-a427-fc24388c0e05 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer Aloe Vera ETHYL ALCOHOL Rejoice International, Inc. 1e28454c-f5d8-4d6e-91f9-bc4501b027c1 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Clear ETHYL ALCOHOL Rejoice International, Inc. f0e637d9-d61e-466d-9e05-f906639dbaca 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International, Inc. 07b163e4-8f67-44e7-b5ef-f237023080e0 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Ice Clear ETHYL ALCOHOL Rejoice International, Inc. 605ec88a-2f4c-4716-8522-eb2748b43398 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Original ETHYL ALCOHOL Rejoice International, Inc. bb9cc886-275e-4996-99dc-529f928b4905 2024-02-28 Warnings Exact identifier application number: M003 Liquid Hand Cleanse TRICLOSAN Rejoice International, Inc. 23ff5450-8308-41c0-9052-1ac4c4433d6c 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Antibacterial Hand Cleanse Original TRICLOSAN Rejoice International, Inc. b5ce6663-fe82-4da1-923e-acea293d7a00 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate TRICLOSAN Rejoice International, Inc. b68a7d64-2650-4fc6-a89e-05de9098a2a3 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Antibacterial Hand Cleanse Mountain Spring TRICLOSAN Rejoice International, Inc. c31723d5-a313-448a-8b69-ca5f8dec25ed 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom BENZALKONIUM CHLORIDE Rejoice International a9a1467c-abcc-4ccb-88f6-430279609788 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom BENZALKONIUM CHLORIDE Rejoice International 9fa9d955-7167-4a0a-935b-2a600f439eb0 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower BENZALKONIUM CHLORIDE Rejoice International 157a14bf-f46e-49f8-96f4-a6c472eb5cb8 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foaming Hand Sanitizer BENZALKONIUM CHLORIDE Rejoice International 3082cbbb-a0ed-45eb-a116-ad1c65357dd1 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast BENZALKONIUM CHLORIDE Rejoice International 45b3ca49-edb4-4840-b857-d24045494a3a 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower BENZALKONIUM CHLORIDE Rejoice International 4890f81e-7994-4ea2-9412-5614c405a2a3 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Wild Berry Blast BENZALKONIUM CHLORIDE Rejoice International 5c109f7c-1f4d-484a-b6ea-3bbcf572bbac 2024-02-28 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