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 104 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nourishing Hand Sanitizer Limon ALCOHOL Noshinku d70fba7a-513f-0341-e053-2a95a90add86 2024-05-15 Warnings Exact identifier application number: M003 Nourishing Hand Sanitizer Vetiver ALCOHOL Noshinku d70fb84c-fdbc-6ba8-e053-2995a90ab529 2024-05-15 Warnings Exact identifier application number: M003 Safly BZK Antiseptic Towelette BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 5cd9043e-daf2-43eb-9568-54775fc4f84a 2024-05-15 Warnings Exact identifier application number: M003 Noshinku Bergamot Hand Sanitizer ALCOHOL Noshinku 53fea81e-4482-6fae-e054-00144ff8d46c 2024-05-14 Warnings Exact identifier application number: M003 Noshinku Eucalyptus Hand Sanitizer ALCOHOL Noshinku 9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c0 2024-05-14 Warnings Exact identifier application number: M003 Noshinku Lavender Hand Sanitizer ALCOHOL Noshinku a57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf 2024-05-14 Warnings Exact identifier application number: M003 LEADER 2% Mild Iodine Tincture IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID Cardinal Health, 110 dba Leader 7f810b92-60f6-2f72-e053-2991aa0ab973 2024-05-13 Warnings Exact identifier application number: M003 Leader Decolorized Iodine ALCOHOL LIQUID Cardinal Health, 110 dba Leader 822f6f28-956f-dd82-e053-2991aa0ae752 2024-05-13 Warnings Exact identifier application number: M003 Inverness Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a2995-334c-2e93-e063-6294a90aecf7 2024-05-09 Warnings Exact identifier application number: M003 Helzberg Diamonds Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a3776-0edd-26f3-e063-6294a90a740d 2024-05-09 Warnings Exact identifier application number: M003 Ulta Beauty Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a37f4-8718-3e40-e063-6294a90acaad 2024-05-09 Warnings Exact identifier application number: M003 Guardian Vaginal BENZALKONIUM CHLORIDE Eastern Century Pharmaceuticals 1605ba44-02b7-4c72-9fec-89a5aa962b44 2024-04-24 Warnings Exact identifier application number: M003 ndc (product): 68915-280 Inverness Hygienic Ear Care Antiseptic BENZALKONIUM CHLORIDE The Richline Group, Inc. 0ccd72e7-16a2-47c7-9ce6-dffb63a0344b 2024-04-18 Warnings Exact identifier application number: M003 Lovisa Piercing Care Solution BENZALKONIUM CHLORIDE The Richline Group, Inc. 74f46b81-cc5b-4e3f-a36e-0bd86d370c22 2024-04-18 Warnings Exact identifier application number: M003 CliniClean BZK Cleansing Contains Benzalkonium Chloride BENZALKONIUM CHLORIDE HR HealthCare b6916466-0931-408f-a430-0797a449c32e 2024-04-18 Warnings Exact identifier application number: M003 Handy Solutions First Aid Kit BENZALKONIUM CHLORIDE Navajo Manufacturing Company Inc. 130237ff-3db4-1288-e063-6394a90ab1af 2024-04-16 Warnings Exact identifier application number: M003 BZK BENZALKONIUM CHLORIDE Henry Schein Inc. ff877b63-fa58-4770-a882-694eda33203b 2024-04-02 Warnings Exact identifier application number: M003 First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE M-star (Hubei) Health&Care Products Co., Ltd. 8e1f35ff-d4e6-4940-ad8f-dce2b73e595d 2024-04-01 Warnings Exact identifier application number: M003 Antiseptic Towelette TOALLITAS ANTISEPTICAS BENZALKONIUM CHLORIDE M-star (Hubei) Health&Care Products Co., Ltd. b267e186-cf7a-458f-9c28-a48a8554af40 2024-04-01 Warnings Exact identifier application number: M003 Antiseptic Povidone Iodine Prep Pad POVIDONE-IODINE M-star (Hubei) Health&Care Products Co., Ltd. fc76c1f3-b48e-4276-890d-5b8e5a894e62 2024-04-01 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