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.
| 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 |
|---|---|
| BENZALKONIUM CHLORIDE | 1 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F5UM2KM3W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1111013 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1605ba44-02b7-4c72-9fec-89a5aa962b44 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68915-280-02 | 2024-04-24 | C162847 | 48780-1 | ba0f9c33-1e5c-a910-e053-dadaa90a0b85 | Eastern Century - Guardian Gel Vaginal Douche |
| 68915-280-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1e5c-a910-e053-dadaa90a0b85 | Eastern Century - Guardian Gel Vaginal Douche |
DailyMed Package Descriptions#
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Smart Care Hand Sanitizer Citrus Sunset | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 49f67a60-a6d8-0aa4-e063-6394a90a9859 | 2026-02-03 | Warnings | M003 |
| WIPES4HEALTH | BENZALKONIUM CHLORIDE | Bubble Marketing LLC | 5d6dd15b-d087-4f25-bd2b-035ecacd5f97 | 2026-02-03 | Warnings | M003 |
| Isopropyl alcohol | ISOPROPYL ALCOHOL | Concordance Healthcare Solutions, LLC | 1c051d6a-61a8-4a75-aeb6-7c1258bda2b2 | 2026-02-02 | Warnings, Adverse reactions | M003 |
| Dealmed Sterile Alcohol Prep Pads Large | ISOPROPYL ALCOHOL | Dealmed Medical Supplies, LLC. | 75908e89-abd9-4760-bd11-fb71133ae2c0 | 2026-02-02 | Warnings | M003 |
| Dealmed Sterile Alcohol Prep Pads Medium | ISOPROPYL ALCOHOL | Dealmed Medical Supplies, LLC. | 0cdfc6b4-7d66-4333-b38d-c465d4864b5c | 2026-02-02 | Warnings | M003 |
| Medline | POVIDONE-IODINE | Medline Industries, LP | 494d7e97-a3a8-2c7a-e063-6394a90a3ae1 | 2026-02-02 | Warnings | M003 |
| Aplicare | ISOPROPYL ALCOHOL | Aplicare Products, LLC | 4950e07f-36a5-b6f5-e063-6294a90a8f98 | 2026-02-02 | Warnings | M003 |
| RELEEV Cold Sore Treatment | BENZALKONIUM CHLORIDE | Merix Pharmaceutical Corp. | fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf | 2026-02-02 | Warnings | M003 |
| WISH RUBBING ALCOHOL 91% | ISOPROPYL ALCOHOL | LJ Pharma | 07cba887-a568-4b92-91ab-2e7831f24ab5 | 2026-01-30 | Warnings | M003 |
| First Aid Antiseptic | POVIDONE-IODINE | Rite Aid Corporation | 2f8abb6f-460f-47bf-811d-734126aa3f0b | 2026-01-30 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Rite Aid Corporation | c074bbaf-2fd7-485a-9e22-a368d8dd4701 | 2026-01-30 | Warnings, Adverse reactions | M003 |
| Drs. pharmacy triple antibiotic plus lidocaine | BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, LIDOCAINE OINTMENT | OL PHARMA TECH, LLC | 49a73b0f-90d9-3a4b-e063-6294a90acfb0 | 2026-01-30 | Warnings | M003 |
| HAND SANITIZER WIPES | HAND SANITIZER WIPES | Shandong Baihe Sanitary Products Co., Ltd. | 49822c99-1181-ae42-e063-6394a90a8202 | 2026-01-29 | Warnings | M003 |
| WISH RUBBING ALCOHOL 50% | ISOPROPYL ALCOHOL | LJ Pharma | 15b4a45d-3dbf-48e4-8f90-15dca7e650d9 | 2026-01-29 | Warnings | M003 |
| WISH RUBBING ALCOHOL 50% Winter Green | ISOPROPYL ALCOHOL | LJ Pharma | fbb45bde-b733-4524-bfa9-ae819ad39973 | 2026-01-29 | Warnings | M003 |
| Walmart | ISOPROPYL ALCOHOL | Walmart Inc. | 1d75799d-081e-a38b-e063-6294a90adf35 | 2026-01-29 | Warnings | M003 |
| Liquid Bandage | BENZETHONIUM CHLORIDE AND DYCLONINE HYDROCHLORIDE | Wal-Mart Stores, Inc. | f3911d79-3169-71c3-e053-2a95a90ae843 | 2026-01-29 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Amerifoods Trading Co | 38b15693-7e5f-4c85-915e-9937ea018a83 | 2026-01-29 | Warnings, Adverse reactions | M003 |
| IRIS | ISOPROPYL ALCOHOL | Amerifoods Trading Co | 100e0c3d-96eb-44af-8684-df45a8ab3065 | 2026-01-29 | Warnings, Adverse reactions | M003 |
| First Aid Antiseptic | FIRST AID ANTISEPTIC | Amerisource Bergen | 6719db46-a6e3-4f0a-828c-fe89a5187989 | 2026-01-29 | Warnings, Adverse reactions | M003 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1111013 | benzalkonium chloride 0.1 % Vaginal Gel | PSN | 1605ba44-02b7-4c72-9fec-89a5aa962b44 | 11 |
| 1111013 | benzalkonium chloride 0.001 MG/MG Vaginal Gel | SCD | 1605ba44-02b7-4c72-9fec-89a5aa962b44 | 11 |
| 1111013 | benzalkonium chloride 0.1 % Vaginal Gel | SY | 1605ba44-02b7-4c72-9fec-89a5aa962b44 | 11 |
Packages#
| 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 |