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 |
|---|---|---|---|---|---|---|
| Isopropyl alcohol | ISOPROPYL ALCOHOL | Family Dollar (FAMILY WELLNESS) | 1a3a789d-8c51-4661-84fe-df80ed70e6f1 | 2025-10-03 | Warnings | M003 |
| Equate Antibacterial Fresh Hand Wipes | BENZALKONIUM CHLORIDE | Walmart, Inc. | d2bc26d8-3e46-e479-e053-2995a90abc0a | 2025-10-01 | Warnings | M003 |
| Equate Antibacterial Wipes Fresh | BENZALKONIUM CHLORIDE | Walmart, Inc. | 21d86d5b-46ee-6ffd-e063-6394a90ab0e5 | 2025-10-01 | Warnings | M003 |
| Equate Antibacterial Wipes Citrus | BENZALKONIUM CHLORIDE | Walmart, Inc. | 2450dc1b-0c89-c92a-e063-6394a90afe22 | 2025-10-01 | Warnings | M003 |
| Equate Antibacterial Citrus Hand Wipes | BENZALKONIUM CHLORIDE | Walmart, Inc. | d2cb4c64-66fc-58e4-e053-2a95a90a7f66 | 2025-10-01 | Warnings | M003 |
| Kroger Antibacterial Hand Wipes | BENZALKONIUM CHLORIDE | The Kroger Co. | 17e29138-8c1f-e3b1-e063-6294a90a5d48 | 2025-10-01 | Warnings | M003 |
| Isopropyl alcohol | ISOPROPYL ALCOHOL | Family Dollar (FAMILY WELLNESS) | 2f1c3e24-ea71-4634-9ec1-670349b43a50 | 2025-10-01 | Warnings | M003 |
| Fresh Feels Hand Sanitizer Mist | FRESH FEELS HAND SANITIZER MIST | ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD | 3ffda86b-6b1d-8f0d-e063-6394a90aafaf | 2025-09-30 | Warnings | M003 |
| BIOPURE 50CT ANTI BACTERIAL HAND WIPES | BENZALKONIUM CHLORIDE | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | ee484505-3bb1-2989-e053-2995a90aea2b | 2025-09-30 | Warnings | M003 |
| Xpect First Aid Cream | BENZALKONIUM CHLORIDE, LIDOCAINE HCL | Cintas Corporation | f7112e5d-c8c4-42ad-8a65-24bfc32d4aea | 2025-09-30 | Warnings | M003 |
| Xpect Antiseptic Wipes | ANTISEPTIC CLEANSER | Cintas Corporation | 8f1fd933-965e-42ec-ab96-47cfe780f963 | 2025-09-29 | Warnings | M003 |
| EVR Alcohol Prep Pads | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd. | 3ffba233-6106-f633-e063-6394a90a96fe | 2025-09-29 | Warnings | M003 |
| ProHeal Alcohol Prep Pad | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd. | 3ffc0619-eb13-77af-e063-6394a90a2fd9 | 2025-09-29 | Warnings | M003 |
| ProHeal BZK Antiseptic Towelettes | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd. | 3ffc3f34-086d-1d18-e063-6294a90a71bb | 2025-09-29 | Warnings | M003 |
| First Aid Direct Alcohol Wipe | ISOPROPYL ALCOHOL | Cintas Corporation | 6a71449e-9a97-4923-8ec1-b1deb45b5746 | 2025-09-29 | Warnings | M003 |
| Northside Hospital Mothers Kit, Grey Backpack | ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE | ASP Global, LLc | 0868060e-d593-4cb2-b3d2-6c59d1ae5efc | 2025-09-29 | Warnings | M003 |
| First Aid Direct Antiseptic Wipe | BENZALKONIUM CHLORIDE | Cintas Corporation | a23f3685-7213-4cc0-97b2-588fb1224792 | 2025-09-29 | Warnings | M003 |
| Xpect Alcohol Wipes | ALCOHOL WIPES | Cintas Corporation | 51185b9a-ed6b-4a49-b524-b3ff0d5c6290 | 2025-09-29 | Warnings | M003 |
| Super-Stop BloodClotter | BLOOD CLOTTER | Cintas Corp | d910ee9b-187d-49a9-ab96-281730db2575 | 2025-09-26 | Warnings | M003 |
| Hand Sanitizer plus Holder | BENZALKONIUM CHLORIDE | Aocai Biotechnology Huizhou Co Ltd | 3fa738ce-0a04-fa11-e063-6294a90aba88 | 2025-09-25 | Warnings | 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 |