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 Luxury Hand Sanitizer Cashmere Char | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 41938c11-391c-0a55-e063-6394a90ad451 | 2025-10-20 | Warnings | M003 |
| Smart Care Luxury Hand Sanitizer Tea and Timber | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 4193d08a-bc54-ef3b-e063-6294a90a0608 | 2025-10-20 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Coastal Coconut | ETHYL ALCOHOL 70% V/V | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 41940273-689d-0f44-e063-6294a90a957f | 2025-10-20 | Warnings | M003 |
| Smart Care Luxury Hand Sanitizer Vanilla Verdant | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 41942841-faa9-114e-e063-6294a90a0e58 | 2025-10-20 | Warnings | M003 |
| Smart Care Luxury Hand Sanitizer Zen and Zest | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 419441a8-a6df-e15d-e063-6294a90a02ae | 2025-10-20 | Warnings | M003 |
| CVS Alcohol Prep | ISOPROPYL ALCOHOL | CVS Pharmacy | 7abc66f2-faf6-421c-9c3c-b69f5a587246 | 2025-10-20 | Warnings | M003 |
| Gentian Violet | GENTIAN VIOLET | World Perfumes Inc | 419cc9a2-bfde-a516-e063-6294a90a065c | 2025-10-20 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Lavender Drift | ETHYL ALCOHOL 70% V/V | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 41a2d051-4920-76ee-e063-6294a90a5d3c | 2025-10-20 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Peach Nectar | ETHYL ALCOHOL 70% V/V | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 41a36bb3-a648-3b5b-e063-6394a90aa4df | 2025-10-20 | Warnings | M003 |
| PROHEAL ALCOHOL XXL PREP PADS | ISOPROPYL ALCOHOL | Click Industries LLC | ec81be59-94a5-4675-9047-e3e82d7ad761 | 2025-10-20 | Warnings | M003 |
| ALCOHOL PREP PAD | ISOPROPYL ALCOHOL | Guangdong Comfort Medical Products Co., Ltd. | 3a2dea43-8123-3fb7-e063-6294a90a5e50 | 2025-10-19 | Warnings | M003 |
| ANTISEPTIC WIPE | BENZALKONIUM CHLORIDE | Guangdong Comfort Medical Products Co., Ltd. | 3a40a31d-4032-71ba-e063-6294a90a48dc | 2025-10-19 | Warnings | M003 |
| ANTIBACTERIAL BANDAGES | BENZALKONIUM CHLORIDE | Guangdong Comfort Medical Products Co., Ltd. | 6e43b8b3-2d49-8f76-e053-2a91aa0affb0 | 2025-10-19 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Soft Berry | ETHYL ALCOHOL 70% V/V | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 418fed84-d4ab-7352-e063-6294a90a6dab | 2025-10-19 | Warnings | M003 |
| BZK CLEANSER | BENZALKONIUM CHLORIDE | Geri-Gentle Corporation | 415eb5fb-5f88-d2dd-e063-6394a90abe5d | 2025-10-17 | Warnings | M003 |
| Medline Alcohol Prep Sterile, Large | ISOPROPYL ALCOHOL | Medline Industries, LP | c9fae7b6-2f4b-490b-9b17-a7297e738069 | 2025-10-16 | Warnings | M003 |
| Medline Alcohol Prep Sterile, Medium | ISOPROPYL ALCOHOL | Medline Industries, LP | 9a8584e1-b422-4b77-8464-4e022d578fad | 2025-10-16 | Warnings | M003 |
| Signature Select Pain Relieving | LIDOCAINE HCL, BENZALKONIUM CHLORIDE | Safeway/Albartsons | 3cab1b0c-4ffd-9c01-e063-6294a90ad15d | 2025-10-16 | Warnings | M003 |
| Medline Alcohol Prep | ISOPROPYL ALCOHOL | Medline Industries, LP | b43c0bff-82f8-c18d-e053-2995a90a8716 | 2025-10-16 | Warnings | M003 |
| Medline | BENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDE | Medline Industries, LP | b1059e68-b240-056c-e053-2995a90a61b2 | 2025-10-16 | 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 |