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… |
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 |
|---|---|---|---|---|---|---|
| Alcohol Sanitizer Spray. | ETHYL ALCOHOL | Guangdong Yanze Biotechnology Co., Ltd. | 58fb9efe-43f0-1b7f-e063-6394a90a0145 | 2026-08-14 | Warnings | M003 |
| Alcohol Hand Sanitizer | ETHYL ALCOHOL | Guangdong Yanze Biotechnology Co., Ltd. | 58fa90dc-c3b5-787b-e063-6294a90a2e17 | 2026-08-13 | Warnings | M003 |
| Isopropyl alcohol 91 percent | ISOPROPYL ALCOHOL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 961488a8-8ff3-4fa5-8846-6201e0eb5240 | 2026-08-12 | Warnings | M003 |
| LUXURY IPA 70% | LUXURY ISOPROPYL ALCOHOL 70% 16OZ | TSM BRANDS LLC | 2240a9e0-dac5-54fa-e063-6394a90a35f5 | 2026-08-11 | Warnings | M003 |
| Ethyl alcohol | ETHYL ALCOHOL | Strategic Sourcing Services LLC | 4fec6f1f-0249-423f-bd3c-427aa6924c6f | 2026-08-10 | Warnings, Adverse reactions | M003 |
| antibacterial hand wipes (JUICY WATERMELON) | ANTIBACTERIAL HAND WIPES | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 5883c43d-212b-af39-e063-6394a90ad652 | 2026-08-08 | Warnings | M003 |
| LIGHTS Antiseptic and Pain Relieving Prep Pad | ISOPROPYL ALCOHOL | Lights Medical Manufacture Co., Ltd. | 91cc7334-f610-487d-a895-3dda78c3372e | 2026-08-07 | Warnings | M003 |
| CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSK | ETHYL ALCOHOL | CVS Pharmacy, Inc. | 60128fc3-b127-44ee-9e9b-384d322d213a | 2026-08-07 | Warnings | M003 |
| CVS Beauty Hydrating Hand Sanitizer Sea Salt and Lavender | ETHYL ALCOHOL | CVS Pharmacy, Inc. | 6c160826-ad98-4390-a07b-c92a2ae5b181 | 2026-08-07 | Warnings | M003 |
| antibacterial hand wipes (2257C) | ANTIBACTERIAL HAND WIPES (2257C) | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 585a1c36-7bdc-4d4f-e063-6394a90ad6d2 | 2026-08-06 | Warnings | M003 |
| Family Beauty Antibacterial Hand Wipes | BENZALKONIUM CHLORIDE | Zhejiang Bright Care Co., Ltd. | 6ff604f7-4011-4f0e-aa2d-a46e1a973d13 | 2026-08-06 | Warnings | M003 |
| antibacterial hand wipes (Angel) | ANTIBACTERIAL HAND WIPES | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 585c4a14-8dc9-3a08-e063-6394a90ab4f5 | 2026-08-06 | Warnings | M003 |
| Hydrating Hand Sanitizer ROSEWATER SPRITZ | ALCOHOL 75% | Guangzhou Ailizhuangsi Cosmetics Co., Ltd. | 585cb4fa-6016-1550-e063-6294a90a514d | 2026-08-06 | Warnings | M003 |
| CharmTex Lightly Scented Antibacterial | BENZETHONIUM CHLORIDE | Yangzhou Jyr daily chemical Co., Ltd | 4b642dfa-f044-4410-81e4-142f0497f0f3 | 2026-08-06 | Warnings | M003 |
| antibacterial wipes 01 | BENZALKONIUM CHLORIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 585dec39-ccb8-d2ba-e063-6394a90aec0f | 2026-08-06 | Warnings | M003 |
| Hydrating Hand Sanitizer PASSION MANGO SPLASH | ALCOHOL 75% | Guangzhou Ailizhuangsi Cosmetics Co., Ltd. | 585df6ce-4625-d5d2-e063-6394a90a7fcb | 2026-08-06 | Warnings | M003 |
| Hydrating Hand Sanitizer LILY SPRINGS | ALCOHOL 75% | Guangzhou Ailizhuangsi Cosmetics Co., Ltd. | 585e0c24-7f5f-4ba7-e063-6294a90a7597 | 2026-08-06 | Warnings | M003 |
| Hydrating Hand Sanitizer WATERMELON POP | ALCOHOL 75% | Guangzhou Ailizhuangsi Cosmetics Co., Ltd. | 585e3ced-fa45-8576-e063-6294a90af50f | 2026-08-06 | Warnings | M003 |
| Hydrating Hand Sanitizer ALOE BREEZE | ALCOHOL 75% | Guangzhou Ailizhuangsi Cosmetics Co., Ltd. | 585e647c-2904-2d3f-e063-6394a90a2b79 | 2026-08-06 | Warnings | M003 |
| Hydrating Hand Sanitizer LAVENDER DREAM | ALCOHOL 75% | Guangzhou Ailizhuangsi Cosmetics Co., Ltd. | 585e8222-fad5-4409-e063-6394a90a9c60 | 2026-08-06 | 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 |