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 |
|---|---|---|---|---|---|---|
| hand sanitizer 01 | ALCOHOL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 56a3ad5f-c34a-6b90-e063-6394a90a06e9 | 2026-07-19 | Warnings | M003 |
| Hand Sanitizer | ETHYL ALCOHOL | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56ca8257-6537-fb4e-e063-6294a90a4916 | 2026-07-17 | Warnings | M003 |
| Antibacterial Hand Sanitizer Spray. | ETHYL ALCOHOL | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56caf683-bdf1-95e6-e063-6294a90a14d0 | 2026-07-17 | Warnings | M003 |
| Hand Sanitizer | ETHYL ALCOHOL | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56cbbfcf-3239-7c76-e063-6394a90a75b0 | 2026-07-17 | Warnings | M003 |
| Hand Sanitizer | ETHYL ALCOHOL | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56cd0c67-20dd-6783-e063-6294a90ae910 | 2026-07-17 | Warnings | M003 |
| Alcohol Free Hand Sanitizer | BENZALKONIUM CHLORIDE | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56cd55ee-b8ba-ddb9-e063-6394a90a1edc | 2026-07-17 | Warnings | M003 |
| FoamyiQ Non-Alcohol Hand Sanitizer | FOAMYIQ NON-ALCOHOL HAND SANITIZER | Spartan Chemical Company | ee8a2af2-0572-19b1-e053-2995a90a23ae | 2026-07-17 | Warnings | M003 |
| Non -Alcohol Grape Scented Hand Sanitizer | BENZALKONIUM CHLORIDE | Shenzhen Lantern Scicence Co.,Ltd. | 56b5c19e-cce5-16f8-e063-6394a90a1cbd | 2026-07-16 | Warnings | M003 |
| Non -Alcohol Cherry Scented Hand Sanitizer | BENZALKONIUM CHLORIDE | Shenzhen Lantern Scicence Co.,Ltd. | 56b643ec-9433-9f19-e063-6294a90a5f22 | 2026-07-16 | Warnings | M003 |
| Non -Alcohol Blueberry scented Hand sanitizer | BENZALKONIUM CHLORIDE | Shenzhen Lantern Scicence Co.,Ltd. | 56b67ff4-5785-106e-e063-6294a90af4ec | 2026-07-16 | Warnings | M003 |
| Hand Sanitizer | ETHYL ALCOHOL | NANTONG HAIYIWEI TEXTILE CO., LTD. | 56b733b1-8a15-0767-e063-6294a90af16b | 2026-07-16 | Warnings | M003 |
| Hand sanitizer | HAND SANITIZER SPRAY | Beimei Biotechnology (Guangzhou) Co., Ltd. | 56a22363-f531-d9bd-e063-6294a90a020b | 2026-07-15 | Warnings | M003 |
| Non -Alcohol Peach Scented Hand Sanitizer | BENZALKONIUM CHLORIDE | Shenzhen Lantern Scicence Co.,Ltd. | 56b26868-833c-3d72-e063-6394a90aea4f | 2026-07-15 | Warnings | M003 |
| Hand sanitizer | HAND SANITIZER SPRAY | Beimei Biotechnology (Guangzhou) Co., Ltd. | 568f791d-d6c3-7092-e063-6294a90a4b52 | 2026-07-14 | Warnings | M003 |
| Hand sanitizer 8oz with vitamin E | ETHYL ALCOHOL 70% | REJOICE INTERNATIONAL CORP. | 03f4a507-df3f-e265-e063-6294a90acd11 | 2026-07-13 | Warnings | M003 |
| Hand sanitizer 8oz with aloe vera | ETHYL ALCOHOL 70% | REJOICE INTERNATIONAL CORP. | 03f81b63-2b08-77b1-e063-6294a90afeba | 2026-07-13 | Warnings | M003 |
| Scentfull Hand Sanitizer Pink Champagne | ALCOHOL | Scent Theory Products LLC | 565650e6-e5f9-c010-e063-6394a90aacfa | 2026-07-11 | Warnings | M003 |
| Scentfull Hand Sanitizer Blue Driftwood | ALCOHOL | Scent Theory Products LLC | 56572ebe-d624-6389-e063-6394a90a23b4 | 2026-07-11 | Warnings | M003 |
| Humco Gentian Violet 1% | GENTIAN VIOLET 1% | Humco Holding Group, Inc. | 7b4e6572-cb44-491d-8063-f7519307a8e5 | 2026-07-09 | Warnings | M003 |
| Gentian Violet 1% | GENTIAN VIOLET 1% | Pharma Nobis, LLC | e42fa7d2-47ef-0e82-e053-2995a90a67c5 | 2026-07-09 | 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 |