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 |
|---|---|---|---|---|---|---|
| Walgreens Hand Sanitizer Sweet Pea | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 435ca082-0b6b-c55e-e063-6294a90af56e | 2025-11-11 | Warnings | M003 |
| Smart Care Hand Sanitizer Barbie | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 435d514e-204a-118b-e063-6294a90aa8a6 | 2025-11-11 | Warnings | M003 |
| Smart Care Hand Sanitizer Spider-man | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 435d939c-9bef-bf86-e063-6394a90a4142 | 2025-11-11 | Warnings | M003 |
| Foaming Hand Sanitizer | HAND SANITIZER | American Chemical Systems II, LLC | 3085d595-68b7-4100-81c0-f0699a7609d6 | 2025-11-10 | Warnings | M003 |
| Genuine First Aid Pain Relieving Cream | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | GFA Production (Xiamen) Co., Ltd. | 48867a79-4d21-4ba1-9cf9-7839352a4b7e | 2025-11-07 | Warnings | M003 |
| Pocket Nurse | ISOPROPYL ALCOHOL | Pocket Nurse Enterprises, LLC | 42ded32e-15d9-8b03-e063-6394a90ad6bc | 2025-11-06 | Warnings | M003 |
| SMARTIES ORANGE HAND SANITIZER MIX BERRY | ALCOHOL ANTISEPTIC | Kingkey MBC Life Technology Group Co.,Ltd | 42d5785f-a86b-47fb-e063-6294a90a7314 | 2025-11-05 | Warnings | M003 |
| Sour Patch Kids Hand Sanitizer Blue Raspberry | ALCOHOL ANTISEPTIC | Kingkey MBC Life Technology Group Co.,Ltd | 42d5afab-e872-09e3-e063-6394a90abcc4 | 2025-11-05 | Warnings | M003 |
| DASIY HAND SANITIZER | ALCOHOL ANTISEPTIC | Kingkey MBC Life Technology Group Co.,Ltd | 42d632d1-17a9-b4cf-e063-6394a90a8468 | 2025-11-05 | Warnings | M003 |
| DASIY HAND SANITIZER | ALCOHOL ANTISEPTIC | Kingkey MBC Life Technology Group Co.,Ltd | 42d677a4-3cc2-a039-e063-6294a90a1672 | 2025-11-05 | Warnings | M003 |
| Pain Relieving Cleansing | BENZALKONIUM CHLORIDE, LIDOCAINE HCL | TARGET CORPORATION | 944b3f78-3efa-484b-84f0-00ffe95c5dfb | 2025-11-05 | Warnings | M003 |
| Hand Sanitizer | SDA 40B ALCOHOL 200 PROOF | Tropical Seas, Inc. | b48f9afa-1634-e63e-e053-2a95a90a32bf | 2025-11-04 | Warnings | M003 |
| Smarties Orange Hand Sanitizer Raspberry Cream | ALCOHOL ANTISEPTIC | Kingkey MBC Life Technology Group Co.,Ltd | 42d22dff-dca4-ead3-e063-6394a90abdce | 2025-11-04 | Warnings | M003 |
| Smarties Hand Sanitizer Orange Creamsicle | ALCOHOL ANTISEPTIC | Kingkey MBC Life Technology Group Co.,Ltd | 42d1fdb7-0cae-edce-e063-6294a90a9a96 | 2025-11-04 | Warnings | M003 |
| MyHealth Alcohol Antiseptic Hand Sanitizer | ALCOHOL | Aeroflex Industria de Aerosol Ltda | f8eeb819-ec48-41a4-920c-7cdae55d7ecd | 2025-10-31 | Warnings | M003 |
| MyHealth Advanced Hand Sanitizer | ALCOHOL | Aeroflex Industria de Aerosol Ltda | 0e3b2c36-57d7-438b-a2fc-fa9f00d9a552 | 2025-10-31 | Warnings | M003 |
| Nourishing Hand Sanitizer Orange Coriander | ALCOHOL SOLUTION | Noshinku | 2fed43e6-cf3a-bf33-e063-6394a90a16cf | 2025-10-31 | Warnings | M003 |
| Coralite Antibacterial Moist | BENZALKONIUM CHLORIDE | United Exchange Corp. | 6245a83f-5c81-4ae6-bc6e-adfc46c37003 | 2025-10-31 | Warnings | M003 |
| Castellani Paint | PHENOL | Stratus Pharamceuticals | 74192c0e-3c73-4ab0-96d1-1917cbd6777a | 2025-10-30 | Warnings | M003 |
| GrowDefender Antibacterial Foam | ANTIBACTERIAL FOAM | Grow Defender LLC | 423af3d9-6413-c097-e063-6294a90ae1a9 | 2025-10-28 | 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 |