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 |
|---|---|---|---|---|---|---|
| Alcohol sterile | ISOPROPYL ALCOHOL | Cardinal Health, Inc | bb7c530f-5d80-4158-b715-09c1c837299d | 2024-11-21 | Warnings | M003 |
| Alcohol sterile | ISOPROPYL ALCOHOL | Cardinal Health 200 LLC | 10135db9-f614-4511-96ac-faa6a02a1b61 | 2024-11-21 | Warnings | M003 |
| BZK Antiseptic Swabsticks 4 Triple | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd | d9f35c14-2f5a-4e1a-bc2b-a7e163134213 | 2024-11-21 | Warnings | M003 |
| Povidone-lodine Swabsticks Triple | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 74e70ea9-640b-4295-a40f-56f65fca1300 | 2024-11-21 | Warnings | M003 |
| MK Alcohol Prep Pads Medium | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd | 37f10b1f-b73c-4d71-91c2-1252f3d9d4ce | 2024-11-21 | Warnings | M003 |
| BZK Antiseptic Towelette | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd | 1936d749-bf38-a433-e063-6294a90aba8c | 2024-11-21 | Warnings | M003 |
| Maokang 10 Povidone Iodine | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 7c17ce40-0358-44ff-aa60-53711666914b | 2024-11-21 | Warnings | M003 |
| MK Alcohol Prep Pads Medium | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd | 11390854-9e72-40a2-9c89-3c29a585dced | 2024-11-21 | Warnings | M003 |
| Instant Hand Sanitizeing Wipe | ISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTS | Shandong Yayun Sanitary Products Co., Ltd. | aa0dc01a-2c6b-7402-e053-2a95a90af6a2 | 2024-11-21 | Warnings | M003 |
| Dynarex Povidone Iodine Prep Solution | POVIDONE IODINE PREP SOLUTION | Dynarex Corporation | 6bb4d55b-2be7-3549-e053-2a91aa0a2bb0 | 2024-11-20 | Warnings | M003 |
| Dynarex Povidone Iodine Surgical Scrub | POVIDONE IODINE SURGICAL SCRUB SOLUTION | Dynarex Corporation | 6f053e55-cbf6-9072-e053-2991aa0a2edd | 2024-11-20 | Warnings | M003 |
| Dynarex Green | ALCOHOL | Dynarex Corporation | 072572be-49dd-4594-bc40-b56db57ada5b | 2024-11-20 | Warnings | M003 |
| Dynarex Green | CHLOROXYLENOL | Dynarex Corporation | 59b098d2-08de-4fdb-a209-ae226abf37d6 | 2024-11-20 | Warnings | M003 |
| Baby Wipes | PROPYLENE GLYCOL | Shandong Yayun Sanitary Products Co., Ltd. | aeb9a12c-955f-5030-e053-2995a90a2dd6 | 2024-11-20 | Warnings | M003 |
| Pet wipes | BENZALKONIUM CHLORIDE | Shandong Yayun Sanitary Products Co., Ltd. | 2764ea79-32d8-b7f6-e063-6394a90a5501 | 2024-11-20 | Warnings | M003 |
| Premium Hand Sanitizer | ETHANOL | MCKESSON MEDICAL-SURGICAL INC. | a9514466-e0c6-4792-984a-9f07d94ee887 | 2024-11-18 | Warnings | M003 |
| MARVEL BZK ANTISEPTIC WIPE | BENZALKONIUM CHLORIDE | Ashtel Studios, Inc. | 93ed0bb4-834d-44ca-9c0a-20086fc09ab8 | 2024-11-18 | Warnings | M003 |
| Isopropyl Rubbing Alcohol | ISOPROPYL ALCOHOL | McKesson Medical-Surgical Inc. | 98b0bcc2-539b-4471-ba98-bbe17bb881bd | 2024-11-15 | Warnings | M003 |
| CVS Health Hydrogen Peroxide Wipes | HYDROGEN PEROXIDE | CVS PHARMACY, INC | 7a930a5e-5b69-428f-9cbb-d03dae180295 | 2024-11-12 | Warnings | M003 |
| First Aid Only Povidone-Iodine Prep Pad | POVIDONE-IODINE | Acme United Corporation | 509b6c8e-6a9f-2656-e054-00144ff8d46c | 2024-11-09 | 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 |