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 | HAND SANITIZER SPRAY | Beimei Biotechnology (Guangzhou) Co., Ltd. | 49455156-1072-14f5-e063-6294a90abdff | 2026-01-26 | Warnings | M003 |
| Anti-bacterial Hand Wipes | ANTI-BACTERIAL HAND WIPES | Jinhua Aidi Daily Chemical Co., Ltd. | 494b09a4-4982-13bf-e063-6394a90a486f | 2026-01-26 | Warnings | M003 |
| Homworks Alcohol Wipes Multipurpose | ETHYL ALCOHOL | Acadian Crossing Consumer Products, LLC. | c9f0c3b3-5f39-dfa6-e053-2995a90a7644 | 2026-01-26 | Warnings | M003 |
| BZK Pads | BENZALKONIUM CHLORIDE | Dynarex Corporation | 87288939-cc34-4437-94ab-dcb997d6acd5 | 2026-01-23 | Warnings | M003 |
| BZK Pads | BENZALKONIUM CHLORIDE | Dynarex Corporation | 10454042-ff2e-44ce-b2e2-436cc004897f | 2026-01-23 | Warnings | M003 |
| Everlit Survival Sting Relief Pad | ISOPROPYL ALCOHOL | EVERLIT GLOBAL INC. | 3a0414ea-f862-aa0f-e063-6294a90aecb7 | 2026-01-23 | Warnings | M003 |
| Medline | POVIDONE-IODINE | Medline Industries, LP | 48ebfdd6-d346-7e26-e063-6394a90af11a | 2026-01-23 | Warnings | M003 |
| EVERLIT SURVIVAL IODINE PREP PADS | POVIDONE-IODINE | EVERLIT GLOBAL INC. | 3a03fc8d-2653-9183-e063-6294a90ad76e | 2026-01-23 | Warnings | M003 |
| EVERLIT SURVIVAL PREP PAD | ISOPROPYL ALCOHOL | EVERLIT GLOBAL INC. | 3a03ed81-5b1d-172e-e063-6394a90ac59c | 2026-01-23 | Warnings | M003 |
| Everlit Survival Antiseptic Wipe | ANTISEPTIC WIPE | EVERLIT GLOBAL INC. | 3a03f7e6-cc74-22a2-e063-6394a90a5f9f | 2026-01-23 | Warnings | M003 |
| Rite Aid Isopropyl Alcohol Wipes | ISOPROPYL ALCOHOL | Rite Aid | bca837b0-5044-4e97-e053-2a95a90a13af | 2026-01-22 | Warnings | M003 |
| Drs. Pharmacy Triple Antibiotic AND BURN RELIEF | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | OL PHARMA TECH, LLC Drs PHARMACY | 4928d9dd-542b-fe8b-e063-6294a90a9252 | 2026-01-22 | Warnings | M003 |
| DOP Ethyl Alcohol 70% | ETHYL ALCOHOL | Omega & Delta Co., Inc. | b96d85f8-739c-4b96-9dd5-8119ebf66c9f | 2026-01-21 | Warnings | M003 |
| AshleyBelle Moisturizing Hand Sanitizer Rose Lychee | ETHYL ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 48dfcbe1-8e0c-1715-e063-6394a90a733f | 2026-01-21 | Warnings | M003 |
| Lights Povindone Iodine Swabstick | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 977b6077-bf47-4e02-bde4-c752e73d7628 | 2026-01-21 | Warnings | M003 |
| Lights Povindone Iodine Scrub | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 000bf57b-1805-4746-bf1c-32856241213a | 2026-01-21 | Warnings | M003 |
| Lights Povidone Iodine Solution | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 6946eb98-6870-4b21-9dda-b01a8adab84b | 2026-01-21 | Warnings | M003 |
| Lights Povidone Iodine Prep Pad | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | e561332d-e419-43db-a68e-0c0d49b01c9a | 2026-01-21 | Warnings | M003 |
| Lights Povindone Iodine Swabstick | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 2610fde4-4572-4d15-a970-f6d3beb734fe | 2026-01-21 | Warnings | M003 |
| Lights Povidone Iodine Solution | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 7d4a92be-0601-4256-bc5b-bc1b07d97bb7 | 2026-01-21 | 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 |