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 |
|---|---|---|---|---|---|---|
| Smart Care Assorted Licensed Sanitizer Hot Wheels 01 | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 2dfdd225-24f4-6d57-e063-6394a90a8a24 | 2025-02-12 | Warnings | M003 |
| Smart Care Cucumber Melon Hand Sanitizer 01 | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 2dfe0ac7-99d5-aac3-e063-6294a90a31b3 | 2025-02-12 | Warnings | M003 |
| Isopropyl alcohol 70 percent | ISOPROPYL ALCOHOL | Good Sense (Geiss, Destin & Dunn, Inc.) | ac66be77-d358-44ea-8904-88186a7c2bbb | 2025-02-07 | Warnings | M003 |
| Rubbing Alcohol 70 Percent Isopropyl | ISOPROPYL ALCOHOL | Harris Teeter, LLC | 4196dd97-9041-4712-8196-02237a3b0cb2 | 2025-02-07 | Warnings | M003 |
| Isopropyl alcohol 91 percent | ISOPROPYL ALCOHOL | Harris Teeter, LLC | 1b044f47-45e1-40a3-81b0-2717ed425f16 | 2025-02-07 | Warnings | M003 |
| Instant Hand Sanitizer | ETHYL ALCOHOL | Rejoice International Corp. | 4e042f5b-3f0c-1830-e054-00144ff88e88 | 2025-02-06 | Warnings | M003 |
| Instant Hand Sanitizer | ETHYL ALCOHOL | Rejoice International Corp. | 4e04fa70-c25d-4499-e054-00144ff8d46c | 2025-02-06 | Warnings | M003 |
| Instant Hand Sanitizer | ETHYL ALCOHOL | Rejoice International Corp. | 4e05cceb-b8f3-48f7-e054-00144ff88e88 | 2025-02-06 | Warnings | M003 |
| Hand Sanitizer 1.8 oz Antiseptic | ETHYL ALCOHOL | REJOICE INTERNATIONAL CORP. | a0313f20-11dc-6c7d-e053-2a95a90a60f1 | 2025-02-06 | Warnings | M003 |
| Hand sanitizer 16.9oz with vitamin E | ETHYL ALCOHOL 70% | REJOICE INTERNATIONAL CORP. | 03f869b3-3004-8b25-e063-6294a90a176e | 2025-02-06 | Warnings | M003 |
| Isopropyl alcohol 70 percent Wintergreen | ISOPROPYL ALCOHOL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 444cd7f4-cf61-49b6-a93e-915d250838da | 2025-02-06 | Warnings | M003 |
| ORBIT INNOVATIONS HAND SANITIZER COTTON VANILLIA | ALCOHOL ANTISEPTIC GEL | Kingkey MBC Life Technology Group Co.,Ltd | 2d613ab9-c87b-1f3c-e063-6394a90a3120 | 2025-02-05 | Warnings | M003 |
| ORBIT INNOVATIONS HAND SANITIZER COCONUT | ALCOHOL ANTISEPTIC GEL | Kingkey MBC Life Technology Group Co.,Ltd | 2d6148e2-d959-6150-e063-6294a90acba5 | 2025-02-05 | Warnings | M003 |
| ORBIT INNOVATIONS HAND SANITIZER WATERMELON | ALCOHOL ANTISEPTIC GEL | Kingkey MBC Life Technology Group Co.,Ltd | 2d6175c9-abe5-4c68-e063-6394a90afc36 | 2025-02-05 | Warnings | M003 |
| Hand sanitizer 29ml 01 | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | eb5d6739-ee36-cd74-e053-2a95a90ab659 | 2025-02-05 | Warnings | M003 |
| Hand sanitizer 29ml 01 | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 037b4acb-49ca-bc0a-e063-6394a90a1fcc | 2025-02-05 | Warnings | M003 |
| BIOPURE 50CT ANTI BACTERIAL HAND WIPES | BENZALKONIUM CHLORIDE | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | ecef31dc-2f36-b578-e053-2995a90a3acd | 2025-02-05 | Warnings | M003 |
| Isopropyl alcohol 91 percent | ISOPROPYL ALCOHOL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 444883fc-7ae4-4dd3-bd2b-f94c3265c170 | 2025-02-05 | Warnings | M003 |
| PHARMACIST CHOICE ALCOHOL STERILE PREP PAD | ISOPROPYL ALCOHOL | Simple Diagnostics | 0fc4a4b2-342b-5948-e054-00144ff88e88 | 2025-02-04 | Warnings | M003 |
| HAND SANITIZER VANILLA | ALCOHOL ANTISEPTIC GEL | Kingkey MBC Life Technology Group Co.,Ltd | 32055326-c229-5f10-e063-6394a90ab62c | 2025-02-01 | 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 |