Guardelle
- Product NDC
- 85754-000
- 11-digit product format
- 857540000
- Labeler code
- 85754
- Product ID
- 85754-000_3a8774ed-4fdf-48b6-a54b-8db85492cb34
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BENZALKONIUM CHLORIDE
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Social Medical Supply LLC
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-16
- Substance
- BENZALKONIUM CHLORIDE
- Active strength
- .13 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- Guardelle
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZALKONIUM CHLORIDE | .13 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F5UM2KM3W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1020365 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8793e3be-7409-4f71-9397-abbeacd27cf8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85754-000-02 | Guardelle | 52 mL in 1 BOTTLE, PUMP | AEROSOL, FOAM | 52 | 1 | |
| 85754-000-07 | Guardelle | 207 mL in 1 BOTTLE, PUMP | AEROSOL, FOAM | 207 | 1 | |
| 85754-000-18 | Guardelle | 500 mL in 1 BOTTLE, PUMP | AEROSOL, FOAM | 500 | 1 |
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 |
|---|---|---|---|---|
| 1020365 | benzalkonium chloride 0.13 % Topical Foam | PSN | 8793e3be-7409-4f71-9397-abbeacd27cf8 | 1 |
| 1020365 | benzalkonium chloride 1.3 MG/ML Topical Foam | SCD | 8793e3be-7409-4f71-9397-abbeacd27cf8 | 1 |
| 1020365 | benzalkonium chloride 0.13 % Topical Foam | SY | 8793e3be-7409-4f71-9397-abbeacd27cf8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85754-000-02 | 85754000002 | 52 mL in 1 BOTTLE, PUMP (85754-000-02) | 52 ml | 2025-10-16 | No | No | Current |
| 85754-000-07 | 85754000007 | 207 mL in 1 BOTTLE, PUMP (85754-000-07) | 207 ml | 2025-10-16 | No | No | Current |
| 85754-000-18 | 85754000018 | 500 mL in 1 BOTTLE, PUMP (85754-000-18) | 500 ml | 2025-10-16 | No | No | Current |