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 |
|---|---|---|---|---|---|---|
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Topco Associates LLC | be4f41bd-8a75-4fb6-8d28-67f6f853e6bd | 2026-02-11 | Warnings, Adverse reactions | M003 |
| 70% Isopropyl Rubbing Alcohol | ISOPROPYL RUBBING ALCOHOL | Topco Associates LLC | 9fbded5f-8dc1-4134-a711-48d1a581d874 | 2026-02-11 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Topco Associates LLC | ad1ef2ea-bfc3-4a8a-acd2-55e7f52813d4 | 2026-02-11 | Warnings, Adverse reactions | M003 |
| Antibacterial Wet wipes | BENZALKONIUM CHLORIDE | Zhejiang Easyclean Daily Chemical Co., Ltd. | a1cb6ac9-95f5-3ef1-e053-2a95a90abcdf | 2026-02-11 | Warnings | M003 |
| Universal ISOPROPYL Rubbing Alcohol 70% | ISOPROPYL ALCOHOL | Universal Distribution Center LLC | 0c76f14b-9a0c-4573-96f2-cd4080eb99e6 | 2026-02-10 | Warnings | M003 |
| Ethyl Rubbing Alcohol | ETHYL ALCOHOL | Walgreen Co. | a08ef11f-5c4f-4821-a0c0-d6c89def0bea | 2026-02-10 | Warnings, Adverse reactions | M003 |
| 70% | ISOPROPYL ALCOHOL | Walgreen Co. | fb918e7a-1fe0-4cfd-8cf0-9d823eb56dcc | 2026-02-10 | Warnings, Adverse reactions | M003 |
| AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAM | BENZALKONIUM CL 0.13% V/V | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 49e31509-d489-44be-e063-6394a90a97ef | 2026-02-10 | Warnings | M003 |
| AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAM | BENZALKONIUM CL 0.13% V/V | MY IMPORTS USA LLC | 4a849c4f-9b96-6b20-e063-6394a90a3486 | 2026-02-10 | Warnings | M003 |
| Medline | ISOPROPYL ALCOHOL | Hy-Vee, Inc. | 4bbce274-1e62-0c6a-e063-6394a90af92f | 2026-02-10 | Warnings | M003 |
| Everlit Care Products Antiseptic Wipe | ANTISEPTIC WIPE | EVERLIT GLOBAL INC. | 3331e2f1-c3d0-41fc-a792-be5dcdf4e24a | 2026-02-09 | Warnings | M003 |
| EVERLIT CARE PRODUCTS PREP PAD | ISOPROPYL ALCOHOL | EVERLIT GLOBAL INC. | 77a60360-8bb5-43e9-b7e4-f71d2d488c44 | 2026-02-09 | Warnings | M003 |
| Everlit Care Products Sting Relief | ISOPROPYL ALCOHOL | EVERLIT GLOBAL INC. | adfab206-b7de-4f6a-a864-edd946ea743d | 2026-02-09 | Warnings | M003 |
| EVERLIT CARE PRODUCTS IODINE PREP PAD | POVIDONE-IODINE | EVERLIT GLOBAL INC. | 5cbdb73d-333a-4244-a1c0-be430632f0ed | 2026-02-09 | Warnings | M003 |
| Alcohol | ISOPROPYL ALCOHOL | A-S Medication Solutions | 6b8834be-0235-4f7c-8d52-c2f6aa2d3049 | 2026-02-08 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Salado Sales Inc. | 78a46975-568a-4a88-8597-9603b8bbf935 | 2026-02-06 | Warnings, Adverse reactions | M003 |
| 70% Rubbing | ISOPROPYL ALCOHOL | Walgreens Co. | 6ad37d18-5c19-4b5f-8313-edd430f84fb0 | 2026-02-05 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Walgreens Co. | 1473e6e4-dc5f-43d9-a249-111a181e3f76 | 2026-02-05 | Warnings, Adverse reactions | M003 |
| Aquarrelle Antibacterial Wipes 40 | BENZALKONIUM CHLORIDE | Kimberly-Clark De Mexico, S.A.B.deC.V. | 3584680e-71b0-23b6-e063-6294a90a6998 | 2026-02-05 | Warnings | M003 |
| Aquarrelle Antibacterial Wipes 20 | BENZALKONIUM CHLORIDE | Kimberly-Clark De Mexico, S.A.B.deC.V. | 35865d33-a99f-1b37-e063-6394a90a00d2 | 2026-02-05 | 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 |