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 |
|---|---|---|---|---|---|---|
| Olimpo Antibacterial | BENZALKONIUM CHLORIDE 0.1% | Industria La Popular, S.A. | 597e3b3e-51f0-5fcf-e063-6394a90ac297 | 2026-08-20 | Warnings | M003 |
| Benzalkonium Chloride | BENZALKONIUM CHLORIDE TOWELETTES | Trifecta Pharmaceuticals USA LLC | 59811e67-57f0-4db1-e063-6294a90a2ad8 | 2026-08-20 | Warnings | M003 |
| inControl alcohol | ISOPROPYL ALCOHOL | H-E-B | 45dfbd7a-0ae1-4146-9527-5483c884e636 | 2026-08-18 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | The Kroger Co. | 52f6258f-4b4c-49f4-9bc7-40dc3918869d | 2026-08-17 | Warnings, Adverse reactions | M003 |
| 70% Isopropyl Rubbing Alcohol | ISOPROPYL RUBBING ALCOHOL | The Kroger Co. | b127bba1-ce0b-4142-8b7d-f12f062b0938 | 2026-08-17 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | The Kroger Co. | cd3f8779-9e57-4b23-a029-7424d4d4ab2a | 2026-08-17 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | The Kroger Co. | ca6c7f8a-d41a-4d77-817c-3dbdc40f890e | 2026-08-17 | Warnings, Adverse reactions | M003 |
| Alcohol Sanitizer Spray. | ETHYL ALCOHOL | Guangdong Yanze Biotechnology Co., Ltd. | 58fb9efe-43f0-1b7f-e063-6394a90a0145 | 2026-08-14 | Warnings | M003 |
| Povidone-Iodine | POVIDONE-IODINE | Major Pharmaceuticals | 59041ca3-a195-5a20-e063-6394a90a2ac9 | 2026-08-14 | Warnings | M003 |
| Alcohol Hand Sanitizer | ETHYL ALCOHOL | Guangdong Yanze Biotechnology Co., Ltd. | 58fa90dc-c3b5-787b-e063-6294a90a2e17 | 2026-08-13 | Warnings | M003 |
| SprinJene | ALCOHOL | Health and Natural Beauty USA Corp | 1853f023-f4db-4cd8-a4df-a439bc306cc3 | 2026-08-13 | Warnings | M003 |
| LUXURY IPA 70% | LUXURY ISOPROPYL ALCOHOL 70% 16OZ | TSM BRANDS LLC | 2240a9e0-dac5-54fa-e063-6394a90a35f5 | 2026-08-11 | Warnings | M003 |
| Ethyl alcohol | ETHYL ALCOHOL | Strategic Sourcing Services LLC | 4fec6f1f-0249-423f-bd3c-427aa6924c6f | 2026-08-10 | Warnings, Adverse reactions | M003 |
| antibacterial hand wipes (JUICY WATERMELON) | ANTIBACTERIAL HAND WIPES | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 5883c43d-212b-af39-e063-6394a90ad652 | 2026-08-08 | Warnings | M003 |
| LIGHTS Antiseptic and Pain Relieving Prep Pad | ISOPROPYL ALCOHOL | Lights Medical Manufacture Co., Ltd. | 91cc7334-f610-487d-a895-3dda78c3372e | 2026-08-07 | Warnings | M003 |
| CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSK | ETHYL ALCOHOL | CVS Pharmacy, Inc. | 60128fc3-b127-44ee-9e9b-384d322d213a | 2026-08-07 | Warnings | M003 |
| CVS Beauty Hydrating Hand Sanitizer Sea Salt and Lavender | ETHYL ALCOHOL | CVS Pharmacy, Inc. | 6c160826-ad98-4390-a07b-c92a2ae5b181 | 2026-08-07 | Warnings | M003 |
| antibacterial hand wipes (2257C) | ANTIBACTERIAL HAND WIPES (2257C) | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 585a1c36-7bdc-4d4f-e063-6394a90ad6d2 | 2026-08-06 | Warnings | M003 |
| antibacterial hand wipes (Angel) | ANTIBACTERIAL HAND WIPES | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 585c4a14-8dc9-3a08-e063-6394a90ab4f5 | 2026-08-06 | Warnings | M003 |
| Hydrating Hand Sanitizer ROSEWATER SPRITZ | ALCOHOL 75% | Guangzhou Ailizhuangsi Cosmetics Co., Ltd. | 585cb4fa-6016-1550-e063-6294a90a514d | 2026-08-06 | 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 |