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 |
|---|---|---|---|---|---|---|
| Walgreens Sanitizing Wipes | WALGREENS SANITIZING WIPES | Walgreens | 42de3b25-692b-eaff-e063-6294a90a0d21 | 2026-03-11 | Warnings | M003 |
| 70% Isopropyl Alcohol | ISOPROPYL ALCOHOL | Amazon.com Services LLC | 106f51fa-e687-470f-8ed8-35cb0565aeff | 2026-03-11 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Amazon.com Services LLC | 4ab76d25-136d-45e2-b9d7-964777e1d855 | 2026-03-11 | Warnings, Adverse reactions | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Perrigo Direct, Inc | 2efcda54-b8b7-4266-89c0-7f686c7afdca | 2026-03-11 | Warnings, Adverse reactions | M003 |
| Alcohol Antiseptic Pads | ISOPROPYL ALCOHOL | Acme United Corporation | 4cc307b9-aee2-3ce0-e063-6294a90aa169 | 2026-03-11 | Warnings | M003 |
| Isopropyl alcohol | ISOPROPYL ALCOHOL | Salado Sales Inc. | 30294cad-d806-4d5b-8c86-484f22d214b6 | 2026-03-10 | Warnings, Adverse reactions | M003 |
| mild iodine tincture | IODINE AND SODIUM IODINE AND ALCOHOL | KROGER COMPANY | 42762471-e5cb-505e-e063-6294a90afb7d | 2026-03-10 | Warnings | M003 |
| Numstat Antiseptic and Pain-Relieving Prep Pad | ANTISEPTIC AND PAIN-RELIEVING PREP PAD | Safetec of America Inc. | 4c9c20f2-bc17-857b-e063-6394a90a5d5c | 2026-03-09 | Warnings | M003 |
| Eco Bandage OCEAN | BENZETHONIUM CHLORIDE | ECO Bandage LLC | c7867df0-e167-4ec6-921b-6a0fb3cb0614 | 2026-03-06 | Warnings | M003 |
| Eco Bandage HONEY | BENZETHONIUM CHLORIDE | Eco Bandage LLC | d2faa027-b274-43c0-9b87-85efab89fe8e | 2026-03-06 | Warnings | M003 |
| Eco Bandage HIBISCUS | BENZETHONIUM CHLORIDE | Eco Bandage LLC | 41f8716d-a970-40cd-a29d-69dafc97def8 | 2026-03-06 | Warnings | M003 |
| Eco Bandage MOCHA | BENZETHONIUM CHLORIDE | Eco Bandage LLC | 11ec42e4-49d1-4690-80c3-784f2e30acd3 | 2026-03-06 | Warnings | M003 |
| Eco Bandage SAND | BENZETHONIUM CHLORIDE | Eco Bandage LLC | 5c620696-e8eb-445e-b746-5348ea37a214 | 2026-03-06 | Warnings | M003 |
| Eco Bandage sand ocean | BENZETHONIUM CHLORIDE | Eco Bandage LLC | da0c2d07-bc2a-4e7c-af45-f921375b52e1 | 2026-03-06 | Warnings | M003 |
| MediChoice Antiseptic Isopropyl Alcohol Prep Pads | ISOPROPYL ALCOHOL | O&M HALYARD, INC. | 20b3694e-04c7-4bca-b2ce-62ae0dec7a83 | 2026-03-05 | Warnings | M003 |
| MediChoice Alcohol Swabstick | ISOPROPYL ALCOHOL | O&M HALYARD, INC. | 7f78529d-df17-44b3-a890-1afa35308c67 | 2026-03-05 | Warnings | M003 |
| MediChoice Alcohol Prep Pads | ISOPROPYL ALCOHOL | O&M HALYARD, INC. | f4f54448-0de0-448c-9b7b-104370953ae5 | 2026-03-05 | Warnings | M003 |
| MediChoice Alcohol Swabstick | ISOPROPYL ALCOHOL | O&M HALYARD, INC. | 7cee1141-4a49-4fec-a627-91a88e3d3ffc | 2026-03-05 | Warnings | M003 |
| Loris BZK Antiseptic Wipes | BENZALKONIUM CHLORIDE | LernaPharm Loris Inc. | a448de7b-4d96-4d53-ae1a-0bd38a2fb4a2 | 2026-03-05 | Warnings | M003 |
| SPA HAND SANITIZER WRTER MELON SPLASH | ETHYL ALCOHOL | Rejoice International Corp. | 4c53620d-01ee-8ddd-e063-6294a90a8a2b | 2026-03-05 | 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 |