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 |
|---|---|---|---|---|---|---|
| Walmart | ISOPROPYL ALCOHOL | Walmart, Inc. | 2eff98ba-5736-b07e-e063-6394a90aeea9 | 2026-09-04 | Warnings | M003 |
| Walgreen Alcohol | ISOPROPYL ALCOHOL | Walgreens Company | deeae1ea-3d81-4260-95be-c4f328e3fdef | 2026-09-04 | Warnings | M003 |
| Dollar General | ISOPROPYL ALCOHOL | Dollar General Corporation | 00b2ef34-42d9-523c-e063-6294a90a753d | 2026-09-03 | Warnings | M003 |
| Signature Select Alcohol Prep Pads | ISOPROPYL ALCOHOL | Better Living Brands LLC | 31ce72e3-03a3-1608-e063-6394a90ad850 | 2026-09-03 | Warnings | M003 |
| SurviveX Sting Relief | STING RELIEF WIPE | Changzhou Maokang Medical Products Co., Ltd. | 5a83b1f1-c8dc-cf07-e063-6394a90a20ca | 2026-09-03 | Warnings | M003 |
| Benzethonium chloride Plus Dyclonine hydrochloride | LIQUID BANDAGE | Kroger Co. | fe604470-917f-4cbd-a1e6-ac1dc7c57ff6 | 2026-09-02 | Warnings | M003 |
| Alcohol | ISOPROPYL ALCOHOL | Rite Aid Corporation | 5104f9ab-0b28-449f-a55a-5438713a24df | 2026-09-02 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | UpLift Brands, LLC | 5a81b635-d188-0b29-e063-6294a90a1e4b | 2026-09-02 | Warnings, Adverse reactions | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | CVS Pharmacy, Inc. | 7f518646-c8fe-499a-b5e4-8e5a5a90e01d | 2026-09-02 | Warnings, Adverse reactions | M003 |
| Alcohol | ISOPROPYL ALCOHOL | The Kroger Company | 6551187f-5cde-4149-931f-b057bd760750 | 2026-09-02 | Warnings | M003 |
| Unscented NasalGuard Antiseptic Topical | BENZALKONIUM CHLORIDE | TRUTEK CORP. | eb036e11-a28c-fdc0-e053-2a95a90a9cdb | 2026-09-02 | Warnings | M003 |
| Harris Teeter | ISOPROPYL ALCOHOL | Harris Teeter, LLC | d2bb20bd-ec83-8d80-e053-2a95a90a2bba | 2026-09-02 | Warnings | M003 |
| School Health | ISOPROPYL ALCOHOL | School Health Corporation | db5d0b22-f2d7-23e5-e053-2a95a90aeb51 | 2026-09-02 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Topco Associates | 2642298f-607e-fdca-e063-6394a90a69d9 | 2026-09-02 | Warnings | M003 |
| HUSTLE BUTTER NUMBING | LIDOCAINE HCL, BENZALKONIUM CHLORIDE | H.B.D. DIST. INC. | 5b4d0390-dac6-4a71-9fdc-5c31543e7c5a | 2026-09-02 | Warnings | M003 |
| NasalGuard Antiseptic Topical Cool Menthol | BENZALKONIUM CHLORIDE | TRUTEK CORP. | e9fd3ef8-78ff-6c9f-e053-2a95a90a21a8 | 2026-09-01 | Warnings | M003 |
| Maximum Strength Betadine Clear | BENZALKONIUM CL AND PRAMOXINE HCL | Atlantis Consumer Healthcare, Inc. | 31b94a76-1536-47c0-ab03-e487c2625c58 | 2026-08-31 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a28101f-ea8e-6071-e063-6294a90aad91 | 2026-08-31 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a3e62ce-52dc-121b-e063-6294a90a898f | 2026-08-31 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a49db18-c270-6f46-e063-6294a90afb5d | 2026-08-31 | 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 |