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 91 percent | ISOPROPYL ALCOHOL | P & L Development, LLC | fcda76cb-63c4-4e81-9e0a-13be506a8150 | 2026-06-17 | Warnings | M003 |
| Novo Wipe | NOVO WIPE | SHENZHEN BENLIJU BIO-TECH CO.,LTD | 545c6386-139e-cb9b-e063-6394a90a0456 | 2026-06-16 | Warnings | M003 |
| 70% | ISOPROPYL ALCOHOL | Meijer, Inc. | 7b1f93ff-5eeb-4da1-8f02-7c47d713689a | 2026-06-15 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Meijer, Inc. | 531cea18-9609-4d78-876d-3ba5d2d1e16f | 2026-06-15 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Meijer, Inc. | b0d302c2-58a0-4c3e-9c4a-fd34de40c034 | 2026-06-15 | Warnings, Adverse reactions | M003 |
| Antiseptic | BENZALKONIUM CHLORIDE, BENZOCAINE | Wildman Business Group | 1fd15b91-6b81-d0bd-e063-6294a90a4d27 | 2026-06-15 | Warnings | M003 |
| GLOBAL CARE GOLD ANTIBACTERIAL HAND | BENZALKONIUM CHLORIDE | NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. | 540bde3c-5af2-456a-e063-6294a90aa774 | 2026-06-12 | Warnings | M003 |
| Smart Care Hand Sanitizer Fall Scents-Apple | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 541a09b6-2928-9fbf-e063-6394a90a3c4d | 2026-06-12 | Warnings | M003 |
| Smart Care Hand Sanitizer Holiday-Spiced Cranberry | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 541a41cf-5c63-c6fc-e063-6294a90abfcc | 2026-06-12 | Warnings | M003 |
| Smart Care Hand Sanitizer Holiday-Mistletoe | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 541a8aa9-1d4b-28ec-e063-6294a90aa34e | 2026-06-12 | Warnings | M003 |
| Hand Sanitizer | ALCOHOL | Guangdong Yanze Biotechnology Co., Ltd. | 5211ec31-90bc-e0fc-e063-6294a90a76ed | 2026-06-11 | Warnings | M003 |
| Smart Care Squishmallows Hand Sanitizer | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 53f5d658-dd1a-bb8e-e063-6294a90adbb1 | 2026-06-11 | Warnings | M003 |
| Smart Care Hand Sanitizer Fall Scents-Pumpkin Spice | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 53f6c000-849b-0045-e063-6294a90aa2f1 | 2026-06-11 | Warnings | M003 |
| EVR Alcohol Prep Pads | LSOPROPYL ALCOHOL | JINHUA JINGDI MEDICAL SUPPLIES CO.,LTD | 5406ba2f-6729-b9e7-e063-6394a90ac553 | 2026-06-11 | Warnings | M003 |
| MISTIFY FROSTY CANDY HAND SANITIZER | ALCOHOL ANTISEPTIC | Kingkey MBC Life Technology Group Co.,Ltd | 53e4f854-750b-7322-e063-6294a90a1110 | 2026-06-10 | Warnings | M003 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 53ea8cec-bf36-4eec-e063-6394a90a559c | 2026-06-10 | Warnings | M003 |
| Isopropyl alcohol | ISOPROPYL ALCOHOL | CVS PHARMACY, INC | b30468f6-7a1b-4165-916f-36df21eb10e5 | 2026-06-09 | Warnings | M003 |
| Benzethonium chloride and Dyclonine hydrochloride | LIQUID BANDAGE | Chain Drug Marketing Association | 34062b23-52aa-99ae-e063-6294a90ae73f | 2026-06-09 | Warnings | M003 |
| Benzethonium chloride Plus Dyclonine hydrochloride | LIQUID BANDAGE | Chain Drug Marketing Association | 2419c9f9-3e15-4d0e-b422-a6110281fd1d | 2026-06-09 | Warnings | M003 |
| Smart Care Assorted Hand Sanitizer Pumpkin Spice | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 53dd3d76-81c9-ed6b-e063-6394a90aaea3 | 2026-06-09 | 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 |