FDA.reportPublic FDA data

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 table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020365Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8793e3be-7409-4f71-9397-abbeacd27cf8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85754-000-02Guardelle52 mL in 1 BOTTLE, PUMPAEROSOL, FOAM521
85754-000-07Guardelle207 mL in 1 BOTTLE, PUMPAEROSOL, FOAM2071
85754-000-18Guardelle500 mL in 1 BOTTLE, PUMPAEROSOL, FOAM5001

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.

Matched openFDA labels page 17 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Assorted Hand Sanitizer AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.53de29d2-ebf1-7193-e063-6294a90ab3832026-06-09WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Pistachio CremeALCOHOLShenzhen Lantern Scicence Co.,Ltd.53de8eef-b344-3e25-e063-6394a90a01d82026-06-09WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitize Caramel LatteALCOHOLShenzhen Lantern Scicence Co.,Ltd.53df1a36-9b0a-4696-e063-6394a90a91a42026-06-09WarningsExact identifier
application number: M003
MISTIFY COTTON CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006e7bf-96f6-1faa-e063-6394a90ab5a32026-06-08WarningsExact identifier
application number: M003
Povidone-IodinePOVIDONE-IODINEH E B4a7a627c-505d-992b-e063-6394a90a54ca2026-06-04Warnings, Adverse reactionsExact identifier
application number: M003
GNP Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLAmerisource Bergen03247512-7a31-4fb4-b7e0-efc337cab6932026-06-04WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINEAmerisource Bergenf69a5cec-04f2-4028-94c6-1f129d2de5a92026-06-04WarningsExact identifier
application number: M003
GNP Isopropyl Rubbing Alcohol 70 PercentISOPROPYL ALCOHOLAmerisource Bergen0ffd9643-3bc2-4b04-92c5-80fe5e429a252026-06-04WarningsExact identifier
application number: M003
PESI VANILLA HYDRATIING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53325d04-26db-fc62-e063-6394a90a322a2026-06-01WarningsExact identifier
application number: M003
KOOL AID PPINK LEMONADE HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53342b67-8742-1387-e063-6394a90acc742026-06-01WarningsExact identifier
application number: M003
ICEE CHERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53352f95-6477-25e3-e063-6394a90a9e022026-06-01WarningsExact identifier
application number: M003
JOLLY RANCHER BLUE RASPBERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53357f28-a843-ec12-e063-6294a90a16fc2026-06-01WarningsExact identifier
application number: M003
SOURPATCHKIDS STRAWBERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53358c4e-3021-1e85-e063-6294a90a07382026-06-01WarningsExact identifier
application number: M003
GUSHERS TROPICAL HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53359191-0451-a1a0-e063-6394a90a81a12026-06-01WarningsExact identifier
application number: M003
MOUNTAIN DEW HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53359746-6033-c3d2-e063-6394a90a677c2026-06-01WarningsExact identifier
application number: M003
FLUFFY STUFF COTTON CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5335d246-5c4c-6773-e063-6294a90a8ffa2026-06-01WarningsExact identifier
application number: M003
DUBBLE BUBBLE ORIGINAL FLAVOR BUBBLE GUM HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5335d97d-3d8e-fc86-e063-6394a90abaad2026-06-01WarningsExact identifier
application number: M003
MISTIFY PUMPKIN HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e262fe-9a91-59c2-e063-6394a90ac32a2026-06-01WarningsExact identifier
application number: M003
MISTIFY CINNAMON HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e23fce-8560-087e-e063-6294a90a73bb2026-06-01WarningsExact identifier
application number: M003
MISTIFY SMORES HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e2c4c4-0cdb-2d24-e063-6294a90a082f2026-06-01WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN8793e3be-7409-4f71-9397-abbeacd27cf81
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD8793e3be-7409-4f71-9397-abbeacd27cf81
1020365benzalkonium chloride 0.13 % Topical FoamSY8793e3be-7409-4f71-9397-abbeacd27cf81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85754-000-028575400000252 mL in 1 BOTTLE, PUMP (85754-000-02) 52 ml2025-10-16NoNoCurrent
85754-000-0785754000007207 mL in 1 BOTTLE, PUMP (85754-000-07) 207 ml2025-10-16NoNoCurrent
85754-000-1885754000018500 mL in 1 BOTTLE, PUMP (85754-000-18) 500 ml2025-10-16NoNoCurrent