FDA.reportPublic FDA data

NasalGuard Antiseptic Topical Cool Menthol

Product NDC
81907-101
Requested package NDC
81907-101-01
11-digit product format
819070101
Labeler code
81907
Product ID
81907-101_5a71fe2f-cad5-bdc5-e063-6294a90aefcb
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
GEL
Route
TOPICAL
Labeler
TRUTEK CORP.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-24
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/1000mg
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage81907-10181907-101-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
NasalGuard Antiseptic Topical Cool Menthol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/1000mg

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
1098199Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9fd3ef8-78ff-6c9f-e053-2a95a90a21a8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81907-101-01NasalGuard Antiseptic Topical Cool Menthol1 in 1 BOXGEL19
81907-101-03NasalGuard Antiseptic Topical Cool Menthol3000 mg in 1 TUBEGEL30009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81907-101NASALGUARD ANTISEPTIC TOPICAL COOL MENTHOL (BENZALKONIUM CHLORIDE) GEL [TRUTEK CORP.]8Current NDC, Legacy NDC, 2 package rows20250117_e9fd3ef8-78ff-6c9f-e053-2a95a90a21a8.zip

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 79 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Germ Attack 70% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375d44e-5af6-8c7f-e063-6394a90abb4b2025-04-25WarningsExact identifier
application number: M003
Germ Attack 91% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375e0d7-07fa-6489-e063-6294a90a91ec2025-04-25WarningsExact identifier
application number: M003
Clear DefenseHAND SANITIZING WIPESMelaleuca, Inc.30dec472-8112-37d6-e063-6294a90a1f252025-04-24WarningsExact identifier
application number: M003
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.3347184c-ae72-bec2-e063-6294a90a2d052025-04-23WarningsExact identifier
application number: M003
Dukal Sterile Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC00b2c444-8601-4d8f-b6bb-91b864fd90412025-04-23WarningsExact identifier
application number: M003
PREVENT HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCee2c3dd2-a82f-4bbf-a288-f0365b9893db2025-04-23WarningsExact identifier
application number: M003
SANIFOAM HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCe1cfa8ff-92e0-4931-98c9-287c8dcd5a992025-04-23WarningsExact identifier
application number: M003
ANTIBACTERIAL WASH FOAM ITEM 1081CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC18720bd0-6ea8-2d1b-e063-6394a90abe2d2025-04-23WarningsExact identifier
application number: M003
E-2 HAND ITEM 1095CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC18728ebb-c416-5efe-e063-6294a90abd912025-04-23WarningsExact identifier
application number: M003
PEARL ANTIMICROBIAL HAND ITEM 1027AB-01CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871b1db-f881-e7fd-e063-6294a90ada982025-04-23WarningsExact identifier
application number: M003
SOFT TOUCH PLUS ANTIBACTERIAL HAND ITEM 1039CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1870b08e-e5c3-7888-e063-6394a90a1c822025-04-23WarningsExact identifier
application number: M003
SUPER SUDS ANTIBACTERIAL HAND ITEM 1063CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871e729-6b76-084e-e063-6394a90a795d2025-04-23WarningsExact identifier
application number: M003
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEEDLIDOCAINE, MENTHOLCompass Health Brands Corp.2c38a4be-fcbe-9d1d-e063-6294a90a93732025-04-22WarningsExact identifier
application number: M003
Sierra Soft Antibacterial WashCHLOROXYLENOLCWGC LA Inc.49034ae5-be47-4472-a4e5-b5bf633355ed2025-04-21WarningsExact identifier
application number: M003
AplicareHYDROGEN PEROXIDEAplicare Products LLC0b3e5df6-03c8-3880-e063-6394a90a1cdc2025-04-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDETotal Resources Internationalb971cc41-fe23-4be3-9564-e46d55df1d682025-04-18WarningsExact identifier
application number: M003
Sierra Soft Alcohol Hand SanitizerETHYL ALCOHOLCWGC LA Inc.012463da-94cf-4975-9fa2-6c323855bf572025-04-17WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp323c61fd-adee-393c-e063-6394a90a5eb32025-04-15WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp324b140d-9d43-1c2f-e063-6294a90ae3032025-04-15WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTARGET Corporation126ec829-c54c-4927-bbd5-a8156d2f6eea2025-04-14WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098199benzalkonium chloride 0.13 % Topical GelPSNe9fd3ef8-78ff-6c9f-e053-2a95a90a21a89
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCDe9fd3ef8-78ff-6c9f-e053-2a95a90a21a89
1098199benzalkonium chloride 0.13 % Topical GelSYe9fd3ef8-78ff-6c9f-e053-2a95a90a21a89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81907-101-01819070101011 TUBE in 1 BOX (81907-101-01) / 3000 mg in 1 TUBE (81907-101-03) 1 tube2024-02-01NoNoCurrent