FDA.reportPublic FDA data

Purifi Hand Sanitizer

Product NDC
80659-301
11-digit product format
806590301
Labeler code
80659
Product ID
80659-301_103dc041-e75d-b464-e063-6394a90ab4d8
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Purifi LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-10
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Purifi Hand Sanitizer
Listing expiration
2027-12-31

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
1049254Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9267069d-4cf5-4e48-a446-7dbebea16bf5Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
80659-301-012024-01-31Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-022024-01-31Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-032024-01-31Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-042024-01-31Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-052024-01-31Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-012022-01-31Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-022022-01-31Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-032022-01-31Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-042022-01-31Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-052022-01-31Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-012022-01-28Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-022022-01-28Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-032022-01-28Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-042022-01-28Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS
80659-301-052022-01-28Purifi Moisturizing Hand Sanitizer INSTANTLY KILLS 99.99% OF TESTED GERMS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80659-301-01Purifi Hand Sanitizer250 mL in 1 BOTTLE, PLASTICSOLUTION2504
80659-301-02Purifi Hand Sanitizer60 mL in 1 BOTTLE, PLASTICSOLUTION604
80659-301-03Purifi Hand Sanitizer3800 mL in 1 BOTTLE, PLASTICSOLUTION38004
80659-301-04Purifi Hand Sanitizer50 mL in 1 BOTTLE, PLASTICSOLUTION504
80659-301-05Purifi Hand Sanitizer296 mL in 1 BOTTLE, PLASTICSOLUTION2964

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80659-301PURIFI HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [PURIFI LLC]4Current NDC, Legacy NDC, 5 package rows20240201_9267069d-4cf5-4e48-a446-7dbebea16bf5.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 39 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPEPharma Nobis, LLCf0488c86-6c74-3987-e053-2a95a90a31b42023-12-22WarningsExact identifier
application number: M007
Mineral Oil HeavyMINERAL OILPharma Nobis, LLCe42f6c6d-c4de-02c6-e053-2995a90a3ace2023-12-22WarningsExact identifier
application number: M007
Quality Choice Castor OilCASTOR OILChain Drug Market Asociation18d7124f-7745-45b2-adc4-cb1103add5d62023-12-20WarningsExact identifier
application number: M007
Premiere Value Castor OilCASTOR OILChain Drug Consortium5c8c1564-fcff-894b-e053-2991aa0a9c0b2023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRYBionpharma, Inc.f0fa4b72-50a5-5c42-e053-2995a90a159a2023-12-20WarningsExact identifier
application number: M007
Harris Teeter Castor OilCASTOR OILHarris Teeter, LLC5cca6b4b-d88f-1c7d-e053-2991aa0a051f2023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMONBionpharma, Inc.f0f9c36e-c43b-05d2-e053-2995a90a6d652023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPEBionpharma, Inc.f0f9ff19-ae08-0af0-e053-2a95a90ab8422023-12-20WarningsExact identifier
application number: M007
CVS Mineral OilMINERAL OILCVS9d7402e1-524b-1084-e053-2a95a90ae3af2023-12-20WarningsExact identifier
application number: M007
Top Care Castor OilCASTOR OILTOPCO ASSOCIATES LLC8dce1a1f-e765-9c75-e053-2995a90abf9f2023-12-18WarningsExact identifier
application number: M007
Humco Epson SaltMAGNESIUM SULFATEHumco Holding Group, Inc.7a9d1b77-6c39-46f1-86f2-4059dde20f852023-12-15WarningsExact identifier
application number: M007
Humco Mineral Oil HeavyMINERAL OILHumco Holding Group, Inc.9f943fdf-5058-4e18-ba96-6be112bf72ca2023-12-15WarningsExact identifier
application number: M007
Rite Aid Castor OilCASTOR OILRite Aid Corporation.5e0d3664-b01b-ba28-e053-2991aa0a8a4c2023-12-15WarningsExact identifier
application number: M007
GNP Castor OilCASTOR OILAmerisource Bergen5d06bec6-f1e7-4f0c-e053-2991aa0a8ad82023-12-14WarningsExact identifier
application number: M007
SankaijoDOCUSATE SODIUM, SENNOSIDESSato Pharmaceutical Co., Ltd.83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b2023-11-29WarningsExact identifier
application number: M007
SIMPEX Bisacodyl laxativeBISACODYLSimpex Pharma Pvt. Ltd5114ed64-4fec-401b-8a91-8df3e42b10b12023-11-29WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corpb595063a-5fee-18c2-e053-2a95a90a5b992023-11-15WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPublixcbf7dcef-7623-b333-e053-2a95a90a0f1a2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEMeijer, Inc.bb8b51e9-ba4a-270d-e053-2a95a90a318b2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDESTRATEGIC SOURCING SERVICES LLCff0d4b9f-7ce8-dd98-e053-6394a90ab6142023-11-08WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN9267069d-4cf5-4e48-a446-7dbebea16bf54
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD9267069d-4cf5-4e48-a446-7dbebea16bf54
1049254benzalkonium chloride 0.13 % Topical SolutionSY9267069d-4cf5-4e48-a446-7dbebea16bf54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80659-301-0180659030101250 mL in 1 BOTTLE, PLASTIC (80659-301-01) 250 ml2020-12-100000-00-00NoNoCurrent
80659-301-028065903010260 mL in 1 BOTTLE, PLASTIC (80659-301-02) 60 ml2020-12-100000-00-00NoNoCurrent
80659-301-03806590301033800 mL in 1 BOTTLE, PLASTIC (80659-301-03) 3800 ml2020-12-100000-00-00NoNoCurrent
80659-301-048065903010450 mL in 1 BOTTLE, PLASTIC (80659-301-04) 50 ml2020-12-100000-00-00NoNoCurrent
80659-301-0580659030105296 mL in 1 BOTTLE, PLASTIC (80659-301-05) 296 ml2020-12-100000-00-00NoNoCurrent