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 32 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES5a503d8d-7899-4b1e-be6f-8e2a759af2652024-12-04WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESCVS Pharmacy, Inc.6dffc3f5-bae0-c436-e053-2991aa0a0f8b2024-12-02WarningsExact identifier
application number: M007
Pure and GentleMINERAL OILMedline Industries, LP96d4cad5-0602-4c31-94ed-3117b4fd4a942024-11-26WarningsExact identifier
application number: M007
Pure and Gentle LaxativeSODIUM PHOSPHATEMedline Industries, LPe3165538-75dd-4f0f-adc8-d4075de10f1e2024-11-26WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50 MGDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.af7533e6-8b06-48a4-940e-7ecb57b24b592024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a923e5ca-86fd-4bf9-9931-180ddfdeae662024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.7cf1df18-d658-4bff-8a62-365fc56569422024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mgDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.c5bdfbfc-d24a-4088-9b60-ecea8120ff432024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.85c64624-428d-46fa-8071-f42b8feec0492024-11-21WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd33251cb7-b7b1-4f6c-9e10-4fa64cbf03a02024-11-21WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
application number: M007
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
application number: M007
ReliefSODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATELeosons Overseas Corp5b301d5b-1e2c-47ed-a05f-d6be0fdfc9402024-11-19WarningsExact identifier
application number: M007
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
application number: M007
Milk of Magnesia ConcentrateMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2a99a1a8-a830-429f-9cfd-3f29c3d3547c2024-11-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions122486e9-74dd-4181-97d1-0b07688280f42024-11-06WarningsExact identifier
application number: M007
Stratuscare Adult GlycerinGLYCERINStratus Pharmaceuticals3e1935da-5c1f-4942-98dd-320fade823212024-11-04WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.fdf3c8e1-d554-4cdb-e053-6394a90a542e2024-11-01WarningsExact 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