FDA.reportPublic FDA data

Wellstar Amenity

Product NDC
59448-800
11-digit product format
594480800
Labeler code
59448
Product ID
59448-800_961c53ef-0590-4aa8-8cef-667615bd0c4b
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride and SODIUM MONOFLUOROPHOSPHATE
Dosage form
KIT
Labeler
ASP Global, LLc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-01
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
Wellstar Amenity
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ced9dd96-7922-43d7-906f-32afaad733ecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-008-01Wellstar Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL4
59448-800-00Wellstar Amenity20 in 1 BOXKIT204
59448-800-00Wellstar Amenity1 in 1 BAGKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-800WELLSTAR AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ) KIT [ASP GLOBAL, LLC]4Current NDC, Legacy NDC, 3 package rows20241222_ced9dd96-7922-43d7-906f-32afaad733ec.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 93 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5ee961-1d64-0d9d-e053-2a95a90a60102024-12-18WarningsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLSZY Holdings, LLC dba EverReady First Aid1e39b0f4-66d1-47ac-aed6-d6ac019888ce2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5eb0df-cd2d-691c-e053-2995a90a25112024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLFirst Aid Research Corp.7d1c0382-31b3-48d0-a514-c5cc45a2299e2024-12-18WarningsExact identifier
application number: M003
First Aid Only First Aid-BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEAcme United Corporationf31a44ff-e4ac-de1e-e053-2a95a90ab0362024-12-18WarningsExact identifier
application number: M003
Hand Sanitizer (Lavender Rosemary)HAND SANITIZER SPRAYTubby Todd2992a52a-21a9-18be-e063-6294a90a834d2024-12-18WarningsExact identifier
application number: M003
CVS Decolorized IodineALCOHOLCVS Pharmacyd9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd2024-12-18WarningsExact identifier
application number: M003
De La Cruz Decolorized IodineETHYL ALCOHOLDLC Laboratories, Inc.5d8f6aaa-0b87-1166-e053-2991aa0a297f2024-12-18WarningsExact identifier
application number: M003
Humco Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.1e078022-f32c-48bd-8add-f83aebcc58122024-12-18WarningsExact identifier
application number: M003
Univ of Vermont Medical Center AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7841cfa9-e94e-4c3d-b5fb-6769240178452024-12-17WarningsExact identifier
application number: M003
Northside Hospital Mothers VaginalALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7f1a85fd-086b-4fc7-abac-863dd3ea505a2024-12-17WarningsExact identifier
application number: M003
Mary Kay Satin Hands Shea Hand SanitizerALCOHOLMary Kay Inc.b6c2b979-2940-1569-e053-2995a90a532c2024-12-17WarningsExact identifier
application number: M003
Foster and Thrive Decolorized IodineALCOHOL LIQUIDStrategic Sourcing Services, LLC2981529a-2bd0-3e9e-e063-6294a90a72362024-12-17WarningsExact identifier
application number: M003
Foster and Thrive 2% Mild Iodine TinctureIODINE AND SODIUM IODIDE AND ALCOHOL LIQUIDStrategic Sourcing Services, LLC2981cb97-17de-ebda-e063-6394a90ad2812024-12-17WarningsExact identifier
application number: M003
Northside Hospital H.E.A.R.T. Strings ToteALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLcf8369a27-1995-4fdd-a282-35c344c11d832024-12-17WarningsExact identifier
application number: M003
Northside Hospital Amenity KitALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLc877ce875-c5b0-4d9b-8f00-682914e3bc0e2024-12-17WarningsExact identifier
application number: M003
Wellstar AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcced9dd96-7922-43d7-906f-32afaad733ec2024-12-17WarningsExact identifier
application number: M003
ndc (product): 59448-800
Northside Hospital C-Section MothersALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc9df6d0e9-631c-4619-9d96-d2c5a32a590e2024-12-17WarningsExact identifier
application number: M003
Memorial Sloan Kettering Cancer Center Amenity KitSODIUM MONOFLUOROPHOSPHATEASP Global, LLccab0bef1-f486-4eac-a61b-6030467d86502024-12-17WarningsExact identifier
application number: M003
Sarasota Memorial AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcf5dda019-fcfd-4e99-89cc-e79e76b402e72024-12-17WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.76 % ToothpastePSNced9dd96-7922-43d7-906f-32afaad733ec4
581660ethanol 0.62 ML/ML Topical GelSCDced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDced9dd96-7922-43d7-906f-32afaad733ec4
581660ethanol 62 % Topical GelSYced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYced9dd96-7922-43d7-906f-32afaad733ec4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-008-015944800080153 mL in 1 BOTTLE, PLASTIC53 mlHistorical
59448-800-005944808000020 BAG in 1 BOX (59448-800-00) / 1 KIT in 1 BAG * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 59 mL in 1 TUBE * 14 g in 1 BOTTLE, WITH APPLICATOR * 59 mL in 1 TUBE * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC (59448-008-01) 20 bag2021-10-010000-00-00NoNoCurrent