FDA.reportPublic FDA data

Sarasota Memorial Amenity

Product NDC
59448-600
11-digit product format
594480600
Labeler code
59448
Product ID
59448-600_db5d3143-b67b-4dd3-b751-012f3ba86db9
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol and Sodium Monofluorophosphate
Dosage form
KIT
Labeler
ASP Global, LLc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-08
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
Sarasota Memorial 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
f5dda019-fcfd-4e99-89cc-e79e76b402e7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-004-01Sarasota Memorial Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL4
59448-600-00Sarasota Memorial Amenity30 in 1 BOXKIT304
59448-600-00Sarasota Memorial Amenity1 in 1 BAGKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-600SARASOTA MEMORIAL AMENITY (ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]4Current NDC, Legacy NDC, 3 package rows20241222_f5dda019-fcfd-4e99-89cc-e79e76b402e7.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 88 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer Pink SugarALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e5a64-dda1-c24e-e063-6394a90a82982025-02-01WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEJianerkang Medical Co., Ltd3fce67c9-14e9-4e26-bb7f-9375a7f84a8a2025-01-31WarningsExact identifier
application number: M003
AntisepticALCOHOLWelly Health PCB85ce2c23-25d8-4b35-95ff-99f098d92bc92025-01-29WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e13511b-fbb3-2523-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Strawberry ScentedETHYL ALCOHOLNingbo Rejoice Internationala267a7a2-79b9-1da3-e053-2995a90a3a112025-01-28WarningsExact identifier
application number: M003
On Guard Sanitizing GelALCOHOLdoTERRA International, LLCe4b8b4bb-1d47-6826-e053-2a95a90ab1682025-01-28WarningsExact identifier
application number: M003
germstarLuxeETHYL ALCOHOLSoaptronic, LLC471b466f-e3e5-3601-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.51348666-53e3-4cc7-99ba-cf3f23ddbcf62025-01-27WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa2025-01-27WarningsExact identifier
application number: M003
Easy Care Hand SanitizerALCOHOLGFA Production (Xiamen) Co., Ltd.c7058806-ad4e-6d5f-e053-2a95a90a35e82025-01-27WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk with aloe veraETHYL ALCOHOL 70%Rejoice International Corp.04fd3bbe-1729-a748-e063-6394a90a96552025-01-27WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lemonETHYL ALCOHOL 70%Rejoice International Corp.04fd9665-a6b3-678a-e063-6294a90a60a52025-01-27WarningsExact identifier
application number: M003
GERMSTARORIGINALISOPROPYL ALCOHOLSoaptronic, LLCda3ac935-7dc7-4100-a702-959eb84077b22025-01-24WarningsExact identifier
application number: M003
Germstar Premium Hand SanitizerETHYL ALCOHOLSoaptronic LLC489652af-7333-628a-e054-00144ff8d46c2025-01-24WarningsExact identifier
application number: M003
Little Buddy in a Little TubbyHAND SANITIZING TOWELETTESContinental Research Corpf4fac964-4a27-335d-e053-2a95a90ac4eb2025-01-23WarningsExact identifier
application number: M003
PHARMACYS PRESCRIPTION 8OZ HAND SANITIZERALCOHOLAmerican Consumer Products Corp7a048607-f4c3-6724-e053-2a91aa0ab6f22025-01-23WarningsExact identifier
application number: M003
SANITAXE 27 OZ INSTANT HAND SANITIZER WITH ALOE VERAALCOHOLAmerican Consumer Products Corpa8f00148-b8fa-6c4f-e053-2995a90ac5e22025-01-23WarningsExact identifier
application number: M003
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa9ca8aaa-ea76-7eb5-e053-2995a90adef92025-01-23WarningsExact identifier
application number: M003
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa8c6ef84-b072-72ee-e053-2995a90aa1112025-01-23WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lavenderETHYL ALCOHOL 70%Rejoice International Corp.052031f9-5206-c1bc-e063-6394a90ab0f22025-01-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.76 % ToothpastePSNf5dda019-fcfd-4e99-89cc-e79e76b402e74
581660ethanol 0.62 ML/ML Topical GelSCDf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDf5dda019-fcfd-4e99-89cc-e79e76b402e74
581660ethanol 62 % Topical GelSYf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYf5dda019-fcfd-4e99-89cc-e79e76b402e74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-004-015944800040153 mL in 1 BOTTLE, PLASTIC53 mlHistorical
59448-600-005944806000030 BAG in 1 BOX (59448-600-00) / 1 KIT in 1 BAG * 53 mL in 1 BOTTLE, PLASTIC (59448-004-01) * 10 g in 1 TUBE (42555-060-45) 30 bag2019-10-080000-00-00NoNoCurrent