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 1 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
application number: M003
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
application number: M003
Henry Schein Povidone-Iodine Prep PadPOVIDONE-IODINEHenry Schein, Inc.313416b8-60b2-4a77-9b56-5c507aae90722026-09-08WarningsExact identifier
application number: M003
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
application number: M003
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
application number: M003
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
application number: M003
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
application number: M003
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
application number: M003
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
application number: M003
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
application number: M003
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
application number: M003
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
application number: M003
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
application number: M003
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
application number: M003
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
application number: M003
Members MarkISOPROPYL ALCOHOLSams West Incc251ac50-f74f-4a48-e053-2a95a90aac0d2026-09-04WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart, Inc.2f1342ef-1843-40a6-e063-6294a90a577f2026-09-04WarningsExact identifier
application number: M003
Curad Alcohol Prep Pads MediumISOPROPYL ALCOHOLMedline Industries, LP1ce3872e-2307-4a38-bd7d-7eb2b226cf3c2026-09-04WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLSuperValu, Inc.5e6e6d6f-4472-40f1-b0a9-96cee7ef075b2026-09-04WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLFoodhold U.S.A. LLCa94c023c-5313-4940-90a7-b3061a8b90e12026-09-04WarningsExact 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