FDA.reportPublic FDA data

Emory Johns Creek Amenity

Product NDC
59448-700
11-digit product format
594480700
Labeler code
59448
Product ID
59448-700_97b4f6bd-9504-45e3-aa37-b36c0552ed09
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol and Sodium Monofluorophospate
Dosage form
KIT
Labeler
ASP Global
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-27
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
Emory Johns Creek 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
952ccb85-71bb-4d5d-ac9b-62851a39d36dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-004-01Emory Johns Creek Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL4
59448-700-00Emory Johns Creek Amenity1 in 1 BAGKIT14
59448-700-00Emory Johns Creek Amenity30 in 1 BOXKIT304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-700EMORY JOHNS CREEK AMENITY (ALCOHOL AND SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL]4Current NDC, Legacy NDC, 3 package rows20241222_952ccb85-71bb-4d5d-ac9b-62851a39d36d.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 2 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MeijerISOPROPYL ALCOHOLMeijer Distribution Incca008d84-cf51-3703-e053-2a95a90a9bf12026-09-04WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart, Inc.2eff98ba-5736-b07e-e063-6394a90aeea92026-09-04WarningsExact identifier
application number: M003
Walgreen AlcoholISOPROPYL ALCOHOLWalgreens Companydeeae1ea-3d81-4260-95be-c4f328e3fdef2026-09-04WarningsExact identifier
application number: M003
Dollar GeneralISOPROPYL ALCOHOLDollar General Corporation00b2ef34-42d9-523c-e063-6294a90a753d2026-09-03WarningsExact identifier
application number: M003
Signature Select Alcohol Prep PadsISOPROPYL ALCOHOLBetter Living Brands LLC31ce72e3-03a3-1608-e063-6394a90ad8502026-09-03WarningsExact identifier
application number: M003
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEKroger Co.fe604470-917f-4cbd-a1e6-ac1dc7c57ff62026-09-02WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLRite Aid Corporation5104f9ab-0b28-449f-a55a-5438713a24df2026-09-02WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUpLift Brands, LLC5a81b635-d188-0b29-e063-6294a90a1e4b2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDECVS Pharmacy, Inc.7f518646-c8fe-499a-b5e4-8e5a5a90e01d2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLThe Kroger Company6551187f-5cde-4149-931f-b057bd7607502026-09-02WarningsExact identifier
application number: M003
Unscented NasalGuard Antiseptic TopicalBENZALKONIUM CHLORIDETRUTEK CORP.eb036e11-a28c-fdc0-e053-2a95a90a9cdb2026-09-02WarningsExact identifier
application number: M003
Harris TeeterISOPROPYL ALCOHOLHarris Teeter, LLCd2bb20bd-ec83-8d80-e053-2a95a90a2bba2026-09-02WarningsExact identifier
application number: M003
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-09-02WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLTopco Associates2642298f-607e-fdca-e063-6394a90a69d92026-09-02WarningsExact identifier
application number: M003
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
application number: M003
NasalGuard Antiseptic Topical Cool MentholBENZALKONIUM CHLORIDETRUTEK CORP.e9fd3ef8-78ff-6c9f-e053-2a95a90a21a82026-09-01WarningsExact identifier
application number: M003
Maximum Strength Betadine ClearBENZALKONIUM CL AND PRAMOXINE HCLAtlantis Consumer Healthcare, Inc.31b94a76-1536-47c0-ab03-e487c2625c582026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a28101f-ea8e-6071-e063-6294a90aad912026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a3e62ce-52dc-121b-e063-6294a90a898f2026-08-31WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN952ccb85-71bb-4d5d-ac9b-62851a39d36d4
545626sodium monofluorophosphate 0.76 % ToothpastePSN952ccb85-71bb-4d5d-ac9b-62851a39d36d4
581660ethanol 0.62 ML/ML Topical GelSCD952ccb85-71bb-4d5d-ac9b-62851a39d36d4
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD952ccb85-71bb-4d5d-ac9b-62851a39d36d4
581660ethanol 62 % Topical GelSY952ccb85-71bb-4d5d-ac9b-62851a39d36d4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY952ccb85-71bb-4d5d-ac9b-62851a39d36d4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY952ccb85-71bb-4d5d-ac9b-62851a39d36d4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY952ccb85-71bb-4d5d-ac9b-62851a39d36d4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY952ccb85-71bb-4d5d-ac9b-62851a39d36d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-004-015944800040153 mL in 1 BOTTLE, PLASTIC53 mlHistorical
59448-700-005944807000030 BAG in 1 BOX (59448-700-00) / 1 KIT in 1 BAG * 10 g in 1 TUBE (42555-060-45) * 4.25 g in 1 TUBE * 14 g in 1 BOTTLE, WITH APPLICATOR * 53 mL in 1 BOTTLE, PLASTIC (59448-004-01) 30 bag2020-07-270000-00-00NoNoCurrent