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 114 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.5854f241-6cfc-4e5a-ba72-92dd0703f7282023-10-13WarningsExact identifier
application number: M003
DawnMist Alcohol Hand SanitizerALCOHOLDukal LLCa2df96a9-8514-6839-e053-2a95a90a94172023-10-13WarningsExact identifier
application number: M003
DUKAL STING RELIEF PADBENZOCAINEDukal LLC67c1ddc7-8fde-4431-84cb-f757682d5f3e2023-10-13WarningsExact identifier
application number: M003
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDEAcme United Corporation07245b54-b193-178e-e063-6394a90a25812023-10-09WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLRejoice International Corp.06dc1730-216a-8b4d-e063-6294a90a41842023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dcf8dc-0831-475e-e063-6394a90a9fef2023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dd2427-097c-b0fa-e063-6294a90a4f822023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLRejoice International Corp.06da0cc1-95f2-4f88-e063-6394a90a25ea2023-10-03WarningsExact identifier
application number: M003
First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite AidISOPROPYL ALCOHOLRite Aid Corporationaa0df5fe-62d1-407d-b8f9-a7fd9473d5692023-10-02WarningsExact identifier
application number: M003
Foaming Instant Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.5c1f69b7-c8d8-477c-b614-47a3287b0e4c2023-06-05WarningsExact identifier
application number: M003
Bactine Max DryLIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation466404cd-c46a-4944-b1ac-3b3b17f436a12022-12-27WarningsExact identifier
application number: M003
Povidone-Iodine PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
application number: M003
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
application number: M003
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
application number: M003
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
application number: M003
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact 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