FDA.reportPublic FDA data

Englewood Amenity

Product NDC
59448-400
11-digit product format
594480400
Labeler code
59448
Product ID
59448-400_e82aa749-3427-4411-95f4-75d74665a58d
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
2018-06-13
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
Englewood 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
2048259Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c9ce1bf-6aa2-4073-ad09-2ddf845102a2Available 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
59448-002-01Englewood Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL0.095 mg in 100mL8
59448-400-00Englewood Amenity20 in 1 BOXKIT208
59448-400-00Englewood Amenity1 in 1 BAGKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-400ENGLEWOOD AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]8Current NDC, Legacy NDC, 3 package rows20241222_7c9ce1bf-6aa2-4073-ad09-2ddf845102a2.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 87 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Assorted Licensed Sanitizer Hot Wheels 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfdd225-24f4-6d57-e063-6394a90a8a242025-02-12WarningsExact identifier
application number: M003
Smart Care Cucumber Melon Hand Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfe0ac7-99d5-aac3-e063-6294a90a31b32025-02-12WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLGood Sense (Geiss, Destin & Dunn, Inc.)ac66be77-d358-44ea-8904-88186a7c2bbb2025-02-07WarningsExact identifier
application number: M003
Rubbing Alcohol 70 Percent IsopropylISOPROPYL ALCOHOLHarris Teeter, LLC4196dd97-9041-4712-8196-02237a3b0cb22025-02-07WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLHarris Teeter, LLC1b044f47-45e1-40a3-81b0-2717ed425f162025-02-07WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e042f5b-3f0c-1830-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e04fa70-c25d-4499-e054-00144ff8d46c2025-02-06WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e05cceb-b8f3-48f7-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz AntisepticETHYL ALCOHOLREJOICE INTERNATIONAL CORP.a0313f20-11dc-6c7d-e053-2a95a90a60f12025-02-06WarningsExact identifier
application number: M003
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f869b3-3004-8b25-e063-6294a90a176e2025-02-06WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)444cd7f4-cf61-49b6-a93e-915d250838da2025-02-06WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON VANILLIAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d613ab9-c87b-1f3c-e063-6394a90a31202025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COCONUTALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6148e2-d959-6150-e063-6294a90acba52025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER WATERMELONALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6175c9-abe5-4c68-e063-6394a90afc362025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.eb5d6739-ee36-cd74-e053-2a95a90ab6592025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.037b4acb-49ca-bc0a-e063-6394a90a1fcc2025-02-05WarningsExact identifier
application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ecef31dc-2f36-b578-e053-2995a90a3acd2025-02-05WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)444883fc-7ae4-4dd3-bd2b-f94c3265c1702025-02-05WarningsExact identifier
application number: M003
PHARMACIST CHOICE ALCOHOL STERILE PREP PADISOPROPYL ALCOHOLSimple Diagnostics0fc4a4b2-342b-5948-e054-00144ff88e882025-02-04WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd32055326-c229-5f10-e063-6394a90ab62c2025-02-01WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048259benzalkonium chloride 0.095 % Topical GelPSN7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.76 % ToothpastePSN7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
2048259benzalkonium chloride 0.00095 MG/MG Topical GelSCD7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
2048259benzalkonium chloride 0.095 % Topical GelSY7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY7c9ce1bf-6aa2-4073-ad09-2ddf845102a28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-002-015944800020153 mL in 1 BOTTLE, PLASTIC53 mlHistorical
59448-400-005944804000020 BAG in 1 BOX (59448-400-00) / 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 (59448-002-01) 20 bag2018-06-130000-00-00NoNoCurrent