FDA.reportPublic FDA data

Northside Hospital Amenity Kit--GI Dept

Product NDC
59448-201
11-digit product format
594480201
Labeler code
59448
Product ID
59448-201_66ebc39b-2b05-49fa-938c-8f3e25e8ebbc
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
KIT
Labeler
ASP Global, LLc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-18
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
Northside Hospital Amenity Kit--GI Dept
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
c284eba4-0b92-4981-b3f8-d8d99b58bdfdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-001-02Northside Hospital Amenity Kit--GI Dept53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL8
59448-201-00Northside Hospital Amenity Kit--GI Dept1 in 1 BAGKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-201NORTHSIDE HOSPITAL AMENITY KIT--GI DEPT (ALCOHOL) KIT [ASP GLOBAL, LLC]8Current NDC, Legacy NDC, 2 package rows20240112_c284eba4-0b92-4981-b3f8-d8d99b58bdfd.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 115 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 GelPSNc284eba4-0b92-4981-b3f8-d8d99b58bdfd8
581660ethanol 0.62 ML/ML Topical GelSCDc284eba4-0b92-4981-b3f8-d8d99b58bdfd8
581660ethanol 62 % Topical GelSYc284eba4-0b92-4981-b3f8-d8d99b58bdfd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-001-025944800010253 mL in 1 BOTTLE, PLASTIC53 mlHistorical
59448-201-00594480201001 KIT in 1 BAG (59448-201-00) * 53 mL in 1 BOTTLE, PLASTIC (59448-001-02) * 4.25 g in 1 TUBE1 kit2016-01-180000-00-00NoNoCurrent