FDA.reportPublic FDA data

Instant Hand Antiseptic

Product NDC
59448-001
11-digit product format
594480001
Labeler code
59448
Product ID
59448-001_fb47d785-d6d1-4f51-a34c-8b171ff287a3
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
ASP Global
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-18
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct59448-001IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59448-00159448-001-01IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
Instant Hand Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

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
291eaa18-81f8-6907-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59448-001-012020-01-31C16284748780-19d75b9cf-cfb0-f424-e053-dadaa90a57ce271503b4-2891-0777-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-001-02Northside Hospital Amenity Kit53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL9
59448-001-02Northside Hospital Amenity Kit--GI Dept53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL8
59448-001-02Instant Hand Antiseptic53 mL in 1 BOTTLE, PLASTICGEL537
59448-001-02Northside Hospital C-Section Mothers53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL2
59448-001-02Northside Hospital Mothers Vaginal53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL2
59448-001-02Northside Hospital H.E.A.R.T. Strings Tote53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL2
59448-001-02Northside Hospital Bereavement53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-001NORTHSIDE HOSPITAL AMENITY KIT (ALCOHOL AND SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL, LLC]9Current NDC, Legacy NDC20250101_877ce875-c5b0-4d9b-8f00-682914e3bc0e.zip
59448-001NORTHSIDE HOSPITAL AMENITY KIT--GI DEPT (ALCOHOL) KIT [ASP GLOBAL, LLC]8Current NDC, Legacy NDC20240112_c284eba4-0b92-4981-b3f8-d8d99b58bdfd.zip
59448-001INSTANT HAND ANTISEPTIC (ALCOHOL) GEL [ASP GLOBAL]7Current NDC, Legacy NDC, 1 package rows20241208_291eaa18-81f8-6907-e054-00144ff88e88.zip
59448-001NORTHSIDE HOSPITAL C-SECTION MOTHERS (ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]2Current NDC, Legacy NDC20250101_9df6d0e9-631c-4619-9d96-d2c5a32a590e.zip
59448-001NORTHSIDE HOSPITAL H.E.A.R.T. STRINGS TOTE (ALCOHOL AND SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL, LLC]2Current NDC, Legacy NDC20250101_f8369a27-1995-4fdd-a282-35c344c11d83.zip
59448-001NORTHSIDE HOSPITAL MOTHERS VAGINAL (ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]2Current NDC, Legacy NDC20250101_7f1a85fd-086b-4fc7-abac-863dd3ea505a.zip
59448-001NORTHSIDE HOSPITAL BEREAVEMENT (ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]1Current NDC, Legacy NDC20171027_0143ea6d-8dde-4b6d-9b08-eaa27bbc270a.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 104 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safly BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.5cd9043e-daf2-43eb-9568-54775fc4f84a2024-05-15WarningsExact identifier
application number: M003
Noshinku Bergamot Hand SanitizerALCOHOLNoshinku53fea81e-4482-6fae-e054-00144ff8d46c2024-05-14WarningsExact identifier
application number: M003
Noshinku Eucalyptus Hand SanitizerALCOHOLNoshinku9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c02024-05-14WarningsExact identifier
application number: M003
Noshinku Lavender Hand SanitizerALCOHOLNoshinkua57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf2024-05-14WarningsExact identifier
application number: M003
LEADER 2% Mild Iodine TinctureIODINE AND SODIUM IODIDE AND ALCOHOL LIQUIDCardinal Health, 110 dba Leader7f810b92-60f6-2f72-e053-2991aa0ab9732024-05-13WarningsExact identifier
application number: M003
Leader Decolorized IodineALCOHOL LIQUIDCardinal Health, 110 dba Leader822f6f28-956f-dd82-e053-2991aa0ae7522024-05-13WarningsExact identifier
application number: M003
Inverness Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a2995-334c-2e93-e063-6294a90aecf72024-05-09WarningsExact identifier
application number: M003
Helzberg Diamonds Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a3776-0edd-26f3-e063-6294a90a740d2024-05-09WarningsExact identifier
application number: M003
Ulta Beauty Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a37f4-8718-3e40-e063-6294a90acaad2024-05-09WarningsExact identifier
application number: M003
Guardian VaginalBENZALKONIUM CHLORIDEEastern Century Pharmaceuticals1605ba44-02b7-4c72-9fec-89a5aa962b442024-04-24WarningsExact identifier
application number: M003
Inverness Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.0ccd72e7-16a2-47c7-9ce6-dffb63a0344b2024-04-18WarningsExact identifier
application number: M003
Lovisa Piercing Care SolutionBENZALKONIUM CHLORIDEThe Richline Group, Inc.74f46b81-cc5b-4e3f-a36e-0bd86d370c222024-04-18WarningsExact identifier
application number: M003
CliniClean BZK Cleansing Contains Benzalkonium ChlorideBENZALKONIUM CHLORIDEHR HealthCareb6916466-0931-408f-a430-0797a449c32e2024-04-18WarningsExact identifier
application number: M003
Handy Solutions First Aid KitBENZALKONIUM CHLORIDENavajo Manufacturing Company Inc.130237ff-3db4-1288-e063-6394a90ab1af2024-04-16WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEHenry Schein Inc.ff877b63-fa58-4770-a882-694eda33203b2024-04-02WarningsExact identifier
application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine HydrochlorideBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.8e1f35ff-d4e6-4940-ad8f-dce2b73e595d2024-04-01WarningsExact identifier
application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICASBENZALKONIUM CHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.b267e186-cf7a-458f-9c28-a48a8554af402024-04-01WarningsExact identifier
application number: M003
Antiseptic Povidone Iodine Prep PadPOVIDONE-IODINEM-star (Hubei) Health&Care Products Co., Ltd.fc76c1f3-b48e-4276-890d-5b8e5a894e622024-04-01WarningsExact identifier
application number: M003
Novex Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.8b53dde5-c9f6-41c4-8ddb-bf0bf67008d32024-03-20WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE 0.13%Trifecta Pharmaceuticals USA, LLC.13f1c70f-3b44-8eef-e063-6294a90af6342024-03-18WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN877ce875-c5b0-4d9b-8f00-682914e3bc0e9
545626sodium monofluorophosphate 0.76 % ToothpastePSN877ce875-c5b0-4d9b-8f00-682914e3bc0e9
581660ethanol 0.62 ML/ML Topical GelSCD877ce875-c5b0-4d9b-8f00-682914e3bc0e9
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD877ce875-c5b0-4d9b-8f00-682914e3bc0e9
581660ethanol 62 % Topical GelSY877ce875-c5b0-4d9b-8f00-682914e3bc0e9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY877ce875-c5b0-4d9b-8f00-682914e3bc0e9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY877ce875-c5b0-4d9b-8f00-682914e3bc0e9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY877ce875-c5b0-4d9b-8f00-682914e3bc0e9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY877ce875-c5b0-4d9b-8f00-682914e3bc0e9
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
581660ethanol 62 % Topical GelPSN291eaa18-81f8-6907-e054-00144ff88e887
581660ethanol 0.62 ML/ML Topical GelSCD291eaa18-81f8-6907-e054-00144ff88e887
581660ethanol 62 % Topical GelSY291eaa18-81f8-6907-e054-00144ff88e887
581660ethanol 62 % Topical GelPSN7f1a85fd-086b-4fc7-abac-863dd3ea505a2
581660ethanol 62 % Topical GelPSN9df6d0e9-631c-4619-9d96-d2c5a32a590e2
581660ethanol 62 % Topical GelPSNf8369a27-1995-4fdd-a282-35c344c11d832
545626sodium monofluorophosphate 0.76 % ToothpastePSNf8369a27-1995-4fdd-a282-35c344c11d832
545626sodium monofluorophosphate 0.76 % ToothpastePSN9df6d0e9-631c-4619-9d96-d2c5a32a590e2
545626sodium monofluorophosphate 0.76 % ToothpastePSN7f1a85fd-086b-4fc7-abac-863dd3ea505a2
581660ethanol 0.62 ML/ML Topical GelSCD7f1a85fd-086b-4fc7-abac-863dd3ea505a2
581660ethanol 0.62 ML/ML Topical GelSCDf8369a27-1995-4fdd-a282-35c344c11d832
581660ethanol 0.62 ML/ML Topical GelSCD9df6d0e9-631c-4619-9d96-d2c5a32a590e2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD7f1a85fd-086b-4fc7-abac-863dd3ea505a2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDf8369a27-1995-4fdd-a282-35c344c11d832
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD9df6d0e9-631c-4619-9d96-d2c5a32a590e2
581660ethanol 62 % Topical GelSY7f1a85fd-086b-4fc7-abac-863dd3ea505a2
581660ethanol 62 % Topical GelSYf8369a27-1995-4fdd-a282-35c344c11d832
581660ethanol 62 % Topical GelSY9df6d0e9-631c-4619-9d96-d2c5a32a590e2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY7f1a85fd-086b-4fc7-abac-863dd3ea505a2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYf8369a27-1995-4fdd-a282-35c344c11d832
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY9df6d0e9-631c-4619-9d96-d2c5a32a590e2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY9df6d0e9-631c-4619-9d96-d2c5a32a590e2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY7f1a85fd-086b-4fc7-abac-863dd3ea505a2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYf8369a27-1995-4fdd-a282-35c344c11d832
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY9df6d0e9-631c-4619-9d96-d2c5a32a590e2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYf8369a27-1995-4fdd-a282-35c344c11d832
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY7f1a85fd-086b-4fc7-abac-863dd3ea505a2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY9df6d0e9-631c-4619-9d96-d2c5a32a590e2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYf8369a27-1995-4fdd-a282-35c344c11d832
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY7f1a85fd-086b-4fc7-abac-863dd3ea505a2
581660ethanol 62 % Topical GelPSN0143ea6d-8dde-4b6d-9b08-eaa27bbc270a1
545626sodium monofluorophosphate 0.76 % ToothpastePSN0143ea6d-8dde-4b6d-9b08-eaa27bbc270a1
581660ethanol 0.62 ML/ML Topical GelSCD0143ea6d-8dde-4b6d-9b08-eaa27bbc270a1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD0143ea6d-8dde-4b6d-9b08-eaa27bbc270a1
581660ethanol 62 % Topical GelSY0143ea6d-8dde-4b6d-9b08-eaa27bbc270a1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY0143ea6d-8dde-4b6d-9b08-eaa27bbc270a1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY0143ea6d-8dde-4b6d-9b08-eaa27bbc270a1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY0143ea6d-8dde-4b6d-9b08-eaa27bbc270a1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY0143ea6d-8dde-4b6d-9b08-eaa27bbc270a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-001-025944800010253 mL in 1 BOTTLE, PLASTIC (59448-001-02) 53 ml2015-12-180000-00-00NoNoCurrent