FDA.reportPublic FDA data

ETHYL ALCOHOL

Product NDC
59448-011
11-digit product format
594480011
Labeler code
59448
Product ID
59448-011_407eb059-1073-4a33-aaef-f964b4a98d87
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
ASP Global LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-02
Substance
ALCOHOL
Active strength
70 mL/100mL
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
ETHYL ALCOHOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 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
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
67a4b949-ce8a-4841-a965-fcc94165135cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-011-01ETHYL ALCOHOL53 mL in 1 BOTTLE, PLASTICGEL531
59448-011-01Northside Hospital Maternity Backpack BASE53 mL in 1 BOTTLE, PLASTICGEL53 mL70 mL in 100mL1
59448-011-01Northside Hospital Maternity Backpack-BASE53 mL in 1 BOTTLE, PLASTICGEL53 mL70 mL in 100mL1
59448-011-01Northside Hospital Mothers Kit, Grey Backpack53 mL in 1 BOTTLE, PLASTICGEL53 mL70 mL in 100mL1
59448-011-01Northside Hospital Grey Amenity Kit53 mL in 1 BOTTLE, PLASTICGEL53 mL70 mL in 100mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-011ETHYL ALCOHOL (ALCOHOL) GEL [ASP GLOBAL LLC]1Current NDC, 1 package rows20250406_67a4b949-ce8a-4841-a965-fcc94165135c.zip
59448-011NORTHSIDE HOSPITAL GREY AMENITY KIT (SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL, LLC]1Current NDC20250426_a3cc89df-be1b-4d9a-8ba3-857885325422.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 54 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadsISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD43401653-b260-e86d-e063-6294a90abb3f2025-11-13WarningsExact identifier
application number: M003
CVS Health Isopropyl Rubbing Alcohol PadsISOPROPYL ALCOHOLCVS Healthc8d4f3b3-166c-2411-e053-2a95a90abb4a2025-11-12WarningsExact identifier
application number: M003
PetroleumWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)e3100877-6261-4502-8db8-d8ae3af6cd792025-11-12WarningsExact identifier
application number: M003
PetroleumWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)c65ddc74-4666-457d-91bd-138143446bbe2025-11-12WarningsExact identifier
application number: M003
Dr Lift Antibacterial Hand SanitizerETHYL ALCOHOLSpa de Soleilaba006cd-18db-e42f-e053-2995a90a46072025-11-12WarningsExact identifier
application number: M003
Recovery Antiseptic Skin PrepCHLOROXYLENOLPURKLENZ FORMULATIONS INC.94c5ea07-6bdb-42c6-8ce0-0d0711bd70362025-11-12WarningsExact identifier
application number: M003
PurKlenzCHLOROXYLENOLPurKlenz Formulations Inc.9f1223a8-a256-46f0-b01d-01b32ca09d482025-11-12WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Lemon SorbetALCOHOLShenzhen Lantern Scicence Co.,Ltd.434d3071-802b-f598-e063-6394a90a622d2025-11-11WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Strawberry ShortcakeALCOHOLShenzhen Lantern Scicence Co.,Ltd.434d5f7c-f84d-d6f5-e063-6294a90aa6fe2025-11-11WarningsExact identifier
application number: M003
Walgreens Hand Sanitizer PearALCOHOLShenzhen Lantern Scicence Co.,Ltd.434ddef3-fe48-138d-e063-6394a90afc912025-11-11WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd9884b7-6df3-5ece-e053-2a95a90ab20e2025-11-11WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd8643ef-dc83-8bc1-e053-2995a90a007b2025-11-11WarningsExact identifier
application number: M003
Betadine Solution SwabsticksPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.0707b259-52a4-4ae6-b176-d093865906e72025-11-11WarningsExact identifier
application number: M003
Walgreens Hand Sanitizer Sweet PeaALCOHOLShenzhen Lantern Scicence Co.,Ltd.435ca082-0b6b-c55e-e063-6294a90af56e2025-11-11WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.435d514e-204a-118b-e063-6294a90aa8a62025-11-11WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Spider-manALCOHOLShenzhen Lantern Scicence Co.,Ltd.435d939c-9bef-bf86-e063-6394a90a41422025-11-11WarningsExact identifier
application number: M003
Foaming Hand SanitizerHAND SANITIZERAmerican Chemical Systems II, LLC3085d595-68b7-4100-81c0-f0699a7609d62025-11-10WarningsExact identifier
application number: M003
Genuine First Aid Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.48867a79-4d21-4ba1-9cf9-7839352a4b7e2025-11-07WarningsExact identifier
application number: M003
Pocket NurseISOPROPYL ALCOHOLPocket Nurse Enterprises, LLC42ded32e-15d9-8b03-e063-6394a90ad6bc2025-11-06WarningsExact identifier
application number: M003
SMARTIES ORANGE HAND SANITIZER MIX BERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d5785f-a86b-47fb-e063-6294a90a73142025-11-05WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN67a4b949-ce8a-4841-a965-fcc94165135c1
581662ethanol 70 % Topical GelPSN5d0e768f-086c-4b8c-b618-6dde70f302f91
581662ethanol 70 % Topical GelPSN86458169-92eb-45a5-b3cc-6eccd8caa1e81
581662ethanol 70 % Topical GelPSNa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethanol 70 % Topical GelPSN0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.76 % ToothpastePSN0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.76 % ToothpastePSN5d0e768f-086c-4b8c-b618-6dde70f302f91
545626sodium monofluorophosphate 0.76 % ToothpastePSN86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % ToothpastePSNa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethanol 0.7 ML/ML Topical GelSCDa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethanol 0.7 ML/ML Topical GelSCD0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
581662ethanol 0.7 ML/ML Topical GelSCD86458169-92eb-45a5-b3cc-6eccd8caa1e81
581662ethanol 0.7 ML/ML Topical GelSCD5d0e768f-086c-4b8c-b618-6dde70f302f91
581662ethanol 0.7 ML/ML Topical GelSCD67a4b949-ce8a-4841-a965-fcc94165135c1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD5d0e768f-086c-4b8c-b618-6dde70f302f91
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethanol 70 % Topical GelSYa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethanol 70 % Topical GelSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
581662ethanol 70 % Topical GelSY67a4b949-ce8a-4841-a965-fcc94165135c1
581662ethanol 70 % Topical GelSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
581662ethanol 70 % Topical GelSY5d0e768f-086c-4b8c-b618-6dde70f302f91
581662ethyl alcohol 70 % Topical GelSYa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethyl alcohol 70 % Topical GelSY67a4b949-ce8a-4841-a965-fcc94165135c1
581662ethyl alcohol 70 % Topical GelSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
581662ethyl alcohol 70 % Topical GelSY5d0e768f-086c-4b8c-b618-6dde70f302f91
581662ethyl alcohol 70 % Topical GelSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY5d0e768f-086c-4b8c-b618-6dde70f302f91
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY5d0e768f-086c-4b8c-b618-6dde70f302f91
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY5d0e768f-086c-4b8c-b618-6dde70f302f91
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY5d0e768f-086c-4b8c-b618-6dde70f302f91
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59448-011-015944800110153 mL in 1 BOTTLE, PLASTIC (59448-011-01) 53 ml2025-04-01NoNoCurrent