FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
49687-0015
11-digit product format
496870015
Labeler code
49687
Product ID
49687-0015_2b9b7e7d-a481-efea-e063-6294a90ab93d
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
CMC Group Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-08
Substance
ALCOHOL
Active strength
.62 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.62 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581660

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49687-0015-02025-01-14C16284748780-11030e364-fd2e-111a-e063-dadaa90a10e2Hand Sanitizer
49687-0015-12025-01-14C16284748780-11030e364-fd2e-111a-e063-dadaa90a10e2Hand Sanitizer
49687-0015-02024-01-30C16284748780-11030e364-fd2e-111a-e063-dadaa90a10e2Hand Sanitizer
49687-0015-12024-01-30C16284748780-11030e364-fd2e-111a-e063-dadaa90a10e2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49687-0015-1Large ANSI First Aid Kit0.9 g in 1 PACKAGEGEL5.4 g0.62 g in 1g15
49687-0015-1Large ANSI First Aid Kit6 in 1 BOXGEL0.62 g in 1g15
49687-0015-1Standard ANSI First Aid6 in 1 BOXGEL0.62 g in 1g13
49687-0015-1Standard ANSI First Aid0.9 g in 1 PACKAGEGEL5.4 g0.62 g in 1g13
49687-0015-0Refill 60.9 g in 1 BOTTLEGEL5.4 g0.62 g in 1g11
49687-0015-0Refill 66 in 1 KITGEL0.62 g in 1g11
49687-0015-0Hand Sanitizer0.9 g in 1 BOTTLEGEL0.95
49687-0015-0Hand Sanitizer6 in 1 KITGEL65
49687-0015-1Hand Sanitizer0.9 g in 1 PACKAGEGEL0.95
49687-0015-1Hand Sanitizer6 in 1 BOXGEL65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49687-0015LARGE ANSI FIRST AID KIT (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [CMC GROUP, INC.]15Current NDC, Legacy NDC20250406_fa8578c2-a0bc-4e2e-a4f9-d48debfff378.zip
49687-0015STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [CMC GROUP, INC.]13Current NDC, Legacy NDC20250406_e1ef74bf-8895-4200-a411-f726dcdaa945.zip
49687-0015REFILL 6 (ALCOHOL, WATER) KIT [CMC GROUP, INC.]11Current NDC, Legacy NDC20250115_7849ae59-5484-4b86-a0b9-ec9b93d9afe0.zip
49687-0015HAND SANITIZER (ALCOHOL) GEL [CMC GROUP INC.]5Current NDC, Legacy NDC, 4 package rows20250116_dcca50e6-0935-401d-a23e-be4d1231dde9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 % Medicated PadPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
581660ethanol 62 % Topical GelPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Medicated PadPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.1 % Ophthalmic Irrigation SolutionPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
581660ethanol 0.62 ML/ML Topical GelSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 991 MG/ML Ophthalmic Irrigation SolutionSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 % Topical ClothSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 % Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
581660ethanol 62 % Topical GelSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Medicated PadSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Topical ClothSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.05 % Ophthalmic Irrigation SolutionSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.1 % Ophthalmic Irrigation SolutionSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.1 ML per 100 ML Ophthalmic Irrigation SolutionSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 % Medicated PadPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
581660ethanol 62 % Topical GelPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Medicated PadPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.1 % Ophthalmic Irrigation SolutionPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
581660ethanol 0.62 ML/ML Topical GelSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 991 MG/ML Ophthalmic Irrigation SolutionSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 % Topical ClothSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 % Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
581660ethanol 62 % Topical GelSYe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Medicated PadSYe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Topical ClothSYe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.05 % Ophthalmic Irrigation SolutionSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.1 % Ophthalmic Irrigation SolutionSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.1 ML per 100 ML Ophthalmic Irrigation SolutionSYe1ef74bf-8895-4200-a411-f726dcdaa94513
581660ethanol 62 % Topical GelPSN7849ae59-5484-4b86-a0b9-ec9b93d9afe011
1053429water 99.1 % Ophthalmic Irrigation SolutionPSN7849ae59-5484-4b86-a0b9-ec9b93d9afe011
581660ethanol 0.62 ML/ML Topical GelSCD7849ae59-5484-4b86-a0b9-ec9b93d9afe011
1053429water 991 MG/ML Ophthalmic Irrigation SolutionSCD7849ae59-5484-4b86-a0b9-ec9b93d9afe011
581660ethanol 62 % Topical GelSY7849ae59-5484-4b86-a0b9-ec9b93d9afe011
1053429water 99.05 % Ophthalmic Irrigation SolutionSY7849ae59-5484-4b86-a0b9-ec9b93d9afe011
1053429water 99.1 % Ophthalmic Irrigation SolutionSY7849ae59-5484-4b86-a0b9-ec9b93d9afe011
1053429water 99.1 ML per 100 ML Ophthalmic Irrigation SolutionSY7849ae59-5484-4b86-a0b9-ec9b93d9afe011
581660ethanol 62 % Topical GelPSNdcca50e6-0935-401d-a23e-be4d1231dde95
581660ethanol 0.62 ML/ML Topical GelSCDdcca50e6-0935-401d-a23e-be4d1231dde95
581660ethanol 62 % Topical GelSYdcca50e6-0935-401d-a23e-be4d1231dde95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49687-0015-0496870015000.9 g in 1 BOTTLE0.9 gHistorical
49687-0015-1496870015016 PACKAGE in 1 BOX (49687-0015-1) / .9 g in 1 PACKAGE6 package2016-08-080000-00-00NoNoCurrent