QUALITY CHOICE INSTANT HAND SANITIZER

Product NDC
77725-004
11-digit product format
777250004
Labeler code
77725
Product ID
77725-004_cefb87b4-4851-4268-ad0d-bebe7d1bdb43
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
L.e.d. Cosmetics, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-04
Substance
ALCOHOL
Active strength
70 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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage77725-004-08fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage77725-004-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage77725-004-08bd6a592717d7…303034d00443…

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
QUALITY CHOICE INSTANT HAND SANITIZER
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
ec37da5a-8ef7-474b-a5ec-b5edcee03f9dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77725-004-08QUALITY CHOICE INSTANT HAND SANITIZER236 mL in 1 BOTTLE, PLASTICGEL2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77725-004QUALITY CHOICE INSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [L.E.D. COSMETICS, INC.]3Current NDC, Legacy NDC, 1 package rows20241212_ec37da5a-8ef7-474b-a5ec-b5edcee03f9d.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUALITY CHOICE INSTANT HAND SANITIZERETHYL ALCOHOLL.e.d. Cosmetics, Inc.ec37da5a-8ef7-474b-a5ec-b5edcee03f9d2024-12-10WarningsExact identifier
ndc (product): 77725-004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNec37da5a-8ef7-474b-a5ec-b5edcee03f9d3
581662ethanol 0.7 ML/ML Topical GelSCDec37da5a-8ef7-474b-a5ec-b5edcee03f9d3
581662ethanol 70 % Topical GelSYec37da5a-8ef7-474b-a5ec-b5edcee03f9d3
581662ethyl alcohol 70 % Topical GelSYec37da5a-8ef7-474b-a5ec-b5edcee03f9d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77725-004-0877725000408236 mL in 1 BOTTLE, PLASTIC (77725-004-08) 236 ml2020-08-040000-00-00NoNoCurrent