MELLOW HAND SANITIZER ALOE

Product NDC
77725-005
Requested package NDC
77725-005-81
11-digit product format
777250005
Labeler code
77725
Product ID
77725-005_04d905d9-2a9c-49a4-a76b-55c68f05159c
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
L.e.d. Cosmetics, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-06
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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…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
MELLOW HAND SANITIZER ALOE
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
582753Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4377ba5e-21f6-407e-9b8c-25e3c6321a5bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77725-005-17MELLOW HAND SANITIZER ALOE500 mL in 1 BOTTLE, PLASTICLIQUID5002
77725-005-81MELLOW HAND SANITIZER ALOE236 mL in 1 BOTTLE, PLASTICLIQUID2362
77725-005-82MELLOW HAND SANITIZER ALOE236 mL in 1 BOTTLE, PLASTICLIQUID2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77725-005MELLOW HAND SANITIZER ALOE (ETHYL ALCOHOL) LIQUID [L.E.D. COSMETICS, INC.]2Current NDC, Legacy NDC, 3 package rows20241212_4377ba5e-21f6-407e-9b8c-25e3c6321a5b.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
MELLOW HAND SANITIZER ALOEETHYL ALCOHOLL.e.d. Cosmetics, Inc.4377ba5e-21f6-407e-9b8c-25e3c6321a5b2024-12-10WarningsExact identifier
ndc (package): 77725-005-81
ndc (product): 77725-005
ndc11 (package): 77725000581

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSN4377ba5e-21f6-407e-9b8c-25e3c6321a5b2
582753ethanol 0.7 ML/ML Topical SolutionSCD4377ba5e-21f6-407e-9b8c-25e3c6321a5b2
582753ethanol 70 % Topical SolutionSY4377ba5e-21f6-407e-9b8c-25e3c6321a5b2
582753ethyl alcohol 70 % Topical SolutionSY4377ba5e-21f6-407e-9b8c-25e3c6321a5b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77725-005-8177725000581236 mL in 1 BOTTLE, PLASTIC (77725-005-81) 236 ml2020-08-060000-00-00NoNoCurrent