Natural Concepts Hand Sanitizer

Product NDC
63148-516
Requested package NDC
63148-516-11
11-digit product format
631480516
Labeler code
63148
Product ID
63148-516_513b7d15-7d64-3775-e063-6394a90adf9c
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Apollo Health and Beauty Care
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-11
Substance
ALCOHOL
Active strength
650 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63148-51663148-516-11DDiscontinued by firm2026-08-11

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, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Natural Concepts Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL650 mg/mL

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
902574Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b25bbf28-f08d-4de2-9be7-bfb6b134b49aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-516-03Natural Concepts Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL595
63148-516-09Natural Concepts Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2365
63148-516-33Natural Concepts Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9465

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-516NATURAL CONCEPTS HAND SANITIZER (ETHYL ALCOHOL) GEL [APOLLO HEALTH AND BEAUTY CARE INC.]2Current NDC, Legacy NDC, 3 package rows20250203_b25bbf28-f08d-4de2-9be7-bfb6b134b49a.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
Natural Concepts Hand SanitizerETHYL ALCOHOLApollo Health and Beauty Careb25bbf28-f08d-4de2-9be7-bfb6b134b49a2026-05-07WarningsExact identifier
ndc (product): 63148-516

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902574ethanol 65 % Topical GelPSNb25bbf28-f08d-4de2-9be7-bfb6b134b49a5
902574ethanol 0.65 ML/ML Topical GelSCDb25bbf28-f08d-4de2-9be7-bfb6b134b49a5
902574ethyl alcohol 65 % Topical GelSYb25bbf28-f08d-4de2-9be7-bfb6b134b49a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63148-516-11631480516113785 mL in 1 BOTTLE, PLASTIC (63148-516-11) 3785 ml2020-06-230000-00-00NoNoCurrent