FDA.reportPublic FDA data

Natural Concepts Vitamin E Hand Sanitizer

Product NDC
63148-510
Requested package NDC
63148-510-03
11-digit product format
631480510
Labeler code
63148
Product ID
63148-510_aa153885-8056-45b2-a6d3-3be9db915f37
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Apollo Health and Beauty Care Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-16
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
650 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage63148-51063148-510-03IInactivated by FDA2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDCIndexing SPLRelated label
63148-510-031030e365-3175-111a-e063-dadaa90a10e2Drug Facts
63148-510-081030e365-42b5-111a-e063-dadaa90a10e2Drug Facts Box
63148-510-091030e365-3175-111a-e063-dadaa90a10e2Drug Facts
63148-510-321030e365-50c7-111a-e063-dadaa90a10e2Drug Facts
63148-510-331030e365-3175-111a-e063-dadaa90a10e2Drug Facts
63148-510-401030e365-50c7-111a-e063-dadaa90a10e2Drug Facts
63148-510-411030e365-3175-111a-e063-dadaa90a10e2Drug Facts
63148-510-641030e365-50c7-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-510-32Natural Concepts Vitamin E Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9463
63148-510-40Natural Concepts Vitamin E Hand Sanitizer1182 mL in 1 BOTTLE, PLASTICGEL11823
63148-510-64Natural Concepts Vitamin E Hand Sanitizer1893 mL in 1 BOTTLE, PLASTICGEL18933
63148-510-08Natural Concepts Vitamin E Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2362
63148-510-03Natural Concepts Vitamin E Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591
63148-510-09Natural Concepts Vitamin E Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361
63148-510-33Natural Concepts Vitamin E Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9461
63148-510-41Natural Concepts Vitamin E Hand Sanitizer1182 mL in 1 BOTTLE, PLASTICGEL11821

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-510NATURAL CONCEPTS VITAMIN E HAND SANITIZER (ETHYL ALCOHOL) GEL [APOLLO HEALTH AND BEAUTY CARE INC.]3Legacy NDC, 3 package rows20200331_eb89ec43-e0d6-4fd5-906e-65258e73dfb0.zip
63148-510NATURAL CONCEPTS VITAMIN E HAND SANITIZER (ETHYL ALCOHOL) GEL [APOLLO HEALTH AND BEAUTY CARE INC.]2Legacy NDC, 1 package rows20200331_33e12c9b-8bf8-4ce2-b21c-3399930f2215.zip
63148-510NATURAL CONCEPTS VITAMIN E HAND SANITIZER (ETHYL ALCOHOL) GEL [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 4 package rows20200317_e2fba421-badb-4d87-aec4-01a36828bbde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902574ethanol 65 % Topical GelPSNeb89ec43-e0d6-4fd5-906e-65258e73dfb03
902574ethanol 0.65 ML/ML Topical GelSCDeb89ec43-e0d6-4fd5-906e-65258e73dfb03
902574ethyl alcohol 65 % Topical GelSYeb89ec43-e0d6-4fd5-906e-65258e73dfb03
902574ethanol 65 % Topical GelPSN33e12c9b-8bf8-4ce2-b21c-3399930f22152
902574ethanol 0.65 ML/ML Topical GelSCD33e12c9b-8bf8-4ce2-b21c-3399930f22152
902574ethyl alcohol 65 % Topical GelSY33e12c9b-8bf8-4ce2-b21c-3399930f22152
902574ethanol 65 % Topical GelPSNe2fba421-badb-4d87-aec4-01a36828bbde1
902574ethanol 0.65 ML/ML Topical GelSCDe2fba421-badb-4d87-aec4-01a36828bbde1
902574ethyl alcohol 65 % Topical GelSYe2fba421-badb-4d87-aec4-01a36828bbde1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63148-510-036314805100359 mL in 1 BOTTLE, PLASTIC (63148-510-03) 59 ml2020-03-160000-00-00NoNoCurrent