FDA.reportPublic FDA data

Natural Concepts Alcohol-Free Hand Sanitizer

Product NDC
63148-512
Requested package NDC
63148-512-03
11-digit product format
631480512
Labeler code
63148
Product ID
63148-512_efe575ac-5c02-4ff5-8477-fa809af856ce
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
GEL
Route
TOPICAL
Labeler
Apollo Health and Beauty Care Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-16
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 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 packagepackage63148-51263148-512-03IInactivated by FDA2026-10-12

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 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDCIndexing SPLRelated label
63148-512-022cef2736-85c2-d83d-e063-dadaa90ab31fDrug Facts
63148-512-032cef2736-6a69-d83d-e063-dadaa90ab31fDrug Facts
63148-512-042cef2736-63f4-d83d-e063-dadaa90ab31fDrug Facts
63148-512-082cef2736-85c2-d83d-e063-dadaa90ab31fDrug Facts
63148-512-092cef2736-6a69-d83d-e063-dadaa90ab31fDrug Facts
63148-512-102cef2736-63f4-d83d-e063-dadaa90ab31fDrug Facts
63148-512-322cef2736-85c2-d83d-e063-dadaa90ab31fDrug Facts
63148-512-332cef2736-6a69-d83d-e063-dadaa90ab31fDrug Facts
63148-512-342cef2736-63f4-d83d-e063-dadaa90ab31fDrug Facts
63148-512-372cef2736-7b19-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-512-02Natural Concepts Alcohol-Free Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591
63148-512-03Natural Concepts Alcohol-Free Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591
63148-512-04Natural Concepts Alcohol-Free Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591
63148-512-08Natural Concepts Alcohol-Free Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361
63148-512-09Natural Concepts Alcohol-Free Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361
63148-512-10Natural Concepts Alcohol-Free Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361
63148-512-32Natural Concepts Alcohol-Free Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9461
63148-512-33Natural Concepts Alcohol-Free Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9461
63148-512-34Natural Concepts Alcohol-Free Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9461
63148-512-37Natural Concepts Alcohol-Free Hand Sanitizer3785 mL in 1 PACKAGEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-512NATURAL CONCEPTS ALCOHOL-FREE HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 3 package rows20200416_147ef8cf-6920-4812-9e42-8aeb01a239b6.zip
63148-512NATURAL CONCEPTS ALCOHOL-FREE HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 3 package rows20200416_272ba05c-22eb-43a9-964b-359012f67aab.zip
63148-512NATURAL CONCEPTS ALCOHOL-FREE HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 3 package rows20200416_51035580-96ab-4706-8498-5c9491eacad7.zip
63148-512NATURAL CONCEPTS ALCOHOL-FREE HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 1 package rows20200718_b2beed06-ee8c-4f26-9afe-cc8b3b179a37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098199benzalkonium chloride 0.13 % Topical GelPSN147ef8cf-6920-4812-9e42-8aeb01a239b61
1098199benzalkonium chloride 0.13 % Topical GelPSN272ba05c-22eb-43a9-964b-359012f67aab1
1098199benzalkonium chloride 0.13 % Topical GelPSN51035580-96ab-4706-8498-5c9491eacad71
1098199benzalkonium chloride 0.13 % Topical GelPSNb2beed06-ee8c-4f26-9afe-cc8b3b179a371
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD147ef8cf-6920-4812-9e42-8aeb01a239b61
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD272ba05c-22eb-43a9-964b-359012f67aab1
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD51035580-96ab-4706-8498-5c9491eacad71
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCDb2beed06-ee8c-4f26-9afe-cc8b3b179a371
1098199benzalkonium chloride 0.13 % Topical GelSY147ef8cf-6920-4812-9e42-8aeb01a239b61
1098199benzalkonium chloride 0.13 % Topical GelSY272ba05c-22eb-43a9-964b-359012f67aab1
1098199benzalkonium chloride 0.13 % Topical GelSY51035580-96ab-4706-8498-5c9491eacad71
1098199benzalkonium chloride 0.13 % Topical GelSYb2beed06-ee8c-4f26-9afe-cc8b3b179a371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63148-512-036314805120359 mL in 1 BOTTLE, PLASTIC (63148-512-03) 59 ml2020-04-140000-00-00NoNoCurrent