Optimize Thick Hand Sanitizer

Product NDC
68400-486
Requested package NDC
68400-486-06
11-digit product format
684000486
Labeler code
68400
Product ID
68400-486_2905aaa8-b229-4705-e063-6294a90ac696
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-30
Marketing end
2027-02-19
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
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 packagepackage68400-48668400-486-06IInactivated by FDA2026-08-11

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 2025-12-05IInactivated 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…

Additional Listing Data#

Finished product
Yes
Brand name base
Optimize Thick Hand Sanitizer

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a35b9348-c35f-7ba9-e053-2995a90a4a30Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68400-486-15Optimize Thick Hand Sanitizer473.2 mL in 1 BOTTLE, PLASTICGEL473.23
68400-486-01Optimize Thick Hand Sanitizer3780 mL in 1 BOTTLE, PLASTICGEL37802
68400-486-06Optimize Thick Hand Sanitizer177.4 mL in 1 BOTTLE, PLASTICGEL177.42
68400-486-16Optimize Thick Hand Sanitizer473.2 mL in 1 BOTTLE, PLASTICGEL473.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-486OPTIMIZE THICK HAND SANITIZER (ALCOHOL) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]3Current NDC, Legacy NDC, 1 package rows20241222_a35b9348-c35f-7ba9-e053-2995a90a4a30.zip
68400-486OPTIMIZE THICK HAND SANITIZER (ALCOHOL) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]2Current NDC, Legacy NDC, 1 package rows20220126_a35b4c73-d4b7-6a2a-e053-2a95a90adade.zip
68400-486OPTIMIZE THICK HAND SANITIZER (ALCOHOL) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]2Current NDC, Legacy NDC, 1 package rows20220126_a8d8f046-b2e4-b15f-e053-2a95a90abbe3.zip
68400-486OPTIMIZE THICK HAND SANITIZER (ALCOHOL) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]2Current NDC, Legacy NDC, 1 package rows20220126_a3570f9a-dab5-1f9a-e053-2a95a90ab077.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
Optimize Thick Hand SanitizerALCOHOLMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inca35b9348-c35f-7ba9-e053-2995a90a4a302024-12-11WarningsExact identifier
ndc (product): 68400-486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68400-486-0668400048606177.4 mL in 1 BOTTLE, PLASTIC (68400-486-06) 177.4 ml2020-04-010000-00-00NoNoCurrent