Advanced Hand Sanitizer

Product NDC
63868-882
11-digit product format
638680882
Labeler code
63868
Product ID
63868-882_4b2ead80-aa6c-638a-e063-6394a90a4c9c
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Chain Drug Marketing Association
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-05
Substance
ALCOHOL
Active strength
70 mL/100mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63868-88263868-882-16DDiscontinued by firm2026-10-05
excluded packagepackage63868-88263868-882-43DDiscontinued by firm2026-10-05
excluded packagepackage63868-88263868-882-45DDiscontinued by firm2026-10-05

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 · 6 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0563868-882-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0563868-882-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0563868-882-43d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2663868-882-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2663868-882-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2663868-882-43f5e01cc5f278…a2eaf40c39c3…

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
Advanced Hand Sanitizer
Listing expiration
2027-12-31

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
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a85d93f2-e6f0-4fad-9ff7-6cbb62942bb2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-882-16Advanced Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL598
63868-882-34Advanced Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2368
63868-882-43Advanced Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4738
63868-882-45Advanced Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9468

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-882ADVANCED HAND SANITIZER (ALCOHOL) GEL [CDMA]6Current NDC, Legacy NDC, 4 package rows20240929_a85d93f2-e6f0-4fad-9ff7-6cbb62942bb2.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
Advanced Hand SanitizerALCOHOLChain Drug Marketing Associationa85d93f2-e6f0-4fad-9ff7-6cbb62942bb22026-02-19Warnings, Adverse reactionsExact identifier
ndc (product): 63868-882

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa85d93f2-e6f0-4fad-9ff7-6cbb62942bb28
581662ethanol 0.7 ML/ML Topical GelSCDa85d93f2-e6f0-4fad-9ff7-6cbb62942bb28
581662ethanol 70 % Topical GelSYa85d93f2-e6f0-4fad-9ff7-6cbb62942bb28
581662ethyl alcohol 70 % Topical GelSYa85d93f2-e6f0-4fad-9ff7-6cbb62942bb28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-882-166386808821659 mL in 1 BOTTLE, PLASTIC (63868-882-16) 59 ml2021-10-050000-00-00NoNoCurrent
63868-882-3463868088234236 mL in 1 BOTTLE, PLASTIC (63868-882-34) 236 ml2021-10-050000-00-00NoNoCurrent
63868-882-4363868088243473 mL in 1 BOTTLE, PLASTIC (63868-882-43) 473 ml2021-10-050000-00-00NoNoCurrent
63868-882-4563868088245946 mL in 1 BOTTLE, PLASTIC (63868-882-45) 946 ml2021-10-050000-00-00NoNoCurrent