Enriched Foam Alcohol-Free Hand Sanitizer

Product NDC
65321-039
11-digit product format
653210039
Labeler code
65321
Product ID
65321-039_3dc6fc3f-10d2-48b0-8437-7d688ae7bebc
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Rubbermaid Commercial Products LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-21
Substance
BENZALKONIUM CHLORIDE
Active strength
13 mg/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 22 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 2025-12-0565321-039-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0565321-039-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2665321-039-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2665321-039-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3165321-039-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3165321-039-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2865321-039-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2865321-039-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2165321-039-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2165321-039-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1065321-039-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1065321-039-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3165321-039-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3165321-039-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2065321-039-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2065321-039-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1065321-039-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1065321-039-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0865321-039-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0865321-039-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0365321-039-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0365321-039-03367a005e9d99…383a685ebd0f…

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
Enriched Foam Alcohol-Free Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE13 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020365Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a6456aa-69f7-476b-afbb-3dd69377e8b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65321-039-01Enriched Foam Alcohol-Free Hand Sanitizer1100 mL in 1 POUCHLIQUID11006
65321-039-01Enriched Foam Alcohol-Free Hand Sanitizer4 in 1 BOXLIQUID46
65321-039-02Enriched Foam Alcohol-Free Hand Sanitizer4 in 1 BOXLIQUID46
65321-039-02Enriched Foam Alcohol-Free Hand Sanitizer1300 mL in 1 POUCHLIQUID13006
65321-039-03Enriched Foam Alcohol-Free Hand Sanitizer800 mL in 1 POUCHLIQUID8006
65321-039-03Enriched Foam Alcohol-Free Hand Sanitizer6 in 1 BOXLIQUID66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65321-039ENRICHED FOAM ALCOHOL-FREE HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [RUBBERMAID COMMERCIAL PRODUCTS LLC]6Current NDC, Legacy NDC, 6 package rows20240929_0a6456aa-69f7-476b-afbb-3dd69377e8b2.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
Enriched Foam Alcohol-Free Hand SanitizerBENZALKONIUM CHLORIDERubbermaid Commercial Products LLC0a6456aa-69f7-476b-afbb-3dd69377e8b22026-06-05WarningsExact identifier
ndc (product): 65321-039

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN0a6456aa-69f7-476b-afbb-3dd69377e8b26
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD0a6456aa-69f7-476b-afbb-3dd69377e8b26
1020365benzalkonium chloride 0.13 % Topical FoamSY0a6456aa-69f7-476b-afbb-3dd69377e8b26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65321-039-01653210039014 POUCH in 1 BOX (65321-039-01) / 1100 mL in 1 POUCH4 pouch2021-06-210000-00-00NoNoCurrent
65321-039-02653210039024 POUCH in 1 BOX (65321-039-02) > 1300 mL in 1 POUCH4 pouch2021-06-210000-00-00NoNoCurrent
65321-039-03653210039036 POUCH in 1 BOX (65321-039-03) > 800 mL in 1 POUCH6 pouch2021-06-210000-00-00NoNoCurrent