FDA.reportPublic FDA data

Premium Foam Antibacterial

Product NDC
21749-085
Requested package NDC
21749-085-80
11-digit product format
217490085
Labeler code
21749
Product ID
21749-085_38f391e9-d574-c58f-e063-6294a90a58ef
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
LIQUID
Route
TOPICAL
Labeler
GOJO Industries, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-11
Substance
CHLOROXYLENOL
Active strength
.003 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage21749-08521749-085-80DDiscontinued by firm2026-08-17

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, 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…

Additional Listing Data#

Finished product
Yes
Brand name base
Premium Foam Antibacterial
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL.003 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0F32U78V2QInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9863ec0b-4005-4bf2-a114-952331508d82Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
21749-085-232023-08-01GOJO Premium Foam Antibacterial Handwash
21749-085-462023-08-01GOJO Premium Foam Antibacterial Handwash
21749-085-802023-08-01GOJO Premium Foam Antibacterial Handwash
21749-085-892023-08-01GOJO Premium Foam Antibacterial Handwash
21749-085-232023-07-28GOJO Premium Foam Antibacterial Handwash
21749-085-462023-07-28GOJO Premium Foam Antibacterial Handwash
21749-085-802023-07-28GOJO Premium Foam Antibacterial Handwash
21749-085-892023-07-28GOJO Premium Foam Antibacterial Handwash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21749-085-23Premium Foam Antibacterial222 mL in 1 BOTTLELIQUID2226
21749-085-46Premium Foam Antibacterial1360 mL in 1 BOTTLELIQUID13606
21749-085-80Premium Foam Antibacterial800 mL in 1 BOTTLELIQUID8006
21749-085-89Premium Foam Antibacterial1200 mL in 1 BOTTLELIQUID12006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROXYLENOLACTIVE INGREDIENT0F32U78V2QPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
AMMONIUM LAURETH-2 SULFATEINACTIVE INGREDIENT698O4Z48G6PREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0BPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
AMMONIUM SULFATEINACTIVE INGREDIENTSU46BAM238PREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
AMMONIUM XYLENESULFONATEINACTIVE INGREDIENT4FZY6L6XCMPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
CORN OILINACTIVE INGREDIENT8470G57WFMPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21749-085PREMIUM FOAM ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]5Current NDC, Legacy NDC, 4 package rows20241123_9863ec0b-4005-4bf2-a114-952331508d82.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
Premium Foam AntibacterialCHLOROXYLENOLGOJO Industries, Inc.9863ec0b-4005-4bf2-a114-952331508d822025-07-02WarningsExact identifier
ndc (package): 21749-085-80
ndc (product): 21749-085
ndc11 (package): 21749008580

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21749-085-8021749008580800 mL in 1 BOTTLE (21749-085-80) 800 ml2012-01-110000-00-00NoNoCurrent