FDA.reportPublic FDA data

XALIX

Product NDC
52187-525
11-digit product format
521870525
Labeler code
52187
Product ID
52187-525_5c60df47-58d0-5226-e053-2a91aa0a1646
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
SOLUTION
Route
TOPICAL
Labeler
KMM Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-10-25
Substance
SALICYLIC ACID
Active strength
280 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XALIX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID280 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1986360Internal RxNorm lookup
1986365Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c60df47-58cf-5226-e053-2a91aa0a1646Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52187-525-10XALIX1 in 1 CARTONSOLUTION11
52187-525-10XALIX10 g in 1 BOTTLE, WITH APPLICATORSOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52187-525-10GM - Gram52187-525b53ae185-5835-49db-84f4-64a75e15d6cb12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52187-525XALIX (SALICYLIC ACID) SOLUTION [KMM PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 2 package rows20171025_5c60df47-58cf-5226-e053-2a91aa0a1646.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
XALIXSALICYLIC ACIDKMM Pharmaceuticals, LLC5c60df47-58cf-5226-e053-2a91aa0a16462017-10-25Warnings, Adverse reactionsExact identifier
ndc (product): 52187-525

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1986360salicylic acid 28 % Topical SolutionPSN5c60df47-58cf-5226-e053-2a91aa0a16461
1986365XALIX 28 % Topical SolutionPSN5c60df47-58cf-5226-e053-2a91aa0a16461
1986365salicylic acid 280 MG/ML Topical Solution [Xalix]SBD5c60df47-58cf-5226-e053-2a91aa0a16461
1986360salicylic acid 280 MG/ML Topical SolutionSCD5c60df47-58cf-5226-e053-2a91aa0a16461
1986360salicylic acid 28 % Topical SolutionSY5c60df47-58cf-5226-e053-2a91aa0a16461
1986365Xalix 280 MG/ML Topical SolutionSY5c60df47-58cf-5226-e053-2a91aa0a16461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52187-525-10521870525101 BOTTLE, WITH APPLICATOR in 1 CARTON (52187-525-10) / 10 g in 1 BOTTLE, WITH APPLICATOR2017-10-250000-00-00NoNoCurrent