FDA.reportPublic FDA data

XALIX

Product NDC
24470-947
11-digit product format
244700947
Labeler code
24470
Product ID
24470-947_41369805-8394-c804-e063-6394a90a0440
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Cintex Services, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-10-20
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
41369b38-7f15-b597-e063-6394a90a614bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24470-947-10XALIX10 g in 1 BOTTLE, WITH APPLICATORSOLUTION101
24470-947-10XALIX1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24470-947-10GM - Gram24470-947218762d7-9aca-4f55-8d31-5a0756b15db112025-12-16

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 ACIDCintex Services, LLC41369b38-7f15-b597-e063-6394a90a614b2025-10-15Warnings, Adverse reactionsExact identifier
ndc (product): 24470-947

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1986360salicylic acid 28 % Topical SolutionPSN41369b38-7f15-b597-e063-6394a90a614b1
1986365XALIX 28 % Topical SolutionPSN41369b38-7f15-b597-e063-6394a90a614b1
1986365salicylic acid 280 MG/ML Topical Solution [Xalix]SBD41369b38-7f15-b597-e063-6394a90a614b1
1986360salicylic acid 280 MG/ML Topical SolutionSCD41369b38-7f15-b597-e063-6394a90a614b1
1986360salicylic acid 28 % Topical SolutionSY41369b38-7f15-b597-e063-6394a90a614b1
1986365Xalix 280 MG/ML Topical SolutionSY41369b38-7f15-b597-e063-6394a90a614b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24470-947-10244700947101 BOTTLE, WITH APPLICATOR in 1 CARTON (24470-947-10) / 10 g in 1 BOTTLE, WITH APPLICATOR2025-10-20NoNoCurrent