FDA.reportPublic FDA data

Atrix System 1

Product NDC
59088-713
Requested package NDC
59088-713-00
11-digit product format
590880713
Labeler code
59088
Product ID
59088-713_292fef30-619f-a076-e063-6394a90ac4b0
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-10-25
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Atrix System 1
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
317152Internal RxNorm lookup
562600Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8d50ce6-5580-d3ef-e053-2a95a90a01d2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-445-08Atrix System 1118 mL in 1 BOTTLELIQUID118 mL20 mg in 1mL4
59088-446-05Atrix System 159 mL in 1 TUBECREAM59 mL20 mg in 1mL4
59088-713-00Atrix System 11 in 1 KITKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-713-00ML - Milliliter59088-7132842918a-0d5a-44de-b4e2-da194c13271d12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-713ATRIX SYSTEM 1 (SALICYLIC ACID) KIT [PURETEK CORPORATION]4Current NDC, Legacy NDC, 3 package rows20241215_c8d50ce6-5580-d3ef-e053-2a95a90a01d2.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
Atrix System 1SALICYLIC ACIDPureTek Corporationc8d50ce6-5580-d3ef-e053-2a95a90a01d22024-12-13WarningsExact identifier
ndc (package): 59088-713-00
ndc (product): 59088-713
ndc11 (package): 59088071300

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSNc8d50ce6-5580-d3ef-e053-2a95a90a01d24
317152salicylic acid 2 % Topical CreamPSNc8d50ce6-5580-d3ef-e053-2a95a90a01d24
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCDc8d50ce6-5580-d3ef-e053-2a95a90a01d24
317152salicylic acid 20 MG/ML Topical CreamSCDc8d50ce6-5580-d3ef-e053-2a95a90a01d24
562600salicylic acid 2 % Facial Cleanser TonerSYc8d50ce6-5580-d3ef-e053-2a95a90a01d24
562600salicylic acid 2 % Facial ScrubSYc8d50ce6-5580-d3ef-e053-2a95a90a01d24
562600salicylic acid 2 % Medicated Liquid SoapSYc8d50ce6-5580-d3ef-e053-2a95a90a01d24
317152salicylic acid 2 % Topical CreamSYc8d50ce6-5580-d3ef-e053-2a95a90a01d24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-713-00590880713001 KIT in 1 KIT (59088-713-00) * 59 mL in 1 TUBE (59088-446-05) * 118 mL in 1 BOTTLE (59088-445-08) 1 kit2021-10-250000-00-00NoNoCurrent