Ala-Septic

Product NDC
59434-001
11-digit product format
594340001
Labeler code
59434
Product ID
59434-001_503ef007-a5ac-4abc-90b1-b13bd0a05d08
Type
HUMAN OTC DRUG
Nonproprietary name
Salicyclic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
Ala-Septic Pharmaceutical Research LLC
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-01
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59434-001IInactivated by FDA2026-10-15
excluded packagepackage59434-00159434-001-04IInactivated by FDA2026-10-15

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59434-001-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59434-001-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59434-001-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59434-001-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59434-001-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59434-001-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59434-001-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59434-001-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59434-001-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59434-001-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59434-001-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59434-001-04557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59434-001-048af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59434-001-04834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59434-001-041332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59434-001-04fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59434-001-0486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59434-001-04bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59434-001-048dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59434-001-04e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59434-001-049bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59434-001-04110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59434-001-042019-11-27C16284748780-19855e2a2-3f21-60a7-e053-dbdaa90a05bdAla-Septic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59434-001-04Ala-Septic100 g in 1 PACKAGECREAM1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
ALOE VERA WHOLEINACTIVE INGREDIENTKIZ4X2EHYXALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70ALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
IODOQUINOLINACTIVE INGREDIENT63W7IE88K8ALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
LARREA TRIDENTATA WHOLEINACTIVE INGREDIENTB755J144H1ALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201ALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
LICORICEINACTIVE INGREDIENT61ZBX54883ALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
POLYACRYLAMIDE (10000 MW)INACTIVE INGREDIENTE2KR9C9V2IALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1
waterINACTIVE INGREDIENT059QF0KO0RALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59434-001ALA-SEPTIC (SALICYCLIC ACID) CREAM [ALA-SEPTIC PHARMACEUTICAL RESEARCH LLC]1Legacy NDC, 1 package rows20131216_edb70750-bea8-4c0f-9453-f2c38d2f05d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317152salicylic acid 2 % Topical CreamPSNedb70750-bea8-4c0f-9453-f2c38d2f05d91
317152salicylic acid 20 MG/ML Topical CreamSCDedb70750-bea8-4c0f-9453-f2c38d2f05d91
317152salicylic acid 2 % Topical CreamSYedb70750-bea8-4c0f-9453-f2c38d2f05d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59434-001-0459434000104100 g in 1 PACKAGE100 gHistorical