Salicylic Acid

Product NDC
42808-399
11-digit product format
428080399
Labeler code
42808
Product ID
42808-399_129ccc6e-4eb2-495d-8583-427cb223b783
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
KIT
Labeler
Exact-Rx, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-08-01
Marketing end
0000-00-00
Active strength
0
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 productproduct42808-399IInactivated by FDA2026-10-05
excluded packagepackage42808-39942808-399-16IInactivated by FDA2026-10-05

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 packagepackage42808-399-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42808-399-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42808-399-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42808-399-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42808-399-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42808-399-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42808-399-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42808-399-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42808-399-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42808-399-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42808-399-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42808-399-16557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42808-399-168af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42808-399-16834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42808-399-161332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42808-399-16fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42808-399-1686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42808-399-16bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42808-399-168dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42808-399-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42808-399-169bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42808-399-16110d247fa046…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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42808-399-162019-11-13C16284748780-197449f38-cd67-f6ea-e053-dbdaa90aa703Salicylic Acid 6% Cream Kit Salicylic Acid 6% Lotion Kit Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42808-399-16Salicylic Acid1 in 1 CARTONKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42808-399-16EA - Each42808-3993fdb0e61-85e7-4d20-be19-a457602245bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZSALICYLIC ACID KIT [EXACT-RX, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSALICYLIC ACID KIT [EXACT-RX, INC.]1
AMMONIUM LACTATEINACTIVE INGREDIENT67M901L9NQSALICYLIC ACID KIT [EXACT-RX, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ESALICYLIC ACID KIT [EXACT-RX, INC.]1
CERAMIDE 3INACTIVE INGREDIENT4370DF050BSALICYLIC ACID KIT [EXACT-RX, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSALICYLIC ACID KIT [EXACT-RX, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSALICYLIC ACID KIT [EXACT-RX, INC.]1
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JSALICYLIC ACID KIT [EXACT-RX, INC.]1
DIMETHICONE 350INACTIVE INGREDIENT2Y53S6ATLUSALICYLIC ACID KIT [EXACT-RX, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSALICYLIC ACID KIT [EXACT-RX, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSALICYLIC ACID KIT [EXACT-RX, INC.]1
GLYCERYL 1-STEARATEINACTIVE INGREDIENT258491E1RZSALICYLIC ACID KIT [EXACT-RX, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SALICYLIC ACID KIT [EXACT-RX, INC.]1
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQYSALICYLIC ACID KIT [EXACT-RX, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSALICYLIC ACID KIT [EXACT-RX, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSALICYLIC ACID KIT [EXACT-RX, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSALICYLIC ACID KIT [EXACT-RX, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSALICYLIC ACID KIT [EXACT-RX, INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ISALICYLIC ACID KIT [EXACT-RX, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHSALICYLIC ACID KIT [EXACT-RX, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MSALICYLIC ACID KIT [EXACT-RX, INC.]1
POTASSIUM PHOSPHATEINACTIVE INGREDIENTB7862WZ632SALICYLIC ACID KIT [EXACT-RX, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSALICYLIC ACID KIT [EXACT-RX, INC.]1
SODIUM LAUROYL LACTYLATEINACTIVE INGREDIENT7243K85WFOSALICYLIC ACID KIT [EXACT-RX, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSALICYLIC ACID KIT [EXACT-RX, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSALICYLIC ACID KIT [EXACT-RX, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSALICYLIC ACID KIT [EXACT-RX, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESALICYLIC ACID KIT [EXACT-RX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42808-399SALICYLIC ACID KIT [EXACT-RX, INC.]1Legacy NDC, 1 package rows20111130_129ccc6e-4eb2-495d-8583-427cb223b783.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477031salicylic acid 6 % Topical CreamPSN129ccc6e-4eb2-495d-8583-427cb223b7831
477031salicylic acid 60 MG/ML Topical CreamSCD129ccc6e-4eb2-495d-8583-427cb223b7831
477031salicylic acid 6 % Topical CreamSY129ccc6e-4eb2-495d-8583-427cb223b7831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42808-399-16428080399161 in 1 CARTONHistorical