ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION

Product NDC
53208-385
11-digit product format
532080385
Labeler code
53208
Product ID
53208-385_33a6f73b-4cc8-407a-8cf1-f07403a3284a
Type
HUMAN OTC DRUG
Nonproprietary name
ARBUTIN
Dosage form
LOTION
Route
TOPICAL
Labeler
LG Household and Healthcare, Inc.
Application
part358
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-03-29
Marketing end
0000-00-00
Substance
ARBUTIN
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 productproduct53208-385IInactivated by FDA2026-08-11
excluded packagepackage53208-38553208-385-02IInactivated by FDA2026-08-11

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 packagepackage53208-385-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53208-385-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53208-385-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53208-385-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53208-385-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53208-385-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53208-385-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53208-385-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53208-385-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53208-385-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53208-385-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53208-385-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53208-385-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53208-385-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53208-385-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53208-385-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53208-385-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53208-385-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53208-385-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53208-385-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53208-385-029bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53208-385-02110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53208-385-022019-10-21C16284748780-1956f9ecf-cac5-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-385-01ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION120 g in 1 CONTAINERLOTION1201
53208-385-02ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION1 in 1 BOXLOTION11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARBUTINACTIVE INGREDIENTC5INA23HXFISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
ARBUTINACTIVE MOIETYC5INA23HXFISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
2-ETHYLHEXANOIC ACIDINACTIVE INGREDIENT01MU2J7VVZISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
BETAINEINACTIVE INGREDIENT3SCV180C9WISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
CAPRIC ACIDINACTIVE INGREDIENT4G9EDB6V73ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-385ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]1Legacy NDC, 2 package rows20100424_7ced5492-9ef6-4c0b-b040-d5dae08e4501.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53208-385-0153208038501120 g in 1 CONTAINER120 gHistorical
53208-385-02532080385021 in 1 BOXHistorical