Dark Spot Corrector

Product NDC
51830-023
11-digit product format
518300023
Labeler code
51830
Product ID
51830-023_c3da5b4a-4ab9-42ac-844f-9f1fbc0ba607
Type
HUMAN OTC DRUG
Nonproprietary name
POLYETHYLENE GLYCOL 400
Dosage form
CREAM
Route
TOPICAL
Labeler
LANGE SAS
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-09-17
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 400
Active strength
0 mg/15mg
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 productproduct51830-023IInactivated by FDA2026-08-07
excluded packagepackage51830-02351830-023-03IInactivated by FDA2026-08-07

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 packagepackage51830-023-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51830-023-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51830-023-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51830-023-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51830-023-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51830-023-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51830-023-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51830-023-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51830-023-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51830-023-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51830-023-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51830-023-03557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51830-023-038af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51830-023-03834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51830-023-031332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51830-023-03fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51830-023-0386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51830-023-03bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51830-023-038dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51830-023-03e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51830-023-039bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51830-023-03110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51830-023-032019-11-27C16284748780-19855d018-dd21-cd31-e053-dbdaa90ab51a85b08f4a-d25a-4786-b700-54dca45095ad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51830-023-03Dark Spot Corrector15 mg in 1 TUBECREAM152

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
AMMONIUM ACRYLOYLDIMETHYLTAURATEINACTIVE INGREDIENTKBC00G95HIDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
ASCOPHYLLUM NODOSUMINACTIVE INGREDIENT168S4EO8YJDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
BAMBUSA VULGARIS LEAFINACTIVE INGREDIENTEMY54R518CDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RADARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1XDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
FERULIC ACIDINACTIVE INGREDIENTAVM951ZWSTDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
FREESIA ALBA FLOWERINACTIVE INGREDIENT33X293N6JTDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
GARDENIA TAITENSIS FLOWERINACTIVE INGREDIENTT0OCU8201YDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
HIBISCUS SABDARIFFA FLOWERINACTIVE INGREDIENT45TGG6IU6MDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
ICODEXTRININACTIVE INGREDIENT2NX48Z0A9GDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
LILIUM CANDIDUM FLOWERINACTIVE INGREDIENTCOV655U2CJDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M5DARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ADARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHKDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9NDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
SODIUM GLUCONATEINACTIVE INGREDIENTR6Q3791S76DARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2DARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
SULISOBENZONEINACTIVE INGREDIENT1W6L629B4KDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
TANGERINEINACTIVE INGREDIENTKH3E3096OODARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
WALTHERIA INDICA LEAFINACTIVE INGREDIENTT69OLD6617DARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2
WATERINACTIVE INGREDIENT059QF0KO0RDARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51830-023DARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2Legacy NDC, 1 package rows20130213_85b08f4a-d25a-4786-b700-54dca45095ad.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51830-023-035183000230315 mg in 1 TUBE15 mgHistorical