SKIN CARE

Product NDC
59450-315
11-digit product format
594500315
Labeler code
59450
Product ID
59450-315_764b7c7d-32ed-4115-8aae-589869dea072
Type
HUMAN OTC DRUG
Nonproprietary name
DIMETHICONE
Dosage form
LOTION
Route
TOPICAL
Labeler
THE KROGER CO
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-06-25
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
1 mL/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct59450-315IInactivated by FDA2026-10-16
excluded packagepackage59450-31559450-315-24IInactivated by FDA2026-10-16

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59450-315-24IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59450-315-24IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59450-315-24IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59450-315-24IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59450-315-24IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59450-315-24IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59450-315-24IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59450-315-24IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59450-315-24IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59450-315-24IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59450-315-24IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59450-315-24IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59450-315-24IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59450-315-24IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59450-315-24IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59450-315-24IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59450-315-24IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59450-315-24IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59450-315-24IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59450-315-24IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59450-315-24IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59450-315-24EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59450-315-242020-01-31C16284748780-19d75b9d0-7c9c-f424-e053-dadaa90a57ceBACK LABEL - DRUG FACTS BOX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59450-315-24SKIN CARE EXTRA STRENGTH709 mL in 1 BOTTLE, PUMPLOTION7091

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208SKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
CORN OILINACTIVE INGREDIENT8470G57WFMSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
ETHYLENE BRASSYLATEINACTIVE INGREDIENT9A87HC7RODSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0ESKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62SKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
POTASSIUM LACTATEINACTIVE INGREDIENT87V1KMK4QVSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
SODIUM ISOSTEAROYL LACTYLATEINACTIVE INGREDIENT8730J0D3EVSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2SKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
SOY STEROLINACTIVE INGREDIENTPL360EPO9JSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
STEARAMIDOETHYL DIETHYLAMINEINACTIVE INGREDIENT25FFJ4209ZSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YISKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
UREAINACTIVE INGREDIENT8W8T17847WSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1
WATERINACTIVE INGREDIENT059QF0KO0RSKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-315SKIN CARE (DIMETHICONE) LOTION [THE KROGER CO]1Legacy NDC, 1 package rows20101012_82479ff0-6569-4c7a-b0a9-5b4b640eaa7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199680dimethicone 1 % Topical LotionPSN82479ff0-6569-4c7a-b0a9-5b4b640eaa7d1
199680dimethicone 10 MG/ML Topical LotionSCD82479ff0-6569-4c7a-b0a9-5b4b640eaa7d1
199680dimethicone 1 % Topical LotionSY82479ff0-6569-4c7a-b0a9-5b4b640eaa7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59450-315-2459450031524709 mL in 1 BOTTLE, PUMP709 mlHistorical