Remedy Dimethicone Moisture Barrier

Product NDC
53329-151
Requested package NDC
53329-151-04
11-digit product format
533290151
Labeler code
53329
Product ID
53329-151_ebe298b2-6b31-58de-e053-2a95a90a91e5
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
Medline Industries, LP
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-08-01
Marketing end
2023-11-15
Substance
DIMETHICONE
Active strength
5 g/100mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53329-15153329-151-04DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-151-04ML - Milliliter53329-1515a619ffb-0595-4641-a73d-fb815db8d8b812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1OREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
ACETYLCYSTEINEINACTIVE INGREDIENTWYQ7N0BPYCREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1REMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41REMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
CORN OILINACTIVE INGREDIENT8470G57WFMREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4REMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4REMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
GLYCINEINACTIVE INGREDIENTTE7660XO1CREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4REMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999RREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
PROLINEINACTIVE INGREDIENT9DLQ4CIU6VREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3REMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
ROSA CANINA FRUITINACTIVE INGREDIENT3TNW8D08V3REMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
TAURINEINACTIVE INGREDIENT1EQV5MLY3DREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
VANILLININACTIVE INGREDIENTCHI530446XREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RREMEDY DIMETHICONE MOISTURE BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-151-0453329015104118 mL in 1 TUBE (53329-151-04) 118 ml2007-08-012023-11-15NoNoCurrent