Remedy Skin Repair

Product NDC
53329-140
11-digit product format
533290140
Labeler code
53329
Product ID
53329-140_efcfafc0-8daf-3693-e053-2995a90a983f
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-03-01
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
2 g/100mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53329-140DDiscontinued by firm2026-10-12
excluded packagepackage53329-14053329-140-04DDiscontinued by firm2026-10-12
excluded packagepackage53329-14053329-140-23DDiscontinued by firm2026-10-12

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproduct53329-140IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53329-14053329-140-23IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53329-14053329-140-04IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…

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
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-140-04Remedy Skin Repair118 mL in 1 TUBECREAM11813
53329-140-23Remedy Skin Repair946 mL in 1 BOTTLE, PUMPCREAM94613

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
DIMETHICONEACTIVE MOIETY92RU3N3Y1OREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
ACETYLCYSTEINEINACTIVE INGREDIENTWYQ7N0BPYCREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
CANOLA OILINACTIVE INGREDIENT331KBJ17RKREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
CORN OILINACTIVE INGREDIENT8470G57WFMREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
GLYCINEINACTIVE INGREDIENTTE7660XO1CREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
PROLINEINACTIVE INGREDIENT9DLQ4CIU6VREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
TAURINEINACTIVE INGREDIENT1EQV5MLY3DREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RREMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-140REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, LP]11Legacy NDC, 2 package rows20231025_ab02322c-5862-4734-810e-7fb951c8d6a5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
application number: M016
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
application number: M016
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELUnited Natural Foods, Inc. dba UNFId2d1bd9e-7025-4151-95f2-a2f521dc2be82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-08-27WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
application number: M016
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsExact identifier
application number: M016
Serawise Eczema ReliefOATMEALDrAnaMaria. Com LLCf0681436-d140-4e02-afe4-5b16de07afcd2026-08-26WarningsExact identifier
application number: M016
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsExact identifier
application number: M016
Growth TreatmentGLYCERINShantou Ouhoe Technology Co., Ltd.59fe12eb-574f-a199-e063-6394a90abd062026-08-26WarningsExact identifier
application number: M016
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELYour Military Exchanges4079fd56-55f3-4e69-93e0-7590c07fb7942026-08-25Warnings, Adverse reactionsExact identifier
application number: M016
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
application number: M016
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
application number: M016
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309917dimethicone 1.5 % Topical CreamPSNab02322c-5862-4734-810e-7fb951c8d6a513
309917dimethicone 15 MG/ML Topical CreamSCDab02322c-5862-4734-810e-7fb951c8d6a513
309917dimethicone 1.5 % Topical CreamSYab02322c-5862-4734-810e-7fb951c8d6a513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-140-0453329014004118 mL in 1 TUBE (53329-140-04) 118 ml2010-03-010000-00-00NoNoCurrent
53329-140-2353329014023946 mL in 1 BOTTLE, PUMP (53329-140-23) 946 ml2017-02-080000-00-00NoNoCurrent