Remedy Skin Repair

Product NDC
53329-140
11-digit product format
533290140
Labeler code
53329
Product ID
53329-140_423b458b-80fd-2c02-e063-6294a90ace4d
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-03-01
Substance
DIMETHICONE
Active strength
1.5 g/100mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Remedy Skin Repair
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE1.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309917Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab02322c-5862-4734-810e-7fb951c8d6a5Available on FDA.report

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]11Current NDC, Legacy 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 1 of 69 · 1,369 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f52026-08-04WarningsExact identifier
application number: M016
Nail Renewal LiquidGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.581f7192-fc17-a706-e063-6394a90a3ffa2026-08-03WarningsExact identifier
application number: M016
Nail Treatment Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-08-03WarningsExact identifier
application number: M016
PROCUREZINC OXIDETWIN MED, LLCe68ae97e-668e-31c2-e053-2995a90ab4d32026-08-03WarningsExact identifier
application number: M016
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
application number: M016
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
application number: M016
456 Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.5830fd36-0613-1980-e063-6294a90adfb72026-08-03WarningsExact identifier
application number: M016
Crogooe Skin Relief CreamCOLLOIDAL OATMEALGuangdong Outeli Biotechnology Co., Ltd.57f9b3e8-25d3-2b20-e063-6394a90aaea52026-08-01WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.57c3556a-aad3-3e65-e063-6394a90ab6892026-07-29WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
application number: M016
ATTITUDE Baby Leaves Diaper cream - UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)579aa481-f8ec-b263-e063-6394a90a77542026-07-27WarningsExact identifier
application number: M016
Boo Boo Magic Diaper Rash CreamyZINC OXIDEAlboo Brands LLC5114aff8-adde-e610-e063-6294a90a77ea2026-07-27WarningsExact identifier
application number: M016
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
application number: M016
Hello Bello Diaper Rash CreamZINC OXIDETopiderm, Inc.e158ba31-e159-4624-a490-fe70baaf4a392026-07-24WarningsExact identifier
application number: M016
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
application number: M016
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact 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