Home NDC 53329-140 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 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product 53329-140 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53329-140 53329-140-23 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53329-140 53329-140-04 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-140-04 Remedy Skin Repair 118 mL in 1 TUBE CREAM 118 13 53329-140-23 Remedy Skin Repair 946 mL in 1 BOTTLE, PUMP CREAM 946 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 ACETYLCYSTEINE INACTIVE INGREDIENT WYQ7N0BPYC REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 ASCORBYL PALMITATE INACTIVE INGREDIENT QN83US2B0N REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 CANOLA OIL INACTIVE INGREDIENT 331KBJ17RK REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 CHOLECALCIFEROL INACTIVE INGREDIENT 1C6V77QF41 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 CORN OIL INACTIVE INGREDIENT 8470G57WFM REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 DIMETHYL SULFONE INACTIVE INGREDIENT 9H4PO4Z4FT REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 GLYCINE INACTIVE INGREDIENT TE7660XO1C REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 NIACINAMIDE INACTIVE INGREDIENT 25X51I8RD4 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 PROLINE INACTIVE INGREDIENT 9DLQ4CIU6V REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 PYRIDOXINE HYDROCHLORIDE INACTIVE INGREDIENT 68Y4CF58BV REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 TAURINE INACTIVE INGREDIENT 1EQV5MLY3D REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 VITAMIN A PALMITATE INACTIVE INGREDIENT 1D1K0N0VVC REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-140 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, LP] 11 Legacy NDC, 2 package rows 20231025_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 51 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Copperlife Foot DIMETHICONE 1% Tommie Copper, Inc. cb825d2c-6333-3c1f-e053-2995a90a78f3 2024-12-15 Warnings Exact identifier application number: M016 Tommie Copper Foot DIMETHICONE 1% Tommie Copper, Inc. ca3d3374-a3d4-69e5-e053-2995a90a3ece 2024-12-15 Warnings Exact identifier application number: M016 Evereden Healing Eczema Treatment COLLOIDAL OATMEAL Eden Brands, Inc. d43f0eaa-aab0-eaff-e053-2995a90ac5c8 2024-12-13 Warnings Exact identifier application number: M016 Babo Fragrance Free Diaper Cream ZINC OXIDE Babo Botanicals, Inc. adcd4fc7-c400-fc8e-e053-2a95a90a7e1f 2024-12-12 Warnings Exact identifier application number: M016 Domeboro ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE Advantice Health, LLC. 28c39200-2f7c-954b-3ce7-7349b2738812 2024-12-12 Warnings Exact identifier application number: M016 Atopis Eczema Therapy Cream COLLOIDAL OATMEAL Bionona Limited 8d4b4a14-b631-f2fa-e053-2a95a90a932f 2024-12-12 Warnings Exact identifier application number: M016 Desitin Daily Defense Zinc Oxide Diaper Rash ZINC OXIDE Kenvue Brands LLC b6e0d1a3-e469-4102-916b-d5cc8ca12e73 2024-12-11 Warnings Exact identifier application number: M016 Little Me Multipurpose Baby Balm WHITE PETROLATUM Shalom International Corp e09518f1-3691-4d85-a8e1-a5c452057066 2024-12-11 Warnings Exact identifier application number: M016 Blistex Ivarest Poison Ivy Itch ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE Blistex Inc. e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a 2024-12-11 Warnings Exact identifier application number: M016 Deep Renewal Broad Spectrum DIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATE Blistex Inc 11c0e084-dc40-4969-a176-3af4116d6f27 2024-12-10 Warnings Exact identifier application number: M016 BOA VIDA Recovery Creme DIMETHICONE Central Solutions Inc bfa07058-7a20-4b9f-bad1-4b9fb5c037e0 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Canopy DIMETHICONE Central Solutions Inc 44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf 2024-12-09 Warnings Exact identifier application number: M016 DermaCen Skin Protectant ZINC OXIDE Central Solutions Inc 990c3a65-bca5-1f0d-e053-2995a90aa7ae 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Calvida ZINC OXIDE Central Solutions Inc 48eb2031-bc80-45d5-b8b3-cc08fcab64f1 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Cleansing DIMETHICONE Central Solutions Inc 0b456b20-ab06-4adf-b5f0-1693d33979df 2024-12-09 Warnings Exact identifier application number: M016 SOOTHE Sensitive Skin Treatment ALLANTOIN, DIMETHICONE Rodan & Fields 2bd8cac4-5f40-4d04-91f2-3ea8a138033b 2024-12-09 Warnings Exact identifier application number: M016 Aveeno Eczema Therapy Rescue Relief Treatment COLLOIDAL OATMEAL Kenvue Brands LLC f67e528a-b822-3f7a-e053-2995a90ae733 2024-12-06 Warnings Exact identifier application number: M016 Humphreys Maravilla WITCH HAZEL Humphreys Pharmacal, Incorporated 7d403bf4-8a0d-4337-8e81-1149cd0ae1dc 2024-12-06 Warnings Exact identifier application number: M016 Skin Soothing Cream COLLOIDAL OATMEAL Allure Labs Inc 9b1dfb4b-ce35-46a1-bfc6-ee5b871955f3 2024-12-05 Warnings Exact identifier application number: M016 Skin Soothing Cream - Nut Free COLLOIDAL OATMEAL Allure Labs b5eb48a5-e884-3bf6-e053-2a95a90abb97 2024-12-05 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-140-04 53329014004 118 mL in 1 TUBE (53329-140-04) 118 ml 2010-03-01 0000-00-00 No No Current 53329-140-23 53329014023 946 mL in 1 BOTTLE, PUMP (53329-140-23) 946 ml 2017-02-08 0000-00-00 No No Current