Home NDC 53329-161-96 Remedy Skin Repair
Product NDC 53329-161
Requested package NDC 53329-161-96
11-digit product format 533290161
Labeler code 53329
Product ID 53329-161_ebe22ef9-7535-5e78-e053-2a95a90a0d3b
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 2008-08-01
Marketing end 2024-05-11
Substance DIMETHICONE
Active strength 2 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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.] 2 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 ACETYLCYSTEINE INACTIVE INGREDIENT WYQ7N0BPYC REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 ASCORBYL PALMITATE INACTIVE INGREDIENT QN83US2B0N REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 CANOLA OIL INACTIVE INGREDIENT 331KBJ17RK REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 CHOLECALCIFEROL INACTIVE INGREDIENT 1C6V77QF41 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 CORN OIL INACTIVE INGREDIENT 8470G57WFM REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 DIMETHYL SULFONE INACTIVE INGREDIENT 9H4PO4Z4FT REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 GLYCINE INACTIVE INGREDIENT TE7660XO1C REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 MANDARIN OIL INACTIVE INGREDIENT NJO720F72R REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 NIACINAMIDE INACTIVE INGREDIENT 25X51I8RD4 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 ORANGE OIL INACTIVE INGREDIENT AKN3KSD11B REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 PROLINE INACTIVE INGREDIENT 9DLQ4CIU6V REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 PYRIDOXINE HYDROCHLORIDE INACTIVE INGREDIENT 68Y4CF58BV REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 TAURINE INACTIVE INGREDIENT 1EQV5MLY3D REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 VANILLIN INACTIVE INGREDIENT CHI530446X REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 VITAMIN A PALMITATE INACTIVE INGREDIENT 1D1K0N0VVC REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R REMEDY SKIN REPAIR (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-161-96 53329016196 144 PACKET in 1 CARTON (53329-161-96) > 4 mL in 1 PACKET 144 packet 2008-08-01 2024-05-11 No No Current