Home NDC 53329-777 Soothe and Cool INZO Barrier
Product NDC 53329-777
11-digit product format 533290777
Labeler code 53329
Product ID 53329-777_d103ac3e-c8da-4546-e053-2995a90aa0f5
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 2009-04-01
Marketing end 0000-00-00
Substance DIMETHICONE
Active strength 5 g/100mL
NDC exclude flag No
Listing certified through 2022-12-31
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 · 39 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53329-777-96 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53329-777-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53329-777-96 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53329-777-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53329-777-96 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53329-777-04 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53329-777-96 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53329-777-04 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53329-777-96 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53329-777-04 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53329-777-96 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53329-777-04 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53329-777-96 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53329-777-04 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53329-777-96 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53329-777-04 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53329-777-96 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53329-777-04 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53329-777-96 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53329-777-04 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53329-777-96 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53329-777-04 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53329-777-96 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53329-777-04 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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 53329-777-04 Soothe and Cool INZO Barrier 118 mL in 1 TUBE CREAM 118 10 53329-777-96 Soothe and Cool INZO Barrier 144 in 1 BOX CREAM 144 10 53329-777-96 Soothe and Cool INZO Barrier 8 mL in 1 PACKET CREAM 8 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 .ALPHA.-TOCOPHEROL ACETATE, D- INACTIVE INGREDIENT A7E6112E4N SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 BENZETHONIUM CHLORIDE INACTIVE INGREDIENT PH41D05744 SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 CHLOROXYLENOL INACTIVE INGREDIENT 0F32U78V2Q SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 CHOLECALCIFEROL INACTIVE INGREDIENT 1C6V77QF41 SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 QUATERNIUM-15 INACTIVE INGREDIENT E40U03LEM0 SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 VITAMIN A PALMITATE INACTIVE INGREDIENT 1D1K0N0VVC SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4 ZINC OXIDE INACTIVE INGREDIENT SOI2LOH54Z SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-777 SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, LP] 10 Legacy NDC, 3 package rows 20211118_9e6bfd97-dcbe-4f3d-8a2e-b2b7af66fae3.zip
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 53329-777-04 53329077704 118 mL in 1 TUBE (53329-777-04) 118 ml 2009-04-01 0000-00-00 No No Current 53329-777-96 53329077796 144 PACKET in 1 BOX (53329-777-96) > 8 mL in 1 PACKET 144 packet 2009-04-01 0000-00-00 No No Current