Home NDC 0536-3604 Simethicone
Product NDC 0536-3604
11-digit product format 005363604
Labeler code 0536
Product ID 0536-3604_de9c78ef-1c4c-492a-bc15-b03406d8f69b
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Rugby Laboratories, Inc.
Application part332
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-05-09
Marketing end 2023-09-28
Substance DIMETHICONE
Active strength 180 mg/1
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0536-3604-08 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0536-3604-08 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0536-3604-08 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0536-3604-08 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0536-3604-08 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0536-3604-08 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0536-3604-08 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0536-3604-08 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0536-3604-08 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0536-3604-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0536-3604-08 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0536-3604-08 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 SIMETHICONE CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 3 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O SIMETHICONE CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SIMETHICONE CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L SIMETHICONE CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SIMETHICONE CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R SIMETHICONE CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 3 DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O SIMETHICONE CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS, INC.] 1 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O SIMETHICONE CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SIMETHICONE CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L SIMETHICONE CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SIMETHICONE CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SIMETHICONE CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0536-3604-08 00536360408 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (0536-3604-08) 2012-05-09 2023-09-28 No No Current