Home NDC 0904-5068 Mi-Acid Gas Relief
Product NDC 0904-5068
11-digit product format 009045068
Labeler code 0904
Product ID 0904-5068_5587b413-d1a1-4f5e-a62b-3b148f6df42f
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Major Pharmaceuticals
Application part332
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-03-02
Marketing end 0000-00-00
Substance DIMETHICONE
Active strength 80 mg/1
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 · 30 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-5068-60 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0904-5068-60 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0904-5068-60 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0904-5068-60 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0904-5068-60 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0904-5068-60 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0904-5068-60 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0904-5068-60 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0904-5068-60 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 0904-5068-60 I Inactivated by FDA 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 0904-5068-60 I Inactivated by FDA 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 0904-5068-60 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0904-5068-60 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…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0904-5068-60 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…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0904-5068-60 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 1 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 MI-ACID GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0904-5068-60 00904506860 100 TABLET, CHEWABLE in 1 BOTTLE (0904-5068-60) 2011-03-02 0000-00-00 No No Current