Home NDC 49348-188 GAS RELIEF
Product NDC 49348-188
11-digit product format 493480188
Labeler code 49348
Product ID 49348-188_ee135935-3cc2-0ef9-e053-2a95a90a7a13
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler STRATEGIC SOURCING SERVICES LLC
Application part332
Marketing category OTC MONOGRAPH FINAL
Marketing start 2016-04-01
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 · 12 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 49348-188-10 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 49348-188-10 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 49348-188-10 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 49348-188-10 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 49348-188-10 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 49348-188-10 cdf11ea48f46…ba0047e9e063…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49348-188-10 49348018810 1 BOTTLE in 1 CARTON (49348-188-10) > 100 TABLET, CHEWABLE in 1 BOTTLE 1 bottle 2016-04-01 0000-00-00 No No Current