Home NDC 63187-516-00 PlusPHARMA
Product NDC 63187-516
Requested package NDC 63187-516-00
11-digit product format 631870516
Labeler code 63187
Product ID 63187-516_cf994666-c728-4a3b-a73e-f3709cbb141b
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Proficient Rx LP
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2006-03-27
Marketing end 0000-00-00
Substance DIMETHICONE
Active strength 80 mg/1
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 · 10 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…
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 PLUSPHARMA (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 1 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O PLUSPHARMA (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 1 FRUCTOSE INACTIVE INGREDIENT 6YSS42VSEV PLUSPHARMA (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D PLUSPHARMA (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PLUSPHARMA (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R PLUSPHARMA (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PLUSPHARMA (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PLUSPHARMA (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63187-516-00 63187051600 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (63187-516-00) 2018-12-01 0000-00-00 No No Current