Home NDC 68071-2746 SIMETHICONE
Product NDC 68071-2746
11-digit product format 680712746
Labeler code 68071
Product ID 68071-2746_2eeb54a1-cc84-0293-e063-6294a90a8f00
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-01-01
Substance DIMETHICONE
Active strength 80 mg/1
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 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 2025-02-02 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 68071-2746-3 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 68071-2746-3 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 68071-2746-3 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base SIMETHICONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314216 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-2746-3 SIMETHICONE 30 in 1 BOTTLE TABLET, CHEWABLE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2746 SIMETHICONE TABLET, CHEWABLE [NUCARE PHARMACEUTICALS,INC.] 2 Current NDC, Legacy NDC, 1 package rows 20250227_e07f6acc-1b75-d8eb-e053-2a95a90a7d9b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 8 of 10 · 198 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Topcare Stomach Relief cherry BISMUTH SUBSALICYLATE Topco Associates, LLC 154b4b8f-c4d6-414b-aac3-88475669e19d 2024-12-26 Warnings Exact identifier application number: M008 Topco Stomach Relief BISMUTH SUBSALICYLATE Topco Associates, LLC 7a5be682-f13b-41a4-bf8c-724bffab2e92 2024-12-26 Warnings Exact identifier application number: M008 HEB Stomach Relief Cherry BISMUTH SUBSALICYLATE H E B 0277d4d7-c254-4eea-8f2e-4936d015a80f 2024-12-26 Warnings Exact identifier application number: M008 Equaline Maximum Strength Stomach Relief BISMUTH SUBSALICYLATE UNITED NATURAL FOODS, INC. DBA UNFI 716a7b86-4f6e-493d-ba29-d81f6ecafbf2 2024-12-20 Warnings Exact identifier application number: M008 Equaline Stomach Relief BISMUTH SUBSALICYLATE UNITED NATURAL FOODS, INC. DBA UNFI d0607a4e-de81-4881-abc7-cf0cc72a9f92 2024-12-20 Warnings Exact identifier application number: M008 Guardian Pink Bismuth BISMUTH SUBSALICYLATE Guardian Drug Company 7e83fdf2-4007-46a8-ae9d-eab5a8ff1915 2024-12-18 Warnings Exact identifier application number: M008 Stomach Relief, Caseys 4good BISMUTH SUBSALICYLATE SUSPENSION Lil' Drug Store Products, Inc. 030bb176-08ae-6c68-e063-6394a90af527 2024-12-16 Warnings Exact identifier application number: M008 Foster and Thrive Stomach Relief BISMUTH SUBSALICYLATE Strategic Sourcing Services LLC c73c6650-a7ac-4942-ae07-0bc660a0081f 2024-12-12 Warnings Exact identifier application number: M008 Foster and Thrive Regular Strength Stomach Relief 527 BISMUTH SUBSALICYLATE 525 MG Strategic Sourcing Services LLC f204f9ab-645b-4656-93a1-90aa4c369922 2024-12-12 Warnings Exact identifier application number: M008 Foster and Thrive Stomach Relief BISMUTH SUBSALICYLATE Strategic Sourcing Services LLC d18cd615-912a-4853-bb2e-225960cfe08b 2024-12-12 Warnings Exact identifier application number: M008 Topcare Ultra Strength Stomach Relief BISMUTH SUBSALICYLATE Topco Associates, LLC 908da10c-2ed1-4917-a98b-bab63d7990d4 2024-12-09 Warnings Exact identifier application number: M008 Careone Stomach Relief BISMUTH SUBSALICYLATE Retail Business Services, LLC. 214f64c9-29e4-353d-e063-6294a90a12b4 2024-11-26 Warnings Exact identifier application number: M008 Anti-Diarrheal BISMUTH SUBSALICYLATE Lil' Drug Store Products, Inc. 079901b3-393b-44f0-85c9-2d8911f2a42a 2024-11-25 Warnings Exact identifier application number: M008 Firefly Anticavity Fluoride SODIUM FLUORIDE Ranir LLC e91ed8a1-0d45-402c-9c16-1ae72e695a37 2024-11-20 Warnings Exact identifier application number: M008 Rapidol Stomach Relief BISMUTH SUBSALICYLATE Pharmadel LLC efba1aea-f468-4f63-e053-2995a90a545b 2024-11-18 Warnings Exact identifier application number: M008 RITE AID Regular Strength Pink Bismuth BISMUTH SUBSALICYLATE RITE AID CORPORATION 48fe12a5-5ff0-4d35-8708-675de32a9ed0 2024-10-31 Warnings Exact identifier application number: M008 Rite Aid Digestive Relief BISMUTH SUBSALICYLATE RITE AID CORPORATION 816c4ec4-46d1-4e8e-ad91-a11946c48769 2024-10-30 Warnings Exact identifier application number: M008 Rite Aid Stomach Relief BISMUTH SUBSALICYLATE RITE AID CORPORATION e3d49cf7-922f-438f-bc62-487a9e4db025 2024-10-30 Warnings Exact identifier application number: M008 Rite Aid Stomach Relief Original Flavor BISMUTH SUBSALICYLATE RITE AID CORPORATION 5db6ad20-208e-4881-90fc-672762f70cca 2024-10-30 Warnings Exact identifier application number: M008 Rite Aid Regular Strngth Pink Bismuth BISMUTH SUBSALICYLATE RITE AID CORPORATION 2c4acea0-dfa2-422d-a13f-17699de747e6 2024-10-30 Warnings Exact identifier application number: M008
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 68071-2746-3 68071274603 30 TABLET, CHEWABLE in 1 BOTTLE (68071-2746-3) 2022-06-02 0000-00-00 No No Current