Home NDC 77333-812 SIMETHICONE 80MG
Product NDC 77333-812
11-digit product format 773330812
Labeler code 77333
Product ID 77333-812_5d28be40-5dcf-23ca-e063-6294a90ace72
Type HUMAN OTC DRUG
Nonproprietary name SIMETHICONE
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Gendose Pharmaceuticals, LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-02
Substance DIMETHICONE
Active strength 80 mg/1
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 77333-812 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 77333-812 77333-812-10 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 80MG
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 80 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 77333-812-10 SIMETHICONE 80MG 100 in 1 BOX TABLET, CHEWABLE 100 6 77333-812-25 SIMETHICONE 80MG 1 in 1 BLISTER PACK TABLET, CHEWABLE 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77333-812 SIMETHICONE 80MG (SIMETHICONE) TABLET, CHEWABLE [GENDOSE PHARMACEUTICALS, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20240504_e7f470cf-f036-afd9-e053-2995a90a9186.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 3 of 13 · 242 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gas Relief SIMETHICONE CVS PHARMACY, INC 4ff77b4c-9616-4341-9bf8-eca301345a5f 2026-05-21 Warnings Exact identifier application number: M002 Phazyme Ultimate SIMETHICONE C.B. Fleet Company, Inc. c8e9f6ac-2db2-4d21-a4b1-5ca6c3105662 2026-05-20 Warnings Exact identifier application number: M002 gas relief SIMETHICONE United Natural Foods, Inc. dba UNFI 2a82a06d-7511-4fc0-b182-9c1774b2af48 2026-05-15 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE CVS PHARMACY, INC b114b07e-6822-465a-9e74-2a741ccb19f7 2026-05-14 Warnings Exact identifier application number: M002 Firstcare Gas Relief Simethicone 250 mg Anti-gas SIMETHICONE 250 MG USpharma Ltd 9625a697-fadc-483b-b83a-fa2cc76002ba 2026-05-12 Warnings Exact identifier application number: M002 Firstcare Gas Relief Simethicone 125 mg Anti-gas SIMETHICONE 125 MG USpharma Ltd e92c9661-01f2-42be-af54-42e60efcae35 2026-05-12 Warnings Exact identifier application number: M002 Recuren Plus Antifungal Cream MICONAZOLE NITRATE 2% REGENEREN PLUS LTD 3c28a93a-dd42-65b8-e063-6294a90ae6ab 2026-05-07 Warnings Exact identifier application number: M002 mylanta gas SIMETHICONE Infirst Healthcare ce925db4-fe1a-4069-96be-ce86cdd4e79a 2026-05-01 Warnings Exact identifier application number: M002 PHAZYME SIMETHICONE C.B. Fleet Company, Inc. 3bb5cc1f-554b-4a4d-b9e9-665e34924b4b 2026-04-29 Warnings Exact identifier application number: M002 Childrens Emetrol Multi Symptom Upset Stomach Relief CHILDRENS EMETROL MULTI-SYMPTOM UPSET STOMACH RELIEF WellSpring Pharmaceutical Corporation fe9ccc29-3cca-4666-9bb5-abb41816b3f5 2026-04-23 Warnings Exact identifier application number: M002 Little Remedies Gas Relief Drops SIMTHICONE Medtech Products Inc. 874d3f1d-1e4a-49ab-8285-4d6bf2601d5e 2026-04-23 Warnings Exact identifier application number: M002 good sense gas relief SIMETHICONE Preferred Pharmaceuticals Inc. 06836246-9058-42af-a8a3-5aec81f4b9cc 2026-04-20 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Walgreens 52cceb6b-f2c8-49bf-b5ce-5d1c999a9b60 2026-04-17 Warnings Exact identifier application number: M002 Gas Relief Extra Strength SIMETHICONE Best Choice (Valu Merchandisers Company) ce18af91-1c60-44b1-aed2-4f54d394e27e 2026-04-13 Warnings Exact identifier application number: M002 Gas Relief Extra Strength SIMETHICONE H E B c153585f-0f44-40ad-8246-5d9edae8325e 2026-04-02 Warnings Exact identifier application number: M002 ultra strength gas relief SIMETHICONE BIONPHARMA INC. 4e6ac834-9ce3-1b54-e063-6294a90a9dff 2026-04-01 Warnings Exact identifier application number: M002 Extra Strength Gas Relief Cherry SIMETHICONE Good Sense (Geiss, Destin & Dunn, Inc.) 91f72cf2-297d-48db-8f05-f8a7050d92e8 2026-03-31 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE Hyvee Inc 44ea37b1-8cd2-936d-e063-6394a90a2be7 2026-03-27 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE Grocery Outlet, Inc. 44672e28-3305-a8cc-e063-6394a90a5fef 2026-03-23 Warnings Exact identifier application number: M002 gas relief SIMETHICONE BIONPHARMA INC. 4d7a9507-6f3c-6d15-e063-6294a90a0160 2026-03-20 Warnings Exact identifier application number: M002
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 77333-812-10 77333081210 100 BLISTER PACK in 1 BOX (77333-812-10) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (77333-812-25) 100 blister pack 2022-10-15 0000-00-00 No No Current 77333-812-25 77333081225 1 in 1 BLISTER PACK Historical