Home NDC 71610-649 SIMETHICONE
Product NDC 71610-649
11-digit product format 716100649
Labeler code 71610
Product ID 71610-649_2b5afc84-182d-07ef-e063-6294a90a9f3e
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application M002
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 · 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 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 71610-649 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71610-649 71610-649-04 U Excluded because listing certification expired excluded / ndc_excluded.zip 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-649-04 SIMETHICONE 4 in 1 BOTTLE TABLET, CHEWABLE 4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-649 SIMETHICONE TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20250112_5df94be7-0bc9-4be1-9982-8193e3a3c8ef.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 Marketing start Marketing end Sample Exclude flag Status 71610-649-04 71610064904 4 TABLET, CHEWABLE in 1 BOTTLE (71610-649-04) 2022-05-19 0000-00-00 No No Current