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 4 of 13 · 242 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gas Relief Extra Strength SIMETHICONE EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) ea6e04dd-4f57-4a88-b269-af38732915b3 2026-03-19 Warnings Exact identifier application number: M002 SIMETHICONE INFANT Gas Relief Drops SIMETHICONE Atlantic Biologicals Corp. 4d658287-358f-d358-e063-6294a90a4bd3 2026-03-19 Warnings Exact identifier application number: M002 SIMETHICONE INFANT Gas Relief Drops SIMETHICONE Atlantic Biologicals Corp. 410d80fc-e55b-08d0-e063-6294a90aba73 2026-03-18 Warnings Exact identifier application number: M002 Gas Relief Extra Strength SIMETHICONE Walgreens afcabb34-4ef4-4938-860f-154c204fcd48 2026-03-10 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE 125 MG Pioneer Life Sciences, LLC 2c7bac92-4596-40aa-a2f2-4ebe380f1f2f 2026-03-10 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE 125 MG Pioneer Life Sciences, LLC 51dc6493-2f9f-4148-be7d-abfef1b25112 2026-03-10 Warnings Exact identifier application number: M002 Gas Relief Extra Strength SIMETHICONE TOP CARE (Topco Associates LLC) ed8a723a-7dac-4670-8f02-f4154e0a36c9 2026-03-02 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE Shield Pharmaceuticals Corp fafb57da-0682-475e-8ff9-17f2182129ef 2026-02-24 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE 180 MG Pioneer Life Sciences, LLC f5284b68-f167-41d4-8b2f-ae7bafae0f4c 2026-02-13 Warnings Exact identifier application number: M002 SFEIXE ANTIFUNGAL PEN UNDECYLENIC ACID Zhejiang JOOZENA Medical Technology Co., Ltd. 455ad304-86bc-0abe-e063-6294a90a5b43 2026-02-12 Warnings Exact identifier application number: M002 Gas Relief Ultimate Strength Softgels SIMETHICONE Advanced Rx LLC 5d412711-efd3-4b27-bfde-6fee2f460f8b 2026-02-01 Warnings Exact identifier application number: M002 QUITA COLICOS Gas RELIEF Drops SIMETHICONE DLC Laboratories, Inc. d4b0fa36-5925-4a6f-b3c9-0c785503976f 2026-01-07 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Safeway, Inc. 7ecfe412-6a58-4dff-a52e-2e02a03426f9 2026-01-05 Warnings Exact identifier application number: M002 Simethicone 180 MG SIMETHICONE 180 MG Farmacias De Similares TX LLC 4b2166f7-8d98-dd76-e063-6394a90a7f0f 2026-01-01 Warnings Exact identifier application number: M002 Target Gas Relief Chews Mixed Berry and Strawberry SIMETHICONE Target 11fd2ccd-3a2b-c141-e063-6394a90ab34f 2025-12-20 Warnings Exact identifier application number: M002 Gas Relief Simethicone 125mg Softgel SIMETHICONE NUVICARE LLC b774c8e6-e68e-4a13-834d-7eba34c5c3e0 2025-12-19 Warnings Exact identifier application number: M002 Gas Relief Simethicone 180mg Softgel SIMETHICONE NUVICARE LLC 51484644-eb45-4282-91c6-289169bcbaf6 2025-12-19 Warnings Exact identifier application number: M002 EXTRA STRENGTH gas relief SIMETHICONE KRAMER LABORATORIES d45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb 2025-12-19 Warnings Exact identifier application number: M002 SIMETHICONE 80MG SIMETHICONE Cardinal Health 107, LLC 5e755184-0821-4f92-8f72-84726f7aa407 2025-12-18 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE CAPSULES USP, 125 MG Dr. Reddy's Laboratories Inc. b3069d83-5654-8469-302a-0f76c30e3976 2025-12-15 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