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 6 of 13 · 242 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gas Relief SIMETHICONE Meijer Distribution, Inc. 7723821e-b2fc-4c9c-a389-05184aaea19f 2025-11-15 Warnings Exact identifier application number: M002 TopCare Extra Strength Gas Relief Cherry Creme SIMETHICONE TOPCO ASSOCIATES LLC 4d1701fd-b797-4e95-9004-84d528941e72 2025-11-10 Warnings Exact identifier application number: M002 up and up extra strength gas relief chewables Extra Strength SIMETHICONE Target Corporation 0a015c48-680c-4de1-91e7-1c1145239d8e 2025-11-04 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE SAFEWAY c8946bd2-6351-40e4-a139-d8214889bb4e 2025-10-29 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE ANTIGAS SAFEWAY cbbd43eb-1155-4e0d-bed4-32343f34b503 2025-10-29 Warnings Exact identifier application number: M002 meijer EXTRA STRENGTH Gas Relief SIMETHICONE Meijer, Inc 3e83bb0f-d909-08c3-e063-6294a90ae138 2025-10-29 Warnings Exact identifier application number: M002 PUBLIX Extra Strength SIMETHICONE PUBLIX SUPER MARKETS, INC 089d77c9-7aa0-4eee-8363-c47a2d5928cf 2025-10-28 Warnings Exact identifier application number: M002 Extra Strength gas relief SIMETHICONE PUBLIX SUPER MARKETS, INC, 029f9254-8cfd-4ea0-8691-2d87df450433 2025-10-28 Warnings Exact identifier application number: M002 Publix Infants Dye Free Gas Relief SIMETHICONE PUBLIX SUPER MARKETS, INC 2fe74800-a1f6-4774-9976-d6767ba34b49 2025-10-28 Warnings Exact identifier application number: M002 Extra Strength Gas Relief SIMETHICONE Wal-Mart Stores,Inc., e6087f04-20bf-402c-892b-e64f778b0144 2025-10-27 Warnings Exact identifier application number: M002 Infants Gas Relief Drops SIMETHICONE Wal-Mart Stores,Inc., 966f0506-c2d2-4d3c-bd2d-c5a6b1e0a157 2025-10-27 Warnings Exact identifier application number: M002 Infants SIMETHICONE RUGBY LABORATORIES c6fa71bc-de48-47f4-80c4-7d92643d2664 2025-10-25 Warnings Exact identifier application number: M002 PHAZYME SIMETHICONE C.B. Fleet Company, Inc. ea04f5a5-cf56-4176-a234-5a73e01ff218 2025-10-23 Warnings Exact identifier application number: M002 Cardinal Health Infants Gas Relief SIMETHICONE CARDINAL HEALTH e0dec270-dabb-4289-b5e0-bf37f9ddcbcd 2025-10-14 Warnings Exact identifier application number: M002 Quality Choice Infants Gas Relief Dye Free SIMETHICONE QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) 841b85ef-2ac8-4dac-8659-cffb7e1b1e05 2025-08-23 Warnings Exact identifier application number: M002 CVS Health Gas Relief SOFTGEL SIMETHICONE CVS Pharmacy, Inc 2911cac8-45ec-1294-e063-6294a90a4a74 2025-08-22 Warnings Exact identifier application number: M002 TopCare health EXTRA STRENGTH Gas Relief SOFTGEL SIMETHICONE Topco Associates LLC 2ea0eb22-f679-d136-e063-6294a90a1dfe 2025-08-01 Warnings Exact identifier application number: M002 SIMETHICONE INFANT Gas Relief Drops SIMETHICONE AARNA USA Inc. 9b0fde90-35ae-498e-99cc-d120f1a87182 2025-07-29 Warnings Exact identifier application number: M002 Gas Relief Ultra Strength SIMETHICONE Rugby Laboratories, Inc. 24731f4b-ca2b-483f-beed-dfc8104f8133 2025-07-18 Warnings Exact identifier application number: M002 Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONE American Health Packaging 23539e7e-a723-460f-892f-dac5bbbb9b16 2025-07-15 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