Home NDC 53345-036 Simethicone
Product NDC 53345-036
11-digit product format 533450036
Labeler code 53345
Product ID 53345-036_27c818a0-ee73-b3e3-e063-6394a90a83e9
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-25
Substance DIMETHICONE
Active strength 180 mg/1
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 180 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 252294 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 53345-036-01 Simethicone 25000 in 1 BAG CAPSULE, LIQUID FILLED 25000 2 53345-036-01 Simethicone 1 in 1 BOX CAPSULE, LIQUID FILLED 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53345-036 SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD] 2 Current NDC, Legacy NDC, 2 package rows 20241127_346df37d-b0fc-4fa5-8c19-492fed58c239.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 53345-036-01 53345003601 1 BAG in 1 BOX (53345-036-01) / 25000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2016-07-25 0000-00-00 No No Current