Home NDC 53345-003 Gas Relief Ultra Strength
Product NDC 53345-003
11-digit product format 533450003
Labeler code 53345
Product ID 53345-003_2752c444-2bca-7d23-e063-6394a90a9c67
Type HUMAN OTC DRUG
Nonproprietary name Simethicone 180 mg
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-04-15
Substance DIMETHICONE 410
Active strength 180 mg/1
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 Gas Relief Ultra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 410 180 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TYU5GP6XGE 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 53345-003-03 Gas Relief Ultra Strength 1 in 1 BOX CAPSULE, LIQUID FILLED 1 3 53345-003-03 Gas Relief Ultra Strength 25000 in 1 BAG CAPSULE, LIQUID FILLED 25000 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIMETHICONE 410 ACTIVE INGREDIENT TYU5GP6XGE GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 DIMETHICONE 410 ACTIVE MOIETY TYU5GP6XGE GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53345-003 GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 3 Current NDC, Legacy NDC, 2 package rows 20241123_2cfb8132-6de4-457d-880b-c870a38862ad.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 7 of 13 · 255 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cardinal Health Infants Gas Relief SIMETHICONE CARDINAL HEALTH e0dec270-dabb-4289-b5e0-bf37f9ddcbcd 2025-10-14 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Chain Drug Marketing Association, Inc. c04422ce-779f-416a-aebf-4ccdfeaaae87 2025-10-07 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Heartland Pharma Co. 0860114c-53ec-48bd-a2f2-0b0bf8d2db6e 2025-10-03 Warnings Exact identifier application number: M002 Gas Relief Ultra Strength SIMETHICONE Preferred Pharmaceuticals Inc. 544106bc-3c80-4d43-9df3-61a931d1751e 2025-09-22 Warnings Exact identifier application number: M002 EXTRA STRENGTH SIMETHICONE SIMETHICONE Bi-Mart c1b88a30-ffeb-431c-ab73-728cdc786de0 2025-09-01 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 Curist Gas Relief SIMETHICONE Little Pharma. Inc. 3948c0e5-4ee7-5443-e063-6294a90ad6ae 2025-07-06 Warnings Exact identifier application number: M002 Simethicone 125 mg SIMETHICONE ATLANTIC BIOLOGICALS CORP. 4ce98db3-c7a6-4627-88c5-9de302a53188 2025-06-27 Warnings Exact identifier application number: M002 GNP Regular Strength Gas Relief DIMETHICONE ATLANTIC BIOLOGICALS CORP. b31257ef-489b-4067-9cc6-8a593d983958 2025-06-24 Warnings Exact identifier application number: M002 Gas-X Ultimate Strength Softgels SIMETHICONE Haleon US Holdings LLC 24b777e5-f0b5-400d-8ca9-ae0c04b8503b 2025-05-20 Warnings Exact identifier application number: M002 EXTRA STRENGTH GAS RELIEF SIMETHICONE Geri-Care Pharmaceuticals, Corp b6223134-8a2e-d1ec-e053-2995a90a9077 2025-04-28 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE 125 MG Pioneer Life Sciences, LLC 21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb 2025-04-23 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE 125 MG NUVICARE LLC 5c6352b9-fd8a-4876-b089-e4c1d15cd264 2025-04-23 Warnings Exact identifier application number: M002 Gas Relief - Cherry Flavor SIMETHICONE TARGET CORPORATION 290fe08d-a0b9-82f7-e063-6394a90a9c75 2025-04-11 Warnings Exact identifier application number: M002 Infants SIMETHICONE ATLANTIC BIOLOGICALS CORP. 27fce442-e328-41d2-bab9-87ab21550c04 2025-04-11 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 53345-003-03 53345000303 1 BAG in 1 BOX (53345-003-03) / 25000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2013-04-15 0000-00-00 No No Current