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 12 of 13 · 242 matching rows.
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