Home NDC 55505-225 EXTRA STRENGTH
Product NDC 55505-225
11-digit product format 555050225
Labeler code 55505
Product ID 55505-225_f182e0fd-db67-4eab-9db4-faedcff42eee
Type HUMAN OTC DRUG
Nonproprietary name SIMETHICONE
Dosage form LIQUID
Route ORAL
Labeler KRAMER LABORATORIES
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-08-26
Substance DIMETHICONE, UNSPECIFIED
Active strength 125 mg/5mL
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 EXTRA STRENGTH
Brand name suffix gas relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 125 mg/5mL
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 2262288 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 55505-225-36 EXTRA STRENGTHgas relief 237 mL in 1 BOTTLE LIQUID 237 4 55505-225-83 EXTRA STRENGTHgas relief 2 in 1 PACKAGE LIQUID 2 4 55505-225-83 EXTRA STRENGTHgas relief 237 mL in 1 BOTTLE LIQUID 237 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55505-225 EXTRA STRENGTH GAS RELIEF (SIMETHICONE) LIQUID [KRAMER LABORATORIES] 3 Current NDC, 3 package rows 20250419_d45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb.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 11 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 Sample Exclude flag Status 55505-225-36 55505022536 237 mL in 1 BOTTLE (55505-225-36) 237 ml 2023-11-03 No No Current 55505-225-83 55505022583 2 BOTTLE in 1 PACKAGE (55505-225-83) / 237 mL in 1 BOTTLE 2 bottle 2025-05-01 No No Current