Home NDC 57896-798 INFANTS GAS RELIEF
Product NDC 57896-798
11-digit product format 578960798
Labeler code 57896
Product ID 57896-798_091b57c6-f9b1-6a51-e063-6294a90a403f
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form SUSPENSION
Route ORAL
Labeler Geri-Care Pharmaceuticals, Corp
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-05-01
Substance DIMETHICONE
Active strength 20 mg/.3mL
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 INFANTS GAS RELIEF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 20 mg/.3mL
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 198857 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57896-798-01 INFANTS GAS RELIEF 30 mL in 1 BOTTLE SUSPENSION 30 4 57896-798-01 INFANTS GAS RELIEF 1 in 1 BOX SUSPENSION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57896-798 INFANTS GAS RELIEF (SIMETHICONE) SUSPENSION [GERI-CARE PHARMACEUTICALS, CORP] 4 Current NDC, Legacy NDC, 2 package rows 20231102_5e08709c-846a-7f13-e053-2991aa0a09a6.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 Marketing end Sample Exclude flag Status 57896-798-01 57896079801 1 BOTTLE in 1 BOX (57896-798-01) / 30 mL in 1 BOTTLE 1 bottle 2014-05-01 0000-00-00 No No Current