Home NDC 57896-791 SIMETHICONE
Product NDC 57896-791
11-digit product format 578960791
Labeler code 57896
Product ID 57896-791_43d043e1-1f90-dc96-e063-6294a90addfb
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Geri-Care Pharmaceuticals, Corp
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-01-01
Substance DIMETHICONE
Active strength 80 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 80 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 314216 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 57896-791-01 SIMETHICONE 100 in 1 BOTTLE TABLET, CHEWABLE 100 7 57896-791-08 SIMETHICONE 80 in 1 BOTTLE TABLET, CHEWABLE 80 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] 1 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] 1 TRICALCIUM PHOSPHATE INACTIVE INGREDIENT K4C08XP666 SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57896-791 SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] 6 Current NDC, Legacy NDC, 2 package rows 20241204_be96ce05-dd74-4915-9a8f-2a1b34e2f158.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 Marketing start Marketing end Sample Exclude flag Status 57896-791-01 57896079101 100 TABLET, CHEWABLE in 1 BOTTLE (57896-791-01) 2016-09-01 0000-00-00 No No Current 57896-791-08 57896079108 80 TABLET, CHEWABLE in 1 BOTTLE (57896-791-08) 2021-08-01 0000-00-00 No No Current