Home NDC 71594-709 Firstcare Gas Relief Simethicone 125 mg Anti-gas
Product NDC 71594-709
11-digit product format 715940709
Labeler code 71594
Product ID 71594-709_51a2f04f-736a-b1d8-e063-6294a90a6df0
Type HUMAN OTC DRUG
Nonproprietary name Simethicone 125 mg
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler USpharma Ltd
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-12
Substance DIMETHICONE
Active strength 125 mg/1
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Firstcare Gas Relief Simethicone 125 mg Anti-gas
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 125 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 314221 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 71594-709-10 Firstcare Gas Relief Simethicone 125 mg Anti-gas 100 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 100 1
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 1 of 13 · 258 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71594-709-10 71594070910 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (71594-709-10) 2026-05-12 No No Current