Home NDC 36800-488 TopCare Extra Strength Gas Relief
Product NDC 36800-488
11-digit product format 368000488
Labeler code 36800
Product ID 36800-488_433a62cb-23ea-bbb3-e063-6294a90ac883
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler TOPCO ASSOCIATES LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-07
Substance DIMETHICONE, UNSPECIFIED
Active strength 125 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 TopCare Extra Strength Gas Relief
Brand name suffix Cherry Creme
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 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 36800-488-48 TopCare Extra Strength Gas ReliefCherry Creme 48 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 48 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-488 TOPCARE EXTRA STRENGTH GAS RELIEF CHERRY CREME (SIMETHICONE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241107_4d1701fd-b797-4e95-9004-84d528941e72.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 1 of 13 · 255 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 36800-488-48 36800048848 48 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (36800-488-48) 2019-03-07 0000-00-00 No No Current