Home NDC 80136-859 Gas Relief
Product NDC 80136-859
11-digit product format 801360859
Labeler code 80136
Product ID 80136-859_5011eca2-d61b-4e0a-a265-657c42a0853c
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Heartland Pharma Co.
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-30
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 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 Gas Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 125 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80136-859-68 Gas Relief 100 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80136-859 GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [NORTHEAST PHARMA] 3 Current NDC, 1 package rows 20240709_0860114c-53ec-48bd-a2f2-0b0bf8d2db6e.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 Sample Exclude flag Status 80136-859-68 80136085968 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (80136-859-68) 2023-06-30 No No Current