Home NDC 51316-597 Gas Relief
Product NDC 51316-597
11-digit product format 513160597
Labeler code 51316
Product ID 51316-597_37e6d1e0-23cb-4f69-acdf-bfa8b157d16c
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler CVS PHARMACY, INC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-30
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
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 198852 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 51316-597-12 Gas Relief 120 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 120 9 51316-597-12 Gas Relief 1 in 1 BOX CAPSULE, LIQUID FILLED 1 9 51316-597-20 Gas Relief 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 9 51316-597-20 Gas Relief 72 in 1 CARTON CAPSULE, LIQUID FILLED 72 9 51316-597-30 Gas Relief 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 9 51316-597-30 Gas Relief 30 in 1 CARTON CAPSULE, LIQUID FILLED 30 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-597 GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC] 4 Current NDC, 6 package rows 20231223_4ff77b4c-9616-4341-9bf8-eca301345a5f.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 12 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 Sample Exclude flag Status 51316-597-12 51316059712 1 BOTTLE, PLASTIC in 1 BOX (51316-597-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2023-11-30 No No Current 51316-597-20 51316059720 72 BLISTER PACK in 1 CARTON (51316-597-20) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 72 blister pack 2023-11-30 No No Current 51316-597-30 51316059730 30 BLISTER PACK in 1 CARTON (51316-597-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 30 blister pack 2023-11-30 No No Current