Home NDC 69618-059 INFANTS GAS RELIEF DROPS
Product NDC 69618-059
11-digit product format 696180059
Labeler code 69618
Product ID 69618-059_57d81e8a-6332-ae27-e063-6294a90a1cbc
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form SUSPENSION/ DROPS
Route ORAL
Labeler RELIABLE 1 LABORATORIES
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-02-01
Substance DIMETHICONE
Active strength 20 mg/.3mL
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 INFANTS GAS RELIEF DROPS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 20 mg/.3mL
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 198857 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 69618-059-51 INFANTS GAS RELIEF DROPS 1 in 1 CARTON SUSPENSION/ DROPS 1 3 69618-059-51 INFANTS GAS RELIEF DROPS 30 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69618-059 INFANTS GAS RELIEF DROPS (SIMETHICONE) SUSPENSION/ DROPS [RELIABLE 1 LABORATORIES] 3 Current NDC, Legacy NDC, 2 package rows 20231108_b479bf22-3469-7916-e053-2995a90addc8.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 5 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 69618-059-51 69618005951 1 BOTTLE, DROPPER in 1 CARTON (69618-059-51) / 30 mL in 1 BOTTLE, DROPPER 2020-02-01 0000-00-00 No No Current