Home NDC 55910-790-01 Infants Gas Relief Drops
Product NDC 55910-790
Requested package NDC 55910-790-01
11-digit product format 559100790
Labeler code 55910
Product ID 55910-790_313ca52d-8692-43e8-beb2-7b4202f8022e
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form EMULSION
Route ORAL
Labeler DOLGENCORP INC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-01-14
Substance DIMETHICONE, UNSPECIFIED
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, UNSPECIFIED 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 55910-790-01 Infants Gas Relief Drops 1 in 1 CARTON EMULSION 1 8 55910-790-01 Infants Gas Relief Drops 30 mL in 1 BOTTLE EMULSION 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-790 INFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [DOLGENCORP INC] 7 Current NDC, Legacy NDC, 2 package rows 20240823_6b132ac0-e8eb-4199-85ad-5976558ee9c8.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 Units Marketing start Marketing end Sample Exclude flag Status 55910-790-01 55910079001 1 BOTTLE in 1 CARTON (55910-790-01) / 30 mL in 1 BOTTLE 1 bottle 2020-01-14 0000-00-00 No No Current