Home NDC 68163-700 EXTRA STRENGTH
Product NDC 68163-700
11-digit product format 681630700
Labeler code 68163
Product ID 68163-700_fb7701f0-9b17-47b7-b21d-2b37ba7761bc
Type HUMAN OTC DRUG
Nonproprietary name SIMETHICONE
Dosage form LIQUID
Route ORAL
Labeler Raritan Pharmaceuticals Inc
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-08-26
Substance DIMETHICONE, UNSPECIFIED
Active strength 125 mg/5mL
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 EXTRA STRENGTH
Brand name suffix gas relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 125 mg/5mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68163-700-08 EXTRA STRENGTHgas relief 237 mL in 1 BOTTLE LIQUID 237 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68163-700 EXTRA STRENGTH GAS RELIEF (SIMETHICONE) LIQUID [RARITAN PHARMACEUTICALS INC] 6 Current NDC, Legacy NDC, 1 package rows 20241010_9af45664-adf4-49ce-987d-9314e9804a29.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 11 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 Marketing end Sample Exclude flag Status 68163-700-08 68163070008 237 mL in 1 BOTTLE (68163-700-08) 237 ml 2020-08-26 0000-00-00 No No Current