Home NDC 51316-110 CVS PHARMACY
Product NDC 51316-110
11-digit product format 513160110
Labeler code 51316
Product ID 51316-110_ae481994-9f88-49b2-b56a-7bfb66f3d7a5
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler CVS
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-08-05
Substance DIMETHICONE, UNSPECIFIED
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 CVS PHARMACY
Brand name suffix Extra Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 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 314221 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 51316-110-00 CVS PHARMACYExtra Strength 100 in 1 CARTON TABLET, CHEWABLE 100 6 51316-110-18 CVS PHARMACYExtra Strength 9 in 1 BLISTER PACK TABLET, CHEWABLE 9 6 51316-110-18 CVS PHARMACYExtra Strength 2 in 1 CARTON TABLET, CHEWABLE 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-110 CVS PHARMACY EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [CVS] 5 Current NDC, Legacy NDC, 3 package rows 20240326_98db6216-897c-4cf6-a4b7-b913ae3a2496.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 · 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 51316-110-00 51316011000 100 TABLET, CHEWABLE in 1 CARTON (51316-110-00) 2023-10-23 No No Current 51316-110-18 51316011018 2 BLISTER PACK in 1 CARTON (51316-110-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2021-08-05 0000-00-00 No No Current