FDA.reportPublic FDA data

CVS Health Ultra Strength Gas Relief

Product NDC
69842-677
Requested package NDC
69842-677-50
11-digit product format
698420677
Labeler code
69842
Product ID
69842-677_edc546fd-187e-1793-e053-2995a90a143a
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-06-05
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
180 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69842-67769842-677-50IInactivated by FDA2026-10-16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-677-50CVS Health Ultra Strength Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED17
69842-677-50CVS Health Ultra Strength Gas Relief50 in 1 BOTTLECAPSULE, LIQUID FILLED507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-677CVS HEALTH ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [CVS PHARMACY]7Legacy NDC, 2 package rows20250101_1f8e9855-da9c-4135-a5b4-36f20bc5b1dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSN1f8e9855-da9c-4135-a5b4-36f20bc5b1dc7
252294simethicone 180 MG Oral CapsuleSCD1f8e9855-da9c-4135-a5b4-36f20bc5b1dc7
252294dimethicone 180 MG Oral CapsuleSY1f8e9855-da9c-4135-a5b4-36f20bc5b1dc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-677-50698420677501 BOTTLE in 1 CARTON (69842-677-50) > 50 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-06-050000-00-00NoNoCurrent