Gas Relief

Product NDC
36800-197
11-digit product format
368000197
Labeler code
36800
Product ID
36800-197_19ede766-ef3e-43f1-912b-a6bf2c75ddb5
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-29
Substance
DIMETHICONE
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

Additional Listing Data#

Finished product
Yes
Brand name base
Gas Relief
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198852

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-197-30Gas ReliefExtra Strength30 in 1 CARTONCAPSULE, LIQUID FILLED306
36800-197-30Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED16
36800-197-50Gas ReliefExtra Strength50 in 1 CARTONCAPSULE, LIQUID FILLED506
36800-197-50Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-197GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]4Current NDC, Legacy NDC, 4 package rows20241115_ed8a723a-7dac-4670-8f02-f4154e0a36c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSNed8a723a-7dac-4670-8f02-f4154e0a36c96
198852simethicone 125 MG Oral CapsuleSCDed8a723a-7dac-4670-8f02-f4154e0a36c96
198852dimethicone 125 MG Oral CapsuleSYed8a723a-7dac-4670-8f02-f4154e0a36c96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-197-303680001973030 BLISTER PACK in 1 CARTON (36800-197-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK30 blister pack2019-11-290000-00-00NoNoCurrent
36800-197-503680001975050 BLISTER PACK in 1 CARTON (36800-197-50) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK50 blister pack2019-11-290000-00-00NoNoCurrent