FDA.reportPublic FDA data

Gas-X

Product NDC
0067-6275
11-digit product format
000676275
Labeler code
0067
Product ID
0067-6275_0f32f8eb-2579-4a26-99d5-a45c50bf5bdb
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-09-12
Substance
DIMETHICONE, UNSPECIFIED
Active strength
125 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gas-X
Brand name suffix
Extra Strength Softgels
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198852, 210299

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-6275-01Gas-XExtra Strength Softgels120 in 1 CARTONCAPSULE, LIQUID FILLED12015
0067-6275-10Gas-XExtra Strength Softgels1 in 1 CARTONCAPSULE, LIQUID FILLED115
0067-6275-10Gas-XExtra Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1015
0067-6275-20Gas-XExtra Strength Softgels2 in 1 CARTONCAPSULE, LIQUID FILLED215
0067-6275-20Gas-XExtra Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1015
0067-6275-30Gas-XExtra Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1015
0067-6275-30Gas-XExtra Strength Softgels3 in 1 CARTONCAPSULE, LIQUID FILLED315
0067-6275-50Gas-XExtra Strength Softgels5 in 1 CARTONCAPSULE, LIQUID FILLED515
0067-6275-50Gas-XExtra Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1015
0067-6275-72Gas-XExtra Strength Softgels6 in 1 CARTONCAPSULE, LIQUID FILLED615
0067-6275-72Gas-XExtra Strength Softgels12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1215
0067-6275-82Gas-XExtra Strength Softgels10 in 1 CARTONCAPSULE, LIQUID FILLED1015
0067-6275-82Gas-XExtra Strength Softgels12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1215

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-6275-10EA - Each0067-6275ccc8f669-4f90-41c1-98e4-34f7aec94da312012-07-24
0067-6275-20EA - Each0067-6275220653e9-beb2-4d77-b763-d523a26130b612012-07-24
0067-6275-50EA - Each0067-627590721b79-fb28-4c10-a135-2e906776dc6c12012-07-24
0067-6275-72EA - Each0067-6275515a89ce-10b6-4704-ab16-de6cfefaca9212015-01-05
0067-6275-82EA - Each0067-6275154e27b1-14f2-470e-8039-fe814791321a12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
DIMETHICONEACTIVE MOIETY92RU3N3Y1OGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
SORBITANINACTIVE INGREDIENT6O92ICV9RUGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RGAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [NOVARTIS CONSUMER HEALTH, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-6275GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]15Current NDC, Legacy NDC, 13 package rows20250316_fa4a3b07-591b-4445-aa67-b17ba1e67d5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210299Gas-X Extra Strength 125 MG Oral CapsulePSNfa4a3b07-591b-4445-aa67-b17ba1e67d5c15
198852simethicone 125 MG Oral CapsulePSNfa4a3b07-591b-4445-aa67-b17ba1e67d5c15
210299simethicone 125 MG Oral Capsule [Gas-X]SBDfa4a3b07-591b-4445-aa67-b17ba1e67d5c15
198852simethicone 125 MG Oral CapsuleSCDfa4a3b07-591b-4445-aa67-b17ba1e67d5c15
198852dimethicone 125 MG Oral CapsuleSYfa4a3b07-591b-4445-aa67-b17ba1e67d5c15
210299Gas-X 125 MG Oral CapsuleSYfa4a3b07-591b-4445-aa67-b17ba1e67d5c15
210299Gas-X Extra Strength 125 MG Oral CapsuleSYfa4a3b07-591b-4445-aa67-b17ba1e67d5c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-6275-0100067627501120 CAPSULE, LIQUID FILLED in 1 CARTON (0067-6275-01) 2017-08-010000-00-00NoNoCurrent
0067-6275-10000676275101 BLISTER PACK in 1 CARTON (0067-6275-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2011-09-120000-00-00NoNoCurrent
0067-6275-20000676275202 BLISTER PACK in 1 CARTON (0067-6275-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2011-09-120000-00-00NoNoCurrent
0067-6275-30000676275303 BLISTER PACK in 1 CARTON (0067-6275-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2011-09-120000-00-00NoNoCurrent
0067-6275-50000676275505 BLISTER PACK in 1 CARTON (0067-6275-50) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK5 blister pack2011-09-120000-00-00NoNoCurrent
0067-6275-72000676275726 BLISTER PACK in 1 CARTON (0067-6275-72) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK6 blister pack2011-09-120000-00-00NoNoCurrent
0067-6275-820006762758210 in 1 CARTONHistorical