FDA.reportPublic FDA data

Gas-X

Product NDC
0067-6283
11-digit product format
000676283
Labeler code
0067
Product ID
0067-6283_155aa0c5-6407-ee86-e063-6294a90a1c4d
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
2019-03-10
Substance
DIMETHICONE
Active strength
250 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Gas-X
Brand name suffix
Maximum Strength Softgels
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
412111Internal RxNorm lookup
2119393Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
45d1e373-0717-47df-9160-619c451666f4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-6283-01Gas-XMaximum Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED107
0067-6283-01Gas-XMaximum Strength Softgels3 in 1 CARTONCAPSULE, LIQUID FILLED37
0067-6283-02Gas-XMaximum Strength Softgels5 in 1 CARTONCAPSULE, LIQUID FILLED57
0067-6283-02Gas-XMaximum Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-6283-01EA - Each0067-628334befb20-b7d6-4a8a-8844-58ad1ceeabf012024-11-05
0067-6283-02EA - Each0067-62836b0d07bc-c6ff-4b22-a68c-45e4166246e412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-6283GAS-X MAXIMUM STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 4 package rows20240406_45d1e373-0717-47df-9160-619c451666f4.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 27 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tums Chewy BitesCALCIUM CARBONATENavajo Manufacturing Company Inc.297d6703-ed4e-10d3-e063-6394a90a9f3a2024-12-17WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)RUGBY LABORATORIESf21c8cf7-45cb-492b-bf4a-462024a545692024-12-17WarningsExact identifier
application number: M001
Extra Strength Antacid Tablets, Caseys 4goodCALCIUM CARBONATE 750 MGLil' Drug Store Prodsucts, Inc.026aefd6-bb80-1ffd-e063-6394a90a12622024-12-16WarningsExact identifier
application number: M001
Foster and Thrive Regular Strength AntacidCALCIUM CARBONATEStrategic Sourcing Services LLC1aeb60fb-eebe-4e54-be1c-4e01f3b7269c2024-12-13WarningsExact identifier
application number: M001
Foster and Thrive Extra Strength Antacid 127AF Extra Strength Antacid Assorted FruitCALCIUM CARBONATEStrategic Sourcing Services LLC8b2fabf7-4dc6-445a-842c-b28ae081fdc82024-12-13WarningsExact identifier
application number: M001
Foster and Thrive Regular Strength Antacid PeppermintCALCIUM CARBONATEStrategic Sourcing Services LLC49d1b6c4-432b-44d3-b073-0185dbed7a902024-12-12WarningsExact identifier
application number: M001
Mylanta Maximum Strength Classic FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.56853b20-a2aa-4b19-a428-3dde232114c62024-12-11WarningsExact identifier
application number: M001
Mylanta New Tonight Soothing Honey ChamomileCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.123f3005-a0a0-4970-94f1-f6d04741078b2024-12-11WarningsExact identifier
application number: M001
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals, Inc.fd160cfd-9ad4-81c7-e053-6394a90a33f62024-12-11WarningsExact identifier
application number: M001
Topcare Ultra Strength Antacid PeppermintCALCIUM CARBONATETopco Associates, LLCfb434059-7b6e-42e0-acfa-db9879f6a4e42024-12-11WarningsExact identifier
application number: M001
TopCare Ultra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates, LLCdd038b15-2ecb-4ee2-b356-db6d87c2f01b2024-12-11WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.74823298-d24a-4ffe-8446-1661305372b22024-12-11WarningsExact identifier
application number: M001
Extra Strength Antacid Smooth Dissolve Assorted FruitCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1b6a48a7-0703-2d3d-e063-6394a90a46412024-12-11WarningsExact identifier
application number: M001
Careone Regular Strength Calcium AntacidCALCIUM CARBONATERetail Business Services, LLC.bdd9a64d-777b-45e0-8a9a-6cdc54baf8982024-12-11WarningsExact identifier
application number: M001
Careone Regular Strength calcium AntacidCALCIUM CARBONATERetail Business Services, LLC.cb6e12cc-4b88-4046-a9fc-2dbe4bca965e2024-12-11WarningsExact identifier
application number: M001
TopCare Ultra Strength Antacid Assorted BerryCALCIUM CARBONATETopco Associates, LLCc10c56ba-51cf-47f9-80a8-aa188859608f2024-12-11WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.ce2edc57-e550-4aa9-bbfe-37933913c9eb2024-12-11WarningsExact identifier
application number: M001
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corpb8712a98-30b7-4154-a5bf-0095ef9014122024-12-09WarningsExact identifier
application number: M001
HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEGERI-CARE PHARMACEUTICALS, CORP1f1dbf41-cb87-37d4-e063-6394a90ae2942024-12-09WarningsExact identifier
application number: M001
MAXIMUM STRENGTH AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp25c93d2a-3c48-ca3a-e063-6294a90a312e2024-12-09WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2119393Gas-X 250 MG Oral CapsulePSN45d1e373-0717-47df-9160-619c451666f47
412111simethicone 250 MG Oral CapsulePSN45d1e373-0717-47df-9160-619c451666f47
2119393simethicone 250 MG Oral Capsule [Gas-X]SBD45d1e373-0717-47df-9160-619c451666f47
412111simethicone 250 MG Oral CapsuleSCD45d1e373-0717-47df-9160-619c451666f47
412111dimethicone 250 MG Oral CapsuleSY45d1e373-0717-47df-9160-619c451666f47
2119393Gas-X 250 MG Oral CapsuleSY45d1e373-0717-47df-9160-619c451666f47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-6283-01000676283013 BLISTER PACK in 1 CARTON (0067-6283-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2019-03-100000-00-00NoNoCurrent
0067-6283-02000676283025 BLISTER PACK in 1 CARTON (0067-6283-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK5 blister pack2021-03-310000-00-00NoNoCurrent