FDA.reportPublic FDA data

Gas-X

Product NDC
0067-0119
11-digit product format
000670119
Labeler code
0067
Product ID
0067-0119_155b17da-8661-a6be-e063-6394a90abece
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate, Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-03
Substance
CALCIUM CARBONATE; DIMETHICONE
Active strength
750; 250 mg/1; 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
Total Relief Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE750 mg/1
DIMETHICONE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H0G9379FGKInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1741562Internal RxNorm lookup
2590817Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
62fc0a91-c44f-4546-a472-c183a2d95486Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0119-01Gas-XTotal Relief Maximum Strength2 in 1 POUCHTABLET, CHEWABLE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-0119GAS-X TOTAL RELIEF MAXIMUM STRENGTH (CALCIUM CARBONATE, SIMETHICONE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]2Current NDC, Legacy NDC, 1 package rows20240406_62fc0a91-c44f-4546-a472-c183a2d95486.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 26 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC59c16c09-c23d-4a37-8460-d6c00a268ed52024-12-26WarningsExact identifier
application number: M001
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.face4e8c-3d0f-4c2e-83c1-44397b225ae72024-12-26WarningsExact identifier
application number: M001
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.3203dfc5-2cb1-4703-8d81-63fba07ddd982024-12-26WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDERichmond Pharmaceuticals, Inc.9119b7f0-3e8a-7be7-e053-2995a90a46342024-12-26WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDERichmond Pharmaceuticals, Inc.db5941b2-0a04-452a-8fbc-bd5e40fadfb12024-12-26WarningsExact identifier
application number: M001
HEB Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATEH E B2faac316-7b59-4df8-b751-37069e8652632024-12-26WarningsExact identifier
application number: M001
Good Neighbor Pharmacy Antacid Extra StrengthCALCIUM CARBONATEAmerisourceBergen Drug Corporation5e3a3c20-dabe-4427-9e75-99759905caa02024-12-26WarningsExact identifier
application number: M001
Maximum Strength Antacid Cherry liquidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC31d2e77d-5eda-4f47-917c-3390d6c782af2024-12-26WarningsExact identifier
application number: M001
Maximum Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC50ceff1e-b6df-40f8-89f3-667cc8f9e7502024-12-26WarningsExact identifier
application number: M001
HEB Extra Strength Smooth Antacid PeppermintCALCIUM CARBONATEH E Bd04e691e-6d1c-4c39-9504-7ac0f1bd197d2024-12-26WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEH E Bf294cf44-fb21-4b2e-8b7c-efd41416c6b22024-12-26WarningsExact identifier
application number: M001
AntacidCALCIUM CARBONATETrifecta Pharmaceuticals USA LLC14a7916e-5363-7f1b-e063-6294a90a20aa2024-12-20WarningsExact identifier
application number: M001
maximum strength antacid cherryALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEUNITED NATURAL FOODS, INC. DBA UNFId6b49f0a-cf05-4b1b-8cad-c5795aa316452024-12-20WarningsExact identifier
application number: M001
GOODSENSE Ultra Strength Antacid PeppermintCALCIUM CARBONATEGoodSense04950b56-7760-4b6c-8110-86b6a3f795b42024-12-19WarningsExact identifier
application number: M001
Goodsense Regular Strength Antacid PeppermintCALCIUM CARBONATEGoodSense32c04f3e-59f3-44aa-ad92-6724449827102024-12-19WarningsExact identifier
application number: M001
GOODSENSE Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEGoodSensead4d51f6-b55b-45db-b034-fb3da54fbe992024-12-19WarningsExact identifier
application number: M001
TUMS Extra Strength Sugar-FreeCALCIUM CARBONATEHaleon US Holdings LLC3495102f-55d2-4a94-8d55-f46f49e00c272024-12-19WarningsExact identifier
application number: M001
Goodsense Extra Strength Antacid Assorted FruitCALCIUM CARBONATEGoodSenseae6270fc-0f8d-4bba-8f12-adba3f07f7c52024-12-19WarningsExact identifier
application number: M001
Quality Choice Extra Strength Assorted Berry Antacid Extra strength Assorted Berry AntacidCALCIUM CARBONATEChain Drug Marketing Association Inc.ec729051-72d3-4d1a-8e39-d4495d5c1cf32024-12-18WarningsExact identifier
application number: M001
Guardian Extra Strength AntacidCALCIUM CARBONATEGuardian Drug Companyaef3d830-c5c3-4f72-86ba-d31945a756db2024-12-18WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741562calcium carbonate 750 MG / simethicone 250 MG Chewable TabletPSN62fc0a91-c44f-4546-a472-c183a2d954862
2590817Gas-X Total Relief 750 MG / 250 MG Chewable TabletPSN62fc0a91-c44f-4546-a472-c183a2d954862
2590817calcium carbonate 750 MG / simethicone 250 MG Chewable Tablet [Gas-X Total Relief]SBD62fc0a91-c44f-4546-a472-c183a2d954862
1741562calcium carbonate 750 MG / simethicone 250 MG Chewable TabletSCD62fc0a91-c44f-4546-a472-c183a2d954862
2590817Gas-X Total Relief (calcium carbonate 750 MG / simethicone 250 MG) Chewable TabletSY62fc0a91-c44f-4546-a472-c183a2d954862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0067-0119-01000670119012 TABLET, CHEWABLE in 1 POUCH (0067-0119-01) 2022-02-030000-00-00NoNoCurrent