Mylanta Gas Minis Assorted Fruit Flavor

Product NDC
62372-801
11-digit product format
623720801
Labeler code
62372
Product ID
62372-801_0bb22980-478b-bc8c-e063-6394a90a1fee
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Infirst Healthcare Inc.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-21
Substance
DIMETHICONE
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62372-80162372-801-03DDiscontinued by firm2026-10-12
excluded packagepackage62372-80162372-801-50DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0562372-801-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0562372-801-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2662372-801-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2662372-801-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3162372-801-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3162372-801-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2862372-801-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2862372-801-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2162372-801-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2162372-801-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1062372-801-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1062372-801-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3162372-801-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3162372-801-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2062372-801-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2062372-801-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1062372-801-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1062372-801-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0862372-801-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0862372-801-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0362372-801-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0362372-801-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0962372-801-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0962372-801-03557ba5c1ecfa…9c80585c8c6e…

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
Mylanta Gas Minis Assorted Fruit Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314221Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c6db9af2-d457-477d-baa9-470ddbba5905Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-801-03Mylanta Gas Minis Assorted Fruit Flavor3 in 1 POUCHTABLET, CHEWABLE35
62372-801-50Mylanta Gas Minis Assorted Fruit Flavor50 in 1 BOTTLE, PLASTICTABLET, CHEWABLE505
62372-801-60Mylanta Gas Minis Assorted Fruit Flavor60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62372-801-50EA - Each62372-801adf07469-eb7e-42ed-9a6c-792bc85f7b2a12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-801MYLANTA GAS MINIS ASSORTED FRUIT FLAVOR (SIMETHICONE) TABLET, CHEWABLE [INFIRST HEALTHCARE INC.]5Current NDC, Legacy NDC, 3 package rows20231220_c6db9af2-d457-477d-baa9-470ddbba5905.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 3 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas ReliefSIMETHICONECVS PHARMACY, INC4ff77b4c-9616-4341-9bf8-eca301345a5f2026-05-21WarningsExact identifier
application number: M002
Phazyme UltimateSIMETHICONEC.B. Fleet Company, Inc.c8e9f6ac-2db2-4d21-a4b1-5ca6c31056622026-05-20WarningsExact identifier
application number: M002
gas reliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI2a82a06d-7511-4fc0-b182-9c1774b2af482026-05-15WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONECVS PHARMACY, INCb114b07e-6822-465a-9e74-2a741ccb19f72026-05-14WarningsExact identifier
application number: M002
Firstcare Gas Relief Simethicone 250 mg Anti-gasSIMETHICONE 250 MGUSpharma Ltd9625a697-fadc-483b-b83a-fa2cc76002ba2026-05-12WarningsExact identifier
application number: M002
Firstcare Gas Relief Simethicone 125 mg Anti-gasSIMETHICONE 125 MGUSpharma Ltde92c9661-01f2-42be-af54-42e60efcae352026-05-12WarningsExact identifier
application number: M002
Recuren Plus Antifungal CreamMICONAZOLE NITRATE 2%REGENEREN PLUS LTD3c28a93a-dd42-65b8-e063-6294a90ae6ab2026-05-07WarningsExact identifier
application number: M002
mylanta gasSIMETHICONEInfirst Healthcarece925db4-fe1a-4069-96be-ce86cdd4e79a2026-05-01WarningsExact identifier
application number: M002
PHAZYMESIMETHICONEC.B. Fleet Company, Inc.3bb5cc1f-554b-4a4d-b9e9-665e34924b4b2026-04-29WarningsExact identifier
application number: M002
Childrens Emetrol Multi Symptom Upset Stomach ReliefCHILDRENS EMETROL MULTI-SYMPTOM UPSET STOMACH RELIEFWellSpring Pharmaceutical Corporationfe9ccc29-3cca-4666-9bb5-abb41816b3f52026-04-23WarningsExact identifier
application number: M002
Little Remedies Gas Relief DropsSIMTHICONEMedtech Products Inc.874d3f1d-1e4a-49ab-8285-4d6bf2601d5e2026-04-23WarningsExact identifier
application number: M002
good sense gas reliefSIMETHICONEPreferred Pharmaceuticals Inc.06836246-9058-42af-a8a3-5aec81f4b9cc2026-04-20WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEWalgreens52cceb6b-f2c8-49bf-b5ce-5d1c999a9b602026-04-17WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEBest Choice (Valu Merchandisers Company)ce18af91-1c60-44b1-aed2-4f54d394e27e2026-04-13WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEH E Bc153585f-0f44-40ad-8246-5d9edae8325e2026-04-02WarningsExact identifier
application number: M002
ultra strength gas reliefSIMETHICONEBIONPHARMA INC.4e6ac834-9ce3-1b54-e063-6294a90a9dff2026-04-01WarningsExact identifier
application number: M002
Extra Strength Gas Relief CherrySIMETHICONEGood Sense (Geiss, Destin & Dunn, Inc.)91f72cf2-297d-48db-8f05-f8a7050d92e82026-03-31WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEHyvee Inc44ea37b1-8cd2-936d-e063-6394a90a2be72026-03-27WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEGrocery Outlet, Inc.44672e28-3305-a8cc-e063-6394a90a5fef2026-03-23WarningsExact identifier
application number: M002
gas reliefSIMETHICONEBIONPHARMA INC.4d7a9507-6f3c-6d15-e063-6294a90a01602026-03-20WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSNc6db9af2-d457-477d-baa9-470ddbba59055
314221simethicone 125 MG Chewable TabletSCDc6db9af2-d457-477d-baa9-470ddbba59055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62372-801-03623720801033 TABLET, CHEWABLE in 1 POUCH (62372-801-03) 2019-10-040000-00-00NoNoCurrent
62372-801-506237208015050 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-801-50) 2016-03-210000-00-00NoNoCurrent
62372-801-606237208016060 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-801-60) 2016-03-210000-00-00NoNoCurrent