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 firm2026-10-05
excluded packagepackage62372-80162372-801-50DDiscontinued by firm2026-10-05

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 4 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief Extra StrengthSIMETHICONEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ea6e04dd-4f57-4a88-b269-af38732915b32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.4d658287-358f-d358-e063-6294a90a4bd32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.410d80fc-e55b-08d0-e063-6294a90aba732026-03-18WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEWalgreensafcabb34-4ef4-4938-860f-154c204fcd482026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC2c7bac92-4596-40aa-a2f2-4ebe380f1f2f2026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC51dc6493-2f9f-4148-be7d-abfef1b251122026-03-10WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONETOP CARE (Topco Associates LLC)ed8a723a-7dac-4670-8f02-f4154e0a36c92026-03-02WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corpfafb57da-0682-475e-8ff9-17f2182129ef2026-02-24WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 180 MGPioneer Life Sciences, LLCf5284b68-f167-41d4-8b2f-ae7bafae0f4c2026-02-13WarningsExact identifier
application number: M002
SFEIXE ANTIFUNGAL PENUNDECYLENIC ACIDZhejiang JOOZENA Medical Technology Co., Ltd.455ad304-86bc-0abe-e063-6294a90a5b432026-02-12WarningsExact identifier
application number: M002
Gas Relief Ultimate Strength SoftgelsSIMETHICONEAdvanced Rx LLC5d412711-efd3-4b27-bfde-6fee2f460f8b2026-02-01WarningsExact identifier
application number: M002
QUITA COLICOS Gas RELIEF DropsSIMETHICONEDLC Laboratories, Inc.d4b0fa36-5925-4a6f-b3c9-0c785503976f2026-01-07WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONESafeway, Inc.7ecfe412-6a58-4dff-a52e-2e02a03426f92026-01-05WarningsExact identifier
application number: M002
Simethicone 180 MGSIMETHICONE 180 MGFarmacias De Similares TX LLC4b2166f7-8d98-dd76-e063-6394a90a7f0f2026-01-01WarningsExact identifier
application number: M002
Target Gas Relief Chews Mixed Berry and StrawberrySIMETHICONETarget11fd2ccd-3a2b-c141-e063-6394a90ab34f2025-12-20WarningsExact identifier
application number: M002
Gas Relief Simethicone 125mg SoftgelSIMETHICONENUVICARE LLCb774c8e6-e68e-4a13-834d-7eba34c5c3e02025-12-19WarningsExact identifier
application number: M002
Gas Relief Simethicone 180mg SoftgelSIMETHICONENUVICARE LLC51484644-eb45-4282-91c6-289169bcbaf62025-12-19WarningsExact identifier
application number: M002
EXTRA STRENGTH gas reliefSIMETHICONEKRAMER LABORATORIESd45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb2025-12-19WarningsExact identifier
application number: M002
SIMETHICONE 80MGSIMETHICONECardinal Health 107, LLC5e755184-0821-4f92-8f72-84726f7aa4072025-12-18WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE CAPSULES USP, 125 MGDr. Reddy's Laboratories Inc.b3069d83-5654-8469-302a-0f76c30e39762025-12-15WarningsExact 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