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 11 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone 80 mgSIMETHICONEProficient Rx LPa5e523b3-475e-4d28-a89c-c4325c59c9392024-10-01WarningsExact identifier
application number: M002
good sense gas reliefSIMETHICONEL. Perrigo Company14caaf5a-6877-40f9-af8f-fb48de94ecfe2024-09-30WarningsExact identifier
application number: M002
Care One Gas ReliefSIMETHICONEAmerican Sales Companyf42c8c2a-4ffd-465e-bb93-05ed65ba76f02024-09-15WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEPublix Super Markets Incaafa7da9-53d7-478a-805e-e68cdf54ed2b2024-09-14WarningsExact identifier
application number: M002
basic care gas reliefSIMETHICONEAmazon.com Services LLC6cd13797-207b-41fa-8dc1-5688f6b861492024-09-14WarningsExact identifier
application number: M002
meijer EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1befc6cb-a5ad-b950-e063-6394a90a5de32024-09-12WarningsExact identifier
application number: M002
meijer ULTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1bdbea4c-52f6-f855-e063-6394a90ae4fc2024-09-06WarningsExact identifier
application number: M002
Simethicone 125 mgSIMETHICONEProficient Rx LP078ef54e-96b2-4e2f-bebc-9b9bcda1f90a2024-09-01WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAdvanced Rx LLC72de768c-c011-433b-be27-f1978d18f7d82024-08-30WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAdvanced Rx LLC57d31610-c658-49cf-9de3-01e8143aeace2024-08-30WarningsExact identifier
application number: M002
QUALITY CHOICE Maximum Strength Gas Relief SoftgelSIMETHICONEChain Drug Marketing Association, Inc.462fdb9a-d685-4772-9233-6c43db9382cc2024-08-16WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreensaa074ceb-b86e-4a07-b885-b8fa6c1e0fcf2024-06-26WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreens3e5821ec-d096-4f52-82d2-475056f45e4c2024-06-26WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreens0050b639-5fb6-4503-ae73-e319cf0370272024-06-26WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLC853f5f52-8fe1-473f-b68d-2951152221202024-05-31WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEA-S Medication Solutions708cbbf2-4923-4cbf-b71c-c8bb2ce80e632024-05-29WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEUnited Natural Foods, Inc. dba UNFIa7961933-9d74-4c18-8050-2cc13cb6725e2024-05-23WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONESafeway, Inc.8927d9eb-65b2-40f3-846c-dc9cd2884dea2024-05-14WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONETARGET CORPORATIONf6ff50f5-4195-a61f-e053-6294a90a8bdf2024-05-13WarningsExact identifier
application number: M002
simethicone gas reliefSIMETHICONEMOM Enterprises, LCC536ecfdf-7124-502a-e054-00144ff8d46c2024-04-09WarningsExact 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