FDA.reportPublic FDA data

Childrens Mylicon Tummy Relief for Kids

Product NDC
62372-400
11-digit product format
623720400
Labeler code
62372
Product ID
62372-400_0b79a8a8-a1ba-7326-e063-6294a90add63
Type
HUMAN OTC DRUG
Nonproprietary name
Antacid and Antigas
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Infirst Healthcare Inc.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-09
Substance
CALCIUM CARBONATE; DIMETHICONE
Active strength
400; 40 mg/1; mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62372-40062372-400-02DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
Childrens Mylicon Tummy Relief for Kids
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE400 mg/1
DIMETHICONE40 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
1999195Internal RxNorm lookup
1999202Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
432d5b4c-a69b-45f9-b7f0-216726a3eeadAvailable 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
62372-400-02Childrens Mylicon Tummy Relief for Kids2 in 1 POUCHTABLET, CHEWABLE24
62372-400-24Childrens Mylicon Tummy Relief for Kids24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62372-400-24EA - Each62372-400d5a6d676-0133-4d85-9de8-4d70a2e8e03f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-400CHILDRENS MYLICON TUMMY RELIEF FOR KIDS (ANTACID AND ANTIGAS) TABLET, CHEWABLE [INFIRST HEALTHCARE INC.]4Current NDC, Legacy NDC, 2 package rows20231220_432d5b4c-a69b-45f9-b7f0-216726a3eead.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 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Simethicone DropsCHILDRENS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma6e26ffbe-4c5b-4689-99bc-88b39ed40a252026-06-04WarningsExact identifier
application number: M002
Infants Simethicone DropsINFANTS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma235f458e-c275-4bc1-9c0f-e007c40406492026-06-03WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONECare One (Retail Business Services, LLC.)5e2b25a0-eddf-4d58-927f-bc72c0a92c882026-06-02WarningsExact identifier
application number: M002
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
SimethiconeSIMETHICONESoftgel Healthcare Pvt Ltd32018302-7ce5-1f15-e063-6394a90ad3782026-04-27WarningsExact 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999195calcium carbonate 400 MG / simethicone 40 MG Chewable TabletPSN432d5b4c-a69b-45f9-b7f0-216726a3eead4
1999202MYLICON Children's 400 MG/ 40 MG Chewable TabletPSN432d5b4c-a69b-45f9-b7f0-216726a3eead4
1999202calcium carbonate 400 MG / simethicone 40 MG Chewable Tablet [Mylicon Children's]SBD432d5b4c-a69b-45f9-b7f0-216726a3eead4
1999195calcium carbonate 400 MG / simethicone 40 MG Chewable TabletSCD432d5b4c-a69b-45f9-b7f0-216726a3eead4
1999202Mylicon Children's (calcium Carbonate 400 MG / simethicone 40 MG) Chewable TabletSY432d5b4c-a69b-45f9-b7f0-216726a3eead4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62372-400-02623720400022 TABLET, CHEWABLE in 1 POUCH (62372-400-02) 2019-09-240000-00-00NoNoCurrent
62372-400-246237204002424 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-400-24) 2018-02-090000-00-00NoNoCurrent