Childrens Emetrol Multi Symptom Upset Stomach Relief

Product NDC
65197-230
11-digit product format
651970230
Labeler code
65197
Product ID
65197-230_6d23c84c-4ccc-4863-8d70-e03300ccb4dd
Type
HUMAN OTC DRUG
Nonproprietary name
Childrens Emetrol Multi-Symptom Upset Stomach Relief
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-15
Substance
CALCIUM CATION; DIMETHICONE
Active strength
400; 40 mg/1; mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Childrens Emetrol Multi Symptom Upset Stomach Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CATION400 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
2M83C4R6ZBInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe9ccc29-3cca-4666-9bb5-abb41816b3f5Available on FDA.report

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
ndc (product): 65197-230
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-230-24651970230241 BOTTLE in 1 BOX (65197-230-24) / 24 TABLET, CHEWABLE in 1 BOTTLE1 bottle2026-06-15NoNoCurrent