FDA.reportPublic FDA data

Mylanta Coat and Cool

Product NDC
62372-796
11-digit product format
623720796
Labeler code
62372
Product ID
62372-796_0bb20520-82b8-a86d-e063-6394a90ae230
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate, Magnesium hydroxide, Simethicone
Dosage form
LIQUID
Route
ORAL
Labeler
INFIRST HEALTHCARE INC.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-28
Substance
CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength
1200; 270; 80 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Mylanta Coat and Cool
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE1200 mg/10mL
MAGNESIUM HYDROXIDE270 mg/10mL
DIMETHICONE80 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H0G9379FGKInternal UNII lookup
NBZ3QY004SInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2281844Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6571f7f-e1ea-4034-a46c-4de1d01beec3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-796-12Mylanta Coat and Cool355 mL in 1 BOTTLE, PLASTICLIQUID3553

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62372-796-12ML - Milliliter62372-7964b008be4-a344-43f0-9d71-801ca3e3e16912022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-796MYLANTA COAT AND COOL (CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [INFIRST HEALTHCARE INC.]3Current NDC, Legacy NDC, 1 package rows20240111_b6571f7f-e1ea-4034-a46c-4de1d01beec3.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 27 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tums Chewy BitesCALCIUM CARBONATENavajo Manufacturing Company Inc.297d6703-ed4e-10d3-e063-6394a90a9f3a2024-12-17WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)RUGBY LABORATORIESf21c8cf7-45cb-492b-bf4a-462024a545692024-12-17WarningsExact identifier
application number: M001
Extra Strength Antacid Tablets, Caseys 4goodCALCIUM CARBONATE 750 MGLil' Drug Store Prodsucts, Inc.026aefd6-bb80-1ffd-e063-6394a90a12622024-12-16WarningsExact identifier
application number: M001
Foster and Thrive Regular Strength AntacidCALCIUM CARBONATEStrategic Sourcing Services LLC1aeb60fb-eebe-4e54-be1c-4e01f3b7269c2024-12-13WarningsExact identifier
application number: M001
Foster and Thrive Extra Strength Antacid 127AF Extra Strength Antacid Assorted FruitCALCIUM CARBONATEStrategic Sourcing Services LLC8b2fabf7-4dc6-445a-842c-b28ae081fdc82024-12-13WarningsExact identifier
application number: M001
Foster and Thrive Regular Strength Antacid PeppermintCALCIUM CARBONATEStrategic Sourcing Services LLC49d1b6c4-432b-44d3-b073-0185dbed7a902024-12-12WarningsExact identifier
application number: M001
Mylanta Maximum Strength Classic FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.56853b20-a2aa-4b19-a428-3dde232114c62024-12-11WarningsExact identifier
application number: M001
Mylanta New Tonight Soothing Honey ChamomileCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.123f3005-a0a0-4970-94f1-f6d04741078b2024-12-11WarningsExact identifier
application number: M001
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals, Inc.fd160cfd-9ad4-81c7-e053-6394a90a33f62024-12-11WarningsExact identifier
application number: M001
Topcare Ultra Strength Antacid PeppermintCALCIUM CARBONATETopco Associates, LLCfb434059-7b6e-42e0-acfa-db9879f6a4e42024-12-11WarningsExact identifier
application number: M001
TopCare Ultra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates, LLCdd038b15-2ecb-4ee2-b356-db6d87c2f01b2024-12-11WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.74823298-d24a-4ffe-8446-1661305372b22024-12-11WarningsExact identifier
application number: M001
Extra Strength Antacid Smooth Dissolve Assorted FruitCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1b6a48a7-0703-2d3d-e063-6394a90a46412024-12-11WarningsExact identifier
application number: M001
Careone Regular Strength Calcium AntacidCALCIUM CARBONATERetail Business Services, LLC.bdd9a64d-777b-45e0-8a9a-6cdc54baf8982024-12-11WarningsExact identifier
application number: M001
Careone Regular Strength calcium AntacidCALCIUM CARBONATERetail Business Services, LLC.cb6e12cc-4b88-4046-a9fc-2dbe4bca965e2024-12-11WarningsExact identifier
application number: M001
TopCare Ultra Strength Antacid Assorted BerryCALCIUM CARBONATETopco Associates, LLCc10c56ba-51cf-47f9-80a8-aa188859608f2024-12-11WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.ce2edc57-e550-4aa9-bbfe-37933913c9eb2024-12-11WarningsExact identifier
application number: M001
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corpb8712a98-30b7-4154-a5bf-0095ef9014122024-12-09WarningsExact identifier
application number: M001
HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEGERI-CARE PHARMACEUTICALS, CORP1f1dbf41-cb87-37d4-e063-6394a90ae2942024-12-09WarningsExact identifier
application number: M001
MAXIMUM STRENGTH AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp25c93d2a-3c48-ca3a-e063-6294a90a312e2024-12-09WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2281844calcium carbonate 1200 MG / magnesium hydroxide 270 MG / simethicone 80 MG in 10 mL Oral SuspensionPSNb6571f7f-e1ea-4034-a46c-4de1d01beec33
2281844calcium carbonate 120 MG/ML / magnesium hydroxide 27 MG/ML / simethicone 8 MG/ML Oral SuspensionSCDb6571f7f-e1ea-4034-a46c-4de1d01beec33
2281844calcium carbonate 1200 MG / magnesium hydroxide 270 MG / simethicone 80 MG per 10 ML Oral SuspensionSYb6571f7f-e1ea-4034-a46c-4de1d01beec33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62372-796-1262372079612355 mL in 1 BOTTLE, PLASTIC (62372-796-12) 355 ml2019-10-280000-00-00NoNoCurrent