Mylanta Fall Harvest Collection

Product NDC
62372-543
11-digit product format
623720543
Labeler code
62372
Product ID
62372-543_5a60414c-e058-3716-e063-6394a90a2cc5
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate,Magnesium hydroxide and Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Infirst Healthcare Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-15
Substance
CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength
800; 270; 80 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], 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], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [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
Mylanta Fall Harvest Collection
Brand name suffix
Spiced Apple Cider
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE800 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
1788932Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5a6040ff-1779-3215-e063-6294a90aaab1Available 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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62372-543-1262372054312355 mL in 1 BOTTLE, PLASTIC (62372-543-12) 355 ml2026-08-15NoNoCurrent