FDA.reportPublic FDA data

MiraFAST KIDS soft chews

Product NDC
11523-8296
11-digit product format
115238296
Labeler code
11523
Product ID
11523-8296_58636827-239e-cc63-e063-6294a90a6180
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium Hydroxide
Dosage form
BAR, CHEWABLE
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-17
Substance
MAGNESIUM HYDROXIDE
Active strength
1200 mg/1
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], 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
MiraFAST KIDS soft chews
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM HYDROXIDE1200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NBZ3QY004SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2280709Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58636827-239d-cc63-e063-6294a90a6180Available 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 24 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FleetBISACODYLC.B. Fleet Company, Inc.324e61eb-8f6b-48d7-85c2-b1b5642691c92025-06-23WarningsExact identifier
application number: M007
Saline LaxativeSODIUM PHOSPHATEWalgreen Companyfb260df0-7bda-4299-84a5-44c8f94477982025-06-18WarningsExact identifier
application number: M007
De La Cruz Castor OilCASTOR OILDLC Laboratories, Inc.22fbad2e-e9fa-46ba-8617-ad79483cbe9a2025-06-13WarningsExact identifier
application number: M007
ProlaxaDOCUSATE SODIUM 250MGTerrain Pharmaceuticals32610e42-f352-09fd-e063-6394a90abff62025-06-12WarningsExact identifier
application number: M007
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGVillage Pharma29102014-9b0e-4899-958d-83111f94a6122025-06-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPower Health, Products, Inc.364b558b-69b5-bfa4-e063-6294a90acd0c2025-05-29WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPower Health, Products, Inc.364bc4f5-6337-6c89-e063-6394a90a12ab2025-05-29WarningsExact identifier
application number: M007
SENNASENNOSIDESAARNA USA INC.364d4dfc-a089-1a27-e063-6394a90ad77b2025-05-29WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEPower Health, Products, Inc.3634b4e4-4fea-9428-e063-6394a90a6ad92025-05-28WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEATLANTIC BIOLOGICALS CORP.30fb7b5e-56a3-423e-ae57-432006b54fff2025-05-23WarningsExact identifier
application number: M007
Senna LiquidSENNA LIQUIDBelleview Biosciences35d5f217-b101-3cd8-e063-6394a90adccd2025-05-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreens816c82f8-0fa5-4b22-a226-e8f22f3eaa1d2025-05-23WarningsExact identifier
application number: M007
Senna LaxativeSENNAPD-Rx Pharmaceuticals, Inc.2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa2025-05-21WarningsExact identifier
application number: M007
SennaSENNOSIDESAkron Pharma Inc.55ce3969-d7a6-49c4-8c13-d95690efc1a62025-05-16WarningsExact identifier
application number: M007
Saline EnemaSODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASICDynarex Corporation7c7b68af-4ef2-4f84-9279-9f7a91c8d9c52025-05-14WarningsExact identifier
application number: M007
BisacodylBISACODYLRising Pharma Holdings, Inc.03429da4-1ce9-4789-bf54-ce1b3215b0132025-05-13WarningsExact identifier
application number: M007
COLACE EXTRA STRENGTH STOOL SOFTNERDOCUSATE SODIUMAtlantis Consumer Healthcare Inc.34e06b05-64a5-4b3e-af38-cdcd7c1d521b2025-05-01WarningsExact identifier
application number: M007
SennaSENNOSIDESPAI Holdings, LLC dba PAI Pharma7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed2025-04-28WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMBelleview Bio Science335f41d7-5c22-7c17-e063-6294a90a8f282025-04-22WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAmerican Health Packaginge5028f6d-d33d-47a9-8453-00af5cdf59a62025-04-20WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11523-8296-11152382960115 POUCH in 1 CARTON (11523-8296-1) / 1 BAR, CHEWABLE in 1 POUCH15 pouch2025-02-17NoNoCurrent