FDA.reportPublic FDA data

Pedia-Lax

Product NDC
0132-0655
11-digit product format
001320655
Labeler code
0132
Product ID
0132-0655_ba6860a3-95dd-4ab8-8c1d-95aa836443f1
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium hydroxide
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
C.B. Fleet Company, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-03-01
Substance
MAGNESIUM HYDROXIDE
Active strength
400 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
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
Pedia-Lax
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM HYDROXIDE400 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
790436Internal RxNorm lookup
1088243Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
975f24d8-218c-40f4-84a5-558acf34329dAvailable 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
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
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
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0655-01Pedia-Lax30 in 1 BOTTLETABLET, CHEWABLE307
0132-0655-01Pedia-Lax1 in 1 CARTONTABLET, CHEWABLE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0132-0655-01EA - Each0132-0655476dfcc1-887f-4cb3-9f77-ec73dcf6725d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Magnesium HydroxideACTIVE INGREDIENTNBZ3QY004SPEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4
Magnesium HydroxideACTIVE MOIETYNBZ3QY004SPEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DPEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36APEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RPEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4
WATERMELONINACTIVE INGREDIENT231473QB6RPEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0655PEDIA-LAX (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]7Current NDC, Legacy NDC, 2 package rows20240410_975f24d8-218c-40f4-84a5-558acf34329d.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 22 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna SyrupNATURAL VEGETABLE LAXATIVEMethod Pharmaceuticalsce83ba78-7e0d-b37f-e053-2995a90a93832025-10-21WarningsExact identifier
application number: M007
Fiber LaxCALCIUM POLYCARBOPHILPD-Rx Pharmaceuticals, Inc.730198a5-b6d9-4fc7-b053-a7c65a93c5402025-10-20WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Consortium LLC4694f05b-d927-4e15-9630-a0a1cddb3cbb2025-10-16WarningsExact identifier
application number: M007
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacye6a8914f-cfd9-4c72-abaa-22189bf0faef2025-10-16WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.3386fada-6b7f-46fd-e063-6294a90abffc2025-10-16WarningsExact identifier
application number: M007
Senna SyrupSENNA SYRUPKesin Pharma Corporation360fb98d-c6ad-7bcc-e063-6294a90a94532025-10-14WarningsExact identifier
application number: M007
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
application number: M007
SENNA WITH DOCUSATE SODIUMDOCUSATE SODIUM AND SENNOSIDESHHH Pharmaceuticals2bbb1b99-d43c-40a3-bc53-e18e8394c3182025-10-08WarningsExact identifier
application number: M007
Castor OilCASTOR OILBIONPHARMA INC.3f9728e8-c7a2-6cfb-e063-6394a90a8f1d2025-10-06WarningsExact identifier
application number: M007
SennosidesSENNOSIDESInvaTech Pharma Solutions LLC3de39fbd-29be-fce7-e063-6394a90a67ae2025-10-03WarningsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKThe Procter & Gamble Manufacturing Companya9824f73-5ea2-4a65-a926-3a57561441b82025-10-01WarningsExact identifier
application number: M007
OneLAX SENNASENNAAtlantic Biologicals Corp.40202c76-4273-88fd-e063-6394a90a07b22025-10-01WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONBionpharma, Inc.4019fbd0-fcf9-77a6-e063-6294a90a5ae72025-09-30WarningsExact identifier
application number: M007
LEADER HYDROCORTISONE WITH ALOEHYDROCORTISONELEADER39916470-15bf-4bd0-96e2-b909d68cf9c42025-09-29WarningsExact identifier
application number: M007
Leader Ready to Use Mineral Oil LaxativeMINERAL OILCardinal Healthb8494d02-8a7d-47b4-80b0-b8ab51b625fd2025-09-29WarningsExact identifier
application number: M007
Leader Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMCardinal Health1b4f9c28-0547-4922-aa15-990c6fd9dc9f2025-09-29WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEKesin Pharma Corporation3f7cff50-749b-5275-e063-6394a90af4072025-09-23WarningsExact identifier
application number: M007
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGBryant Ranch Prepack12f613e4-c919-4cc4-a445-eb30039ae45f2025-09-18WarningsExact identifier
application number: M007
Saline LaxativeSALINE LAXATIVEMajor Pharmaceuticalsb3758ffe-1bac-4df6-9714-5e33e9d28d902025-09-16WarningsExact identifier
application number: M007
Gentle LaxativeBISACODYLBETTER LIVING BRANDS LLC.f29d57f6-0938-d459-e053-2995a90ad86b2025-09-13WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
790436magnesium hydroxide 400 MG Chewable TabletPSN975f24d8-218c-40f4-84a5-558acf34329d7
1088243Pedia-Lax Chewable 400 MG Chewable TabletPSN975f24d8-218c-40f4-84a5-558acf34329d7
1088243magnesium hydroxide 400 MG Chewable Tablet [Pedia-Lax Chewable]SBD975f24d8-218c-40f4-84a5-558acf34329d7
790436magnesium hydroxide 400 MG Chewable TabletSCD975f24d8-218c-40f4-84a5-558acf34329d7
790436milk of magnesia 400 MG Chewable TabletSY975f24d8-218c-40f4-84a5-558acf34329d7
1088243Pedia-Lax Chewable 400 MG Chewable TabletSY975f24d8-218c-40f4-84a5-558acf34329d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0132-0655-01001320655011 BOTTLE in 1 CARTON (0132-0655-01) / 30 TABLET, CHEWABLE in 1 BOTTLE1 bottle2008-03-010000-00-00NoNoCurrent