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 27 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BisacodylBISACODYL SUPPOSITORIESOncor Pharmaceuticals6f0aefc9-cd5f-4bdd-89c2-b6a80558987c2025-01-24WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.2c65319f-6cf5-aa90-e063-6394a90ad6622025-01-23WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECardinal Health (Leader) 70000cde87f95-73c0-46f5-9349-37e04096048c2025-01-22WarningsExact identifier
application number: M007
Senna-TabsSENNA 8.6MGUlai Health LLC485129a0-8340-4f61-be51-5abff5032b8d2025-01-20WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILTopco Associates, LLC0609468d-ee66-49af-be40-e51965b88f6f2025-01-20WarningsExact identifier
application number: M007
Soluble FiberMETHYLCELLULOSEUnited Natural Foods, Inc. dba UNFI6decd5ef-e8e1-44ae-8465-6266cf18e81e2025-01-20WarningsExact identifier
application number: M007
PerdiemSENNOSIDES, STIMULANT LAXATIVEHaleon US Holdings LLC6b256c8f-3953-4c69-9a16-ffa0511bdbcd2025-01-16WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESEverpharm LLC0ea9f2b5-4533-4b71-b019-10ecb3c064592025-01-16WarningsExact identifier
application number: M007
Anecream 5LIDOCAINE 5%Focus Health Group1810edc3-093e-402f-bcb0-9c731da283a72025-01-15WarningsExact identifier
application number: M007
SennaSENNOSIDESReliable 1 Laboratories LLCae46a611-20f2-74c8-e053-2995a90a32ce2025-01-15WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMReliable-1 Laboratories LLCa97a1829-f62f-2014-e053-2a95a90a8cc52025-01-15WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs4d678da0-9ada-4d00-9db9-33b45c7761072025-01-15WarningsExact identifier
application number: M007
Goodsense Fiber laxative 147CALCIUM POLYCARBOPHILGoodSense17f5570b-be85-9dce-e063-6294a90abeaf2025-01-14WarningsExact identifier
application number: M007
Sunmark Mineral Oil LaxativeMINERAL OILStrategic Sourcing Servicesc54f7df2-3845-425f-b13e-3dc000123f3c2025-01-14WarningsExact identifier
application number: M007
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGUlai Health LLCc0e27b02-8ef2-4239-8f8c-790f7d978dc02025-01-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals1541ff5b-11f8-444b-a2a0-8e3086ae650a2025-01-10WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAvPAKf31a4349-7826-45c0-9388-6b938d167b7a2025-01-09WarningsExact identifier
application number: M007
Docusate sodiumDOCUSATE SODIUMAPNAR PHARMA LP05b0732b-012f-78ee-e063-6294a90a839a2025-01-09WarningsExact identifier
application number: M007
Foster and Thrive Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMMcKessone5fdfcfd-5340-4929-9f68-2696110cca8e2025-01-07WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILSHANDONG XINHUA PHARMACEUTICAL CO., LTD.ee06868b-f741-8da2-e053-2a95a90a97722025-01-02WarningsExact 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