FDA.reportPublic FDA data

Pedia-Lax

Product NDC
0132-0190
11-digit product format
001320190
Labeler code
0132
Product ID
0132-0190_530334c7-fa4f-462f-8816-5ad794056ef4
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
LIQUID
Route
RECTAL
Labeler
C.B. Fleet Company, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-03-01
Substance
GLYCERIN
Active strength
2.8 g/2.7mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0132-0190UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0132-01900132-0190-12UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
GLYCERIN2.8 g/2.7mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
895966Internal RxNorm lookup
1190433Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e15f6ca-a40c-485f-be3f-07c2ed7cb498Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0190-12Pedia-Lax4 mL in 1 APPLICATORLIQUID411
0132-0190-12Pedia-Lax6 in 1 CARTONLIQUID611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0132-0190-12ML - Milliliter0132-01900fb99c8a-0c19-47fe-843f-9116b56a419b12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GlycerinACTIVE INGREDIENTPDC6A3C0OXPEDIA-LAX (GLYCERIN) LIQUID [C.B. FLEET COMPANY, INC.]3
GlycerinACTIVE MOIETYPDC6A3C0OXPEDIA-LAX (GLYCERIN) LIQUID [C.B. FLEET COMPANY, INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPEDIA-LAX (GLYCERIN) LIQUID [C.B. FLEET COMPANY, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RPEDIA-LAX (GLYCERIN) LIQUID [C.B. FLEET COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0190PEDIA-LAX (GLYCERIN) LIQUID [C.B. FLEET COMPANY, INC.]11Current NDC, Legacy NDC, 2 package rows20250119_4e15f6ca-a40c-485f-be3f-07c2ed7cb498.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 6 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature CareCASTORBetter Living Brands, LLC4947cf4d-3ebd-4b66-9582-f141407aa3002026-06-15Warnings, Adverse reactionsExact identifier
application number: M007
WALGREEN GLYCERIN ADULTGLYCERIN SUPPOSITORYWalgreens20c44346-0b29-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
application number: M007
WALGREENS GLYCERINGLYCERIN SUSPENSIONWalgreens20c44346-0b2b-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
application number: M007
Stratuscare BisacodylBISACODYLStratus Pharmaceuticals795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d2026-06-09WarningsExact identifier
application number: M007
LaxativeLAXATIVEAllegiant Health596b11de-cf17-4c55-8638-49f387e5fac42026-06-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)16691fd4-cdf3-41d4-b851-5fa148a054682026-06-08WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDECardinal Health 107, LLC144c7242-4ff9-404a-86bf-48e2871eb0cd2026-06-05WarningsExact identifier
application number: M007
Senna Natural VegetableSENNOSIDESMedline Industries, LP9a6240f3-398c-06b8-e053-2995a90a73df2026-06-04WarningsExact identifier
application number: M007
Senna SSENNOSIDES AND DOCUSATE SODIUMMedline Industries, LP6cd22881-db60-9045-e053-2991aa0ae08a2026-06-04WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.53727f3a-914c-0e2c-e063-6394a90a38862026-06-04WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEGeri-Care Pharmaceuticals, Corp99eb67ca-301c-dfdb-e053-2a95a90aff6f2026-05-28WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECVS PHARMACY, INC1f9e72dc-a394-420d-8fe8-fc4d0f6906ed2026-05-27WarningsExact identifier
application number: M007
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy9983095a-6ef4-4ad7-acc5-e34221fb7c632026-05-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS PHARMACY, INC056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a1382026-05-20WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDES 8.8MG/5MLAldama Pharmaceuticals, Inc491255c6-465f-a78a-e063-6394a90aa4082026-05-15WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES AND DOCUSATE SODIUMCardinal Health 107, LLC40385b89-a855-4ca2-992a-df5eb677be152026-05-15WarningsExact identifier
application number: M007
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticalscc8d1556-f108-4166-837c-48f81152877e2026-05-12WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEGOODSENSEa9509715-cc4f-595d-e053-2a95a90ae31f2026-05-11WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCee14dfe2-405f-493a-a774-ce1b01d05dd42026-05-05WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895966glycerin 2.8 GM in 2.7 mL EnemaPSN4e15f6ca-a40c-485f-be3f-07c2ed7cb49811
1190433Pedia-Lax Liquid Glycerin Suppositories 2.8 GM in 2.7 mL EnemaPSN4e15f6ca-a40c-485f-be3f-07c2ed7cb49811
1190433glycerin 1037 MG/ML Enema [Pedia-Lax Liquid Glycerin Suppositories]SBD4e15f6ca-a40c-485f-be3f-07c2ed7cb49811
895966glycerin 1037 MG/ML EnemaSCD4e15f6ca-a40c-485f-be3f-07c2ed7cb49811
895966glycerin 2.8 GM per 2.7 ML EnemaSY4e15f6ca-a40c-485f-be3f-07c2ed7cb49811
1190433Pedia-Lax Liquid Glycerin Suppositories 2.8 GM per 2.7 ML EnemaSY4e15f6ca-a40c-485f-be3f-07c2ed7cb49811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0132-0190-12001320190126 APPLICATOR in 1 CARTON (0132-0190-12) / 4 mL in 1 APPLICATOR6 applicator2008-03-010000-00-00NoNoCurrent