Pedia-Lax

Product NDC
0132-0195
11-digit product format
001320195
Labeler code
0132
Product ID
0132-0195_e622c043-75e3-4c55-95dd-e243325b84dc
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
2019-02-01
Substance
GLYCERIN
Active strength
2.8 g/4mL
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
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
Pedia-Lax
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN2.8 g/4mL

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
ae367381-7146-4307-823d-2bb44c1d4200Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0195-12Pedia-Lax4 mL in 1 APPLICATORLIQUID42
0132-0195-12Pedia-Lax6 in 1 CARTONLIQUID62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0195PEDIA-LAX (GLYCERIN) LIQUID [C.B. FLEET COMPANY, INC.]2Current NDC, Legacy NDC, 2 package rows20241211_ae367381-7146-4307-823d-2bb44c1d4200.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 18 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHILLIPS FRESH MINT MILK OF MAGNESIAPHILLIPS FRESH MINT MILK OF MAGNESIABayer HealthCare LLC.0a59f9c3-c14e-2824-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M007
CVS Mini EnemaDOCUSATE SODIUM W/BENZOCAINECVS HEALTHca00c520-410a-1905-e053-2995a90a56f02025-12-04WarningsExact identifier
application number: M007
Docusate Mini EnemaDOCUSATE SODIUMMajor Pharmaceuticals91099e15-94d7-b684-e053-2a95a90a574e2025-12-04WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp1057c0bf-4bf6-ea17-e063-6294a90a59842025-12-04WarningsExact identifier
application number: M007
PHILLIPS ORIGINAL MILK OF MAGNESIAPHILLIPS ORIGINAL MILK OF MAGNESIABayer HealthCare LLC.0a57bb45-d4f7-443b-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M007
Equalactin LaxativeCALCIUM POLYCARBOPHILNUMARK BRANDS, INC2feed33a-3b7f-11c6-6e62-c99150ecfddd2025-12-03WarningsExact identifier
application number: M007
Gentle Laxative Stimulant LaxativeBISACODYLQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)bcd3c07d-bd83-4452-9736-35c85db30c152025-12-03WarningsExact identifier
application number: M007
Quality Choice Fiber LaxativePSYLLIUM HUSKQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)2ee637c4-c4c6-4a24-ae99-612205afd5922025-12-03WarningsExact identifier
application number: M007
Quality ChoiceCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f1e69c65-c1b0-459f-9a12-b1a92b90036b2025-12-03WarningsExact identifier
application number: M007
CDMA Fiber TherapyMETHYLCELLULOSECHAIN DRUG MARKETING ASSOCIATION62bbcaf2-1d0c-485f-9159-685700aa34182025-12-03WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMReliable 1 Laboratories LLC44fae161-3fc8-64c4-e063-6294a90a1d262025-12-02WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMRMT HEALTH LLC44fbb197-fe90-c5a8-e063-6394a90adb7d2025-12-02WarningsExact identifier
application number: M007
Fiber LaxCALCIUM POLYCARBOPHILRugby Laboratories318d81ed-0b06-4d21-8b97-2d1f0267c7812025-12-02WarningsExact identifier
application number: M007
Magnesium CitrateEPIC MEDICAL MAGNESIUM CITRATE ORAL SOLUTION - LEMON4 Visions LLC44fe65d0-ee46-1d95-e063-6294a90abb712025-12-02WarningsExact identifier
application number: M007
FIBER TABSCALCIUM POLYCARBOPHILMajor Pharmaceuticalsbee100da-b9c9-4261-b6e6-7b3db57156252025-12-02WarningsExact identifier
application number: M007
Quality Choice Stool SoftenerDOCUSATE SODIUMChain Drug Marketing Associationb1440ab7-a7d5-4153-8143-cffad73120f52025-12-02WarningsExact identifier
application number: M007
Walgreen Fiber LaxCALCIUM POLYCARBOPHILWALGREENS CO.9cbe1798-e0dc-4a90-bd91-8696fc59b2a62025-11-25WarningsExact identifier
application number: M007
Walgreens Fiber TherapyMETHYLCELLULOSEWALGREENS CO.6401a2c3-5869-4898-81db-3cd7151ca69a2025-11-25WarningsExact identifier
application number: M007
Walgreens Senna LaxativeSENNOSIDESWALGREENS CO.a95bd796-d85e-4599-bbb1-2170088fa9372025-11-25WarningsExact identifier
application number: M007
Walgreens Stool Softener Fruit PunchDOCUSATE SODIUMWALGREENS CO.8428c81d-227a-4b0f-9a47-71d6a69838422025-11-25WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895966glycerin 2.8 GM in 2.7 mL EnemaPSNae367381-7146-4307-823d-2bb44c1d42002
1190433Pedia-Lax Liquid Glycerin Suppositories 2.8 GM in 2.7 mL EnemaPSNae367381-7146-4307-823d-2bb44c1d42002
1190433glycerin 1037 MG/ML Enema [Pedia-Lax Liquid Glycerin Suppositories]SBDae367381-7146-4307-823d-2bb44c1d42002
895966glycerin 1037 MG/ML EnemaSCDae367381-7146-4307-823d-2bb44c1d42002
895966glycerin 2.8 GM per 2.7 ML EnemaSYae367381-7146-4307-823d-2bb44c1d42002
1190433Pedia-Lax Liquid Glycerin Suppositories 2.8 GM per 2.7 ML EnemaSYae367381-7146-4307-823d-2bb44c1d42002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0132-0195-12001320195126 APPLICATOR in 1 CARTON (0132-0195-12) / 4 mL in 1 APPLICATOR6 applicator2019-02-010000-00-00NoNoCurrent