Home NDC 0132-0195 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 Ingredient Strength GLYCERIN 2.8 g/4mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PDC6A3C0OX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 895966 Internal RxNorm lookup 1190433 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0132-0195-12 Pedia-Lax 4 mL in 1 APPLICATOR LIQUID 4 2 0132-0195-12 Pedia-Lax 6 in 1 CARTON LIQUID 6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0132-0195 PEDIA-LAX (GLYCERIN) LIQUID [C.B. FLEET COMPANY, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20241211_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 17 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0132-0195-12 00132019512 6 APPLICATOR in 1 CARTON (0132-0195-12) / 4 mL in 1 APPLICATOR 6 applicator 2019-02-01 0000-00-00 No No Current