Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy
⚠️
Other active recalls for Glycerin (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 27, 2026 — Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. (Oasis Medical, Inc.)· FDA recall D-0525-2026
Class II · Apr 20, 2026 — Lack of Assurance of Sterility (SCOPE HEALTH)· FDA recall D-0499-2026
Class II · Mar 25, 2026 — Lack of Assurance of Sterility (Preferred Pharmaceuticals, Inc.)· FDA recall D-0443-2026
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc)· FDA recall D-0411-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Established class (EPC)Non-Standardized Chemical Allergen
Physiologic effectIncreased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical classAllergens; Glycerol
DEA scheduleNon-controlled
Marketing categoryOTC MONOGRAPH DRUG
Marketing statusOn market
FDA listing statusListed (active directory)
Marketing start2008-03-01
RouteRECTAL
Dosage formLIQUID
SubstanceGLYCERIN
GPI-1446600010005264
GPI classPedia-Lax
GCN Seq No065949
GCN28087
HICL code001312
Ingredient (HICL)Glycerin
HIC1 codeQ
Therapeutic class — broad (HIC1)Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 codeQ3
Therapeutic class — intermediate (HIC2)Anal-Rectal Preparations
HIC3 codeQ3S
Therapeutic class — specific (HIC3)Laxatives, Local/Rectal
AHFS code56:12.00.00
AHFS classCathartics And Laxatives
FDB label nameFLEET PEDIA-LAX SUPPOSITORIES
FDB brand namePedia-Lax
Legend statusO — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0132-0190-12 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00132-0190-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️RxNorm drug class
This medicine belongs to the Non-Standardized Chemical Allergen class.
Pharmacologic classNon-Standardized Chemical Allergen
Drug family (ATC)Enemas, Other drugs for constipation
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name FLEET PEDIA-LAX SUPPOSITORIESIngredient Glycerin
🧪 What is this product?
Pedia-Lax Glycerin is a rectal liquid product sold over the counter under FDA's OTC monograph rules for laxatives. It contains glycerin, a substance that is typically used to ease bowel movements by drawing water into the intestines and lubricating stool. This form is commonly used for temporary relief of constipation in children and adults.
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about Glycerin?
Ask a licensed pharmacist directly — free, answered by our team.
Inactive ingredients, also called excipients, are components of the drug product
other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors,
or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
2 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesedetate disodium, purified water
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
Price system
Per mL
Per package
Retail pharmacies payNADAC · weekly
$0.209
—
Medicaid paysCMS SDUD · 12 mo
$0.2581
—
Medicare drug plans payPart D · quarterly
No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
▲ Up 10% over the last 13 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2008
On the market since
Mar 2008
📍
2026
Currently FDA-listed
18 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00132-0190-12, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.7K
Units reimbursed last 4 qtrs
151.5K
Gross reimbursed last 4 qtrs
$39.1K
Avg / prescription
$23.51
Avg / unit
$0.2581
Latest quarter Q4 2025
371Rx
Medicaid pays / mL
$0.2581
gross reimbursed
vs
NADAC / mL
$0.2090
acquisition cost
=
Spread
+$0.0491
+23% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
69% FFS31% MCO
Fee-for-service · 1,141 Rx Managed care · 523 Rx
State Medicaid map
Units reimbursed · per 100k residents
3.4864
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1Minnesota864 /100k
2Wisconsin359 /100k
3Connecticut317 /100k
4Montana316 /100k
5Nevada168 /100k
6Arizona158 /100k
7Tennessee99.9 /100k
8Pennsylvania96.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Pedia-Lax (this brand).
Top reported reactions
Constipation2,192
Nausea2,174
Pain2,028
Fatigue1,807
Dyspnoea1,674
Fall1,668
Diarrhoea1,514
Age at onset
Neonate19
Infant28
Child38
Adolescent46
Adult1,803
Elderly2,483
Reporter sex
Male · 42%
Female · 58%
Unknown · 0%
Serious outcomes
Hospitalization12,843
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
Package NDC
Description
Marketing start
Status
00132-0190-12 You're viewing this
4 LIQUID in 1 CARTON (0132-0190-12)
2008-03-01
Active
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
Uses for relief of occasional constipation this product usually produces bowel movement in 1/4 to 1 hour
⏱️Dosage and Administration208 words▾
Directions Single Daily Dosage (per 24 hours) children 2 to under 6 years 1 suppository per day or as directed by a doctor children under 2 years consult a doctor Administering the laxative: CAUTION: REMOVE ORANGE PROTECTIVE SHIELD BEFORE INSERTING. Hold unit upright, grasping bulb of unit with fingers. Grasp orange protective shield with other hand, pull gently to remove.
With steady pressure, gently insert tip into rectum with slight side-to-side movement, with tip pointing toward navel. Discontinue use if resistance is encountered. Forcing the tip can result in injury.
Insertion may be easier if child receiving suppository bears down as if having a bowel movement. This helps relax the muscles around the anus. Squeeze the bulb until nearly all liquid is expelled.
While continuing to squeeze the bulb, remove tip from rectum and discard unit. It is not necessary to empty unit completely. The unit contains more than the amount of liquid needed for effective use.
A small amount of liquid will remain in the unit after squeezing. Left-side position: Place child on left side with knees bent and arms resting comfortably. Knee-chest position: Have child kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.
⚠️Warnings115 words▾
Warnings For rectal use only . May cause rectal discomfort or a burning sensation. Ask a doctor before using any laxative if the child has abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week if constipation continues after one week of use, contact your child's doctor Stop using this product and consult a doctor if the child has rectal bleeding no bowel movement within 1 hour of using this product These s ymptoms may indicate a serious condition.
Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
🧪Active Ingredient12 words▾
Active Ingredient (in each 2.7 mL average delivered dose) Glycerin 2.8 g
🧪Inactive Ingredients6 words▾
Inactive Ingredients edetate disodium, purified water
🎯Purpose3 words▾
Purpose Hyperosmotic Laxative
No label section mentions that — try another word, or open the full label on DailyMed below.
Glossary — plain-language definitions of medical terms used in this label:
abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.
Active ingredient: The part of a medicine that produces its intended effect on the body.
constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.
suppository: A solid form inserted into the rectum or vagina, where it melts and is absorbed.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.
