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 ENEMA
FDB brand nameEnema
Legend statusO — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0132-0201-45 — 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 → 00132-0201-45. 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.
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 ENEMAIngredient Sodium Phosphate,Mono-Dibasic
🧪 What is this product?
Fleet sodium phosphate enema is an over-the-counter rectal solution containing sodium phosphate salts (dibasic and monobasic forms). This product is marketed as an OTC monograph drug, meaning it follows an established FDA rule-book for its category rather than an individual application review. Sodium phosphates in enema form are typically used as osmotic laxatives, drawing water into the bowel to promote bowel movement and relieve constipation.
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 sodium phosphate, dibasic and sodium phosphate, monobasic?
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 F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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.
3 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesbenzalkonium chloride, disodium EDTA, 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 each
Per package
Retail pharmacies payNADAC · weekly
Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo
$0.0159
$0.02 / 1 bottle
Medicare drug plans payPart D · quarterly
No Part D plan price is available for this NDC in our data.
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
🏛️
1953
On the market since
Mar 1953
📍
2026
Currently FDA-listed
73 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 00132-0201-45, 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 – Q1 2026 · 5 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
942
Units reimbursed last 4 qtrs
943.4K
Gross reimbursed last 4 qtrs
$15K
Avg / prescription
$15.95
Avg / unit
$0.0159
Latest quarter Q1 2026
257Rx
Fee-for-service vs managed care ⓘ
91% FFS
Fee-for-service · 854 Rx Managed care · 88 Rx
State Medicaid map
Units reimbursed · per 100k residents
1193,114
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
1New York3,114 /100k
2California564 /100k
3Pennsylvania470 /100k
4Ohio234 /100k
5Virginia156 /100k
6Michigan119 /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.
💊 Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 35,117 Rx · 21,101,609 units · $464,742 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
🔬 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 Fleet (this brand).
Top reported reactions
Nausea2,995
Constipation2,670
Fatigue2,386
Pain2,315
Vomiting2,180
Dyspnoea2,164
Diarrhoea1,917
Age at onset
Neonate16
Infant27
Child81
Adolescent72
Adult2,466
Elderly3,219
Reporter sex
Male · 44%
Female · 56%
Unknown · 0%
Serious outcomes
Hospitalization17,140
Life-threatening2,293
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.
230 mL in 1 BOTTLE, WITH APPLICATOR (0132-0201-10)
—
—
2004-06-25
Discontinued by firm
This pack accounts for about 2.7% of this product's recent Medicaid fills; most go to the 133 ml pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 00132-0201-45?
NDC 00132-0201-45 contains 133 mL — 133 ml in 1 bottle, with applicator.
What is the difference between NDC 00132-0201-45 and NDC 00132-0201-40?
Both are Fleet sodium phosphate, dibasic and sodium phosphate, monobasic 7 g/118mL; 19 g/118mL Enema — the drug itself is identical. NDC 00132-0201-45 is the 133 mL package, while NDC 00132-0201-40 is the 133 ml package.
What NDC number is used to bill for this package of Fleet sodium phosphate, dibasic and sodium phosphate, monobasic 7 g/118mL; 19 g/118mL Enema?
Bill NDC 00132-0201-45 — the 11-digit billing format is 00132020145. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes)
✓ Available
Labeler
✓ Available
Product & package description
✓ Available
Marketing category & status
✓ Available
Active ingredient / dosage form / route
✓ Available
FDA label (SPL via DailyMed)
✓ Available
Package photos
✓ Available
Inactive ingredients (structured)
✓ Available
NADAC pharmacy acquisition price (CMS)
— Not published for this NDCCMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data
— Not published for this NDCApplies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk
— Not published for this NDCMost self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)
✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0132-0201-45, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00132-0201-45, written without dashes as 00132020145. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00132-0201-45, the first segment (00132) is the labeler code FDA assigned to C.B. Fleet Company, Inc.; the middle segment (0201) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (45) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by C.B. Fleet Company, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 133 ml (00132-0201-40), 133 ml (00132-0201-42), 230 ml (00132-0201-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
C.B. Fleet Company, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 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.
Use for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes.
⏱️Dosage and Administration85 words▾
Directions Single Daily Dosage (per 24 hours) Do not use if taking another sodium phosphates product. Do not use more unless directed by a doctor. See Warnings. adults and children 12 years and over 1 bottle per day children 2 to 11 yearsuse Fleet® Pedia-Lax® Enema children under 2 yearsDO NOT USE If no urge is felt after 5 minutes of using, try to empty bowel.
Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
⚠️Warnings137 words▾
Warnings Using more than one enema in 24 hours can be harmful. For rectal use only. Do not use for more than 3 days if you have kidney disease if you have heart problems if you are dehydrated when abdominal pain, nausea, or vomiting are present unless directed by a doctor Ask a doctor before using this product if you are 55 years of age or older are on a sodium-restricted diet have a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week Stop use and ask a doctor if you have rectal bleeding no bowel movement or no liquid comes out of the rectum after 30 minutes symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal] These symptoms may indicate a serious condition.
🧪Active Ingredient18 words▾
Active Ingredient (in each 118 mL delivered dose) Monobasic Sodium Phosphate 19 g................ Dibasic Sodium Phosphate 7 g........................
🧪Inactive Ingredients8 words▾
Inactive Ingredients benzalkonium chloride, disodium EDTA, purified water
🎯Purpose5 words▾
Purpose Saline laxative Saline 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.
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.