NDC 70000-0108-02 — Leader Ready to Use Saline Laxative Sodium

🆔 Identity & classification

FDA NDC (as labeled) 70000-0108-2

Product NDC 70000-0108

11-digit billing NDC 70000010802

NCPDP billing unit ML — per mL (volume)

RxCUI 283100

UNII GR686LBA74, 3980JIH2SW

Application # M007

SPL Set ID 1b4f9c28-0547-4922-aa15-990c6fd9dc9f

Mechanism of action Osmotic Activity

Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2013-02-19

Marketing end 2027-02-28

Route RECTAL

Dosage form ENEMA

Substance SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

GPI-14 46109902125100

GPI class Enema Ready-To-Use

GCN Seq No 003029

GCN 66559

HICL code 001330

Ingredient (HICL) Sodium Phosphate,Mono-Dibasic

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q3

Therapeutic class — intermediate (HIC2) Anal-Rectal Preparations

HIC3 code Q3S

Therapeutic class — specific (HIC3) Laxatives, Local/Rectal

AHFS code 56:12.00.00

AHFS class Cathartics And Laxatives

FDB label name ENEMA READY TO USE

FDB brand name Enema

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 70000-0108-2 — a 5-4-1 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 package segment → 70000-0108-02. 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.

🏭 Manufacturer & labeler

LabelerCardinal Health

FDA applicationM007 (OTC MONOGRAPH DRUG)

Labeler code70000

First marketedFeb 2013

Product typeHuman Otc Drug

Portfolio84 products on file

🔎 All NDCs from Cardinal Health

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 ENEMA READY TO USE Ingredient Sodium Phosphate,Mono-Dibasic

🧪 What is this product?

This is an over-the-counter enema product containing sodium phosphate salts, marketed under FDA's established rules for laxative products. The two forms of sodium phosphate work together as osmotic laxatives, drawing water into the bowel to soften stool and promote bowel movement. It is administered rectally and is typically used to relieve occasional constipation or to prepare the bowel before medical procedures. This is an OTC monograph drug, meaning it follows a standard FDA category rule rather than an individual product application.

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

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.

🧪 Inactive Ingredients / Excipients

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 8NLQ36F6MM
Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
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 mL	Per package
Retail pharmacies payNADAC · weekly	$0.007	$1.73 / 266 ml
Medicaid paysCMS SDUD · 12 mo	$0.0386	$10.27 / 266 ml
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 25% 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Saline Laxative 7 g/133mL; 19 g/133mL 00904-6320-78	Major	133 ml	$0.006	—	Availability likely	save 2%
Foster and Thrive Ready to Use Saline Laxative 7 g/118mL; 19 g/118mL 70677-1089-01	McKesson	1 bottle	$0.006	—	Availability likely	save 2%
Quality Choice Laxative 7 g/118mL; 19 g/118mL 83324-0292-45	Chain	1 bottle	$0.006	—	Availability likely	save 2%
Quality Choice Laxative 7 g/118mL; 19 g/118mL 83324-0293-90	Chain	2 bottles	$0.006	—	Availability likely	save 2%
Sunmark Saline Single Laxative 7 g/118mL; 19 g/118mL 49348-0186-14	Strategic	2 bottles	$0.007	—	FDA listed	—
Leader Ready to Use Saline Laxative 7 g/118mL; 19 g/118mLthis 70000-0108-02	Cardinal	2 bottles	$0.007	—	FDA listed	—
HealthMart Saline Single Laxative 7 g/118mL; 19 g/118mL 62011-0271-01	Strategic	1 bottle	$0.008	—	FDA listed	+24%
Fleet 7 g/118mL; 19 g/118mL 00132-0201-40	C.B.	133 ml	$0.010	—	Availability likely	+46%
Pedia-Lax 3.5 g/66mL; 9.5 g/66mL 00132-0202-20	C.B.	66 ml	$0.020	—	Availability likely	+213%
Saline Laxative 7 g/118mL; 19 g/118mL 00363-0005-37	Walgreen	1 bottle	—	—	FDA listed	—
Equate Ready-to-Use Enema Laxative 7 g/118mL; 19 g/118mL 49035-0002-24	WalMart	6 bottles	—	—	FDA listed	—
Pure and Gentle Laxative 7 g/118mL; 19 g/118mL 53329-0014-11	Medline	1 bottle	—	—	FDA listed	—
Freds Saline Twin Pack Laxative 7 g/133mL; 19 g/133mL 55315-0301-01	FRED'S	2 bottles	—	—	FDA listed	—
Rexall Ready to use 4pk LAXATIVE 7 g/118mL; 19 g/118mL 55910-0999-06	Dolgencorp,	4 bottles	—	—	FDA listed	—
CVS Pharmacy 7 g/118mL; 19 g/118mL 59779-0959-11	CVS	1 bottle	—	—	FDA listed	—
NATUREPLEX Enema 19 g/133mL; 7 g/133mL 67234-0020-01	Natureplex,	1 bottle	—	—	FDA listed	—
Saline Enema 7 g/118mL; 19 g/118mL 67777-0402-02	Dynarex	1 bottle	—	—	FDA listed	—
Reflief Saline Laxative Pediatric Ready To Use 3.5 g/59mL; 9.5 g/59mL 69626-0085-07	Leosons	1 bottle	—	—	FDA listed	—
Quality Choice Single Saline Laxative 7 g/118mL; 19 g/118mL 71443-0001-06	Alcyon	6 bottles	—	—	FDA listed	—
Pro-Enema Single Saline Laxative 7 g/118mL; 19 g/118mL 71451-0001-01	Propharma	1 bottle	—	—	FDA listed	—

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

🏛️

2013

On the market since

Feb 2013

📍

2026

Currently FDA-listed

13 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 70000-0108-02, 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

73

Units reimbursed last 4 qtrs

22.7K

Gross reimbursed last 4 qtrs

$876.27

Avg / prescription

$12.00

Avg / unit

$0.0386

Latest quarter Q4 2025

0Rx

Medicaid pays / mL

$0.0386

gross reimbursed

vs

NADAC / mL

$0.0065

acquisition cost

=

Spread

+$0.0321

+494% 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 ⓘ

100% FFS

Fee-for-service · 73 Rx Managed care · 0 Rx

State Medicaid map

Units reimbursed · per 100k residents

17.0175

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

🏆 Top states by units · per 100k residents

1 Massachusetts 175 /100k

2 Washington 49.4 /100k

3 California 17.0 /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.

1 bottle70000-0108-01 266 Rx · $3,599

2 bottles this page70000-0108-02 73 Rx · $876

Drug total (last 4 qtrs): 339 Rx · 149,491 units · $4,475 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
70000-0108-01	1 BOTTLE in 1 CARTON (70000-0108-1) / 133 mL in 1 BOTTLE	$0.0081 / mL	$1.07	2013-02-19	Active
70000-0108-02 You're viewing this	2 BOTTLE in 1 CARTON (70000-0108-2) / 133 mL in 1 BOTTLE	$0.0065 / mL	$1.74	2013-02-19	Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.0065 NADAC).

This pack accounts for about 22% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 70000-0108-02?

NDC 70000-0108-02 is listed by the FDA — 2 bottle in 1 carton / 133 ml in 1 bottle.

What NDC number is used to bill for this package of Leader Ready to Use Saline Laxative Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form 7 g/118mL; 19 g/118mL Enema?

Bill NDC 70000-0108-02 — the 11-digit billing format is 70000010802. 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.

📄 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.

🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 15 words ▾

Use relieves occasional constipation this product generally produces bowel movement in 1 to 5 minutes

⏱️ Dosage and Administration 67 words ▾

Directions (or as directed by a doctor) Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings . Adults and children 12 years of age and older 1 bottle once daily Children 2 to under 12 years of age Use Pediatric Enema Children under 2 years of age DO NOT USE

⚠️ Warnings 219 words ▾

Warnings Dosage warning Using more than one enema in 24 hours can be harmful. For rectal use only. Do not use on children under 2 years of age Ask a doctor before use if you have already used a laxative for more than 3 days have kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea, or vomiting have a sudden change in bowel habits lasting more than 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug.

Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product do not use more than directed.

Serious side effects may occur from excess dosage do not use for more than 3 days, without asking a doctor Stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

📦 Storage and Handling 43 words ▾

Other information each 118 ml contains sodium 4.3 g store at 15 to 30°C (59 to 86°F) additional liquids by mouth are recommended while using this product Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

🧪 Active Ingredient 22 words ▾

Active ingredients (in each 118mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients benzalkonium chloride, disodium EDTA, purified water

🎯 Purpose 22 words ▾

Active ingredients (in each 118mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form NDCsSame ingredient 🏭 All Cardinal labeler NDCsLabeler code 70000

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Laxatives, Local/Rectal.

Glycerin 00132-0079-00 Mineral Oil 00132-0301-40 Bisacodyl 00132-0703-36 Potassium Bitart/Sodium Bicarb 00283-0808-12 Docusate Sodium 00904-6920-93 Docusate Sodium/Benzocaine 17433-9877-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.