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REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM and SODIUM PHOSPHATE, MONOBASIC, 3.5 g/59mL; 9.5 g/59mL Enema — NDC 69626-0085-07 package photo

REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM and SODIUM PHOSPHATE, MONOBASIC, 3.5 g/59mL; 9.5 g/59mL Enema

by Leosons Overseas Corp · 1 BOTTLE, PLASTIC in 1 CARTON (69626-0085-7) / 67 mL in 1 BOTTLE, PLASTIC
NDC 69626-0085-07
🏷️ FDA NDC (as labeled) 69626-0085-7 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 69626-0085-7
Product NDC 69626-0085
11-digit billing NDC 69626008507
RxCUI 283100
UNII GR686LBA74, 3980JIH2SW
Application # M007
SPL Set ID 90e7c2b4-35e1-4a27-afea-9257c480e190
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-01
Route RECTAL
Dosage form ENEMA
Substance SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Why two NDCs? The FDA registers this code as 69626-0085-7 — 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 → 69626-0085-07. 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

LabelerLeosons Overseas Corp
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code69626
First marketedOct 2019
Product typeHuman Otc Drug
Portfolio13 products on file
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

🧪 What is this product?

ReliEf Saline Laxative Pediatric is a ready-to-use rectal enema containing sodium phosphate salts (dibasic and monobasic forms). These salts are commonly used in enema products to draw water into the colon, which typically helps soften stool and promote bowel movements. This product is an OTC monograph drug, meaning it is marketed under FDA's established rulebook for laxative enemas rather than as an individually reviewed medication.

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 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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Saline Laxative 7 g/133mL; 19 g/133mL 00904-6320-78 Major 133 ml $0.006 — Availability likely —
Foster and Thrive Ready to Use Saline Laxative 7 g/118mL; 19 g/118mL 70677-1089-01 McKesson 1 bottle $0.006 — Availability likely —
Quality Choice Laxative 7 g/118mL; 19 g/118mL 83324-0292-45 Chain 1 bottle $0.006 — Availability likely —
Quality Choice Laxative 7 g/118mL; 19 g/118mL 83324-0293-90 Chain 2 bottles $0.006 — Availability likely —
Sunmark Saline Single Laxative 7 g/118mL; 19 g/118mL 49348-0186-14 Strategic 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 —
Leader Ready to Use Saline Laxative 7 g/118mL; 19 g/118mL 70000-0108-01 Cardinal 1 bottle $0.008 — FDA listed —
Fleet 7 g/118mL; 19 g/118mL 00132-0201-40 C.B. 133 ml $0.010 — Availability likely —
Pedia-Lax 3.5 g/66mL; 9.5 g/66mL 00132-0202-20 C.B. 66 ml $0.020 — Availability likely —
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/59mLthis 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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69626-0085-07 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (69626-0085-7) / 67 mL in 1 BOTTLE, PLASTIC 2019-10-01 Active

🧭 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 NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 69626-0085-7, 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: 69626-0085-07, written without dashes as 69626008507. 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 69626-0085-07, the first segment (69626) is the labeler code FDA assigned to Leosons Overseas Corp; the middle segment (0085) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 Leosons Overseas Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Leosons Overseas Corp 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 15 words ▾

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

⏱️ Dosage and Administration 56 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 . children 2 to under 12 years of age Use 1 bottle once daily children under 2 years of age DO NOT USE

⚠️ Warnings 203 words ▾

Warnings For rectal use only. Dosage warning: Using more than one enema in 24 hours can be harmful. Do not use on children under 2 years of age Ask a doctor before use if the child has already used a laxative for more than 3 days has kidney disease, have heart problems, or are dehydrated is on a sodium-restricted diet has abdominal pain, nausea, or vomiting has a sudden change in bowel habits lasting more than 2 weeks Ask a doctor or pharmacist before use if the child is 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 the child has rectal bleeding has no bowel movement within 30 minutes of enema use has symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal). These symptoms may indicate a serious condition. 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 42 words ▾

Other information each 59 mL contains 2.2g sodium 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 25 words ▾

Active ingredients & Purpose Active ingredients (in each 59 ml delivered dose) Purpose Dibasic Sodium Phosphate 3.5g..... Saline laxative Monobasic Sodium Phosphate 9.5g..... Saline laxative

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients benzalkonium chloride, disodium EDTA, purified water

🎯 Purpose 21 words ▾

Active ingredients (in each 59 ml delivered dose) Purpose Dibasic Sodium Phosphate 3.5g..... Saline laxative Monobasic Sodium Phosphate 9.5g..... Saline laxative

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69626-0084-06 · Leosons 69626-5200-09 · Leosons →
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.