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Relief SODIUM PHOSPHATE, MONOBASIC and SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 19 g/133mL; 7 g/133mL Enema — NDC 69626-0084-06 package photo

Relief SODIUM PHOSPHATE, MONOBASIC and SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 19 g/133mL; 7 g/133mL Enema

by Leosons Overseas Corp · 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69626-0084-6) / 133 mL in 1 BOTTLE, WITH APPLICATOR
NDC 69626-0084-06
🏷️ FDA NDC (as labeled) 69626-0084-6 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 69626-0084-6
Product NDC 69626-0084
11-digit billing NDC 69626008406
UNII 3980JIH2SW, 70WT22SF4B
Application # M007
SPL Set ID 5b301d5b-1e2c-47ed-a05f-d6be0fdfc940
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-02-09
Route RECTAL
Dosage form ENEMA
Substance SODIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
Why two NDCs? The FDA registers this code as 69626-0084-6 — 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 → 69626-0084-06. 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 marketedFeb 2015
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?

This is an over-the-counter enema product containing sodium phosphate salts (monobasic and dibasic forms). Sodium phosphates are salts that are typically used as osmotic laxatives, which work by drawing water into the bowel to help soften stool and promote bowel movements. This rectal enema form is commonly used to relieve occasional constipation or to cleanse the bowel before medical procedures.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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
Relief 19 g/133mL; 7 g/133mLthis 69626-0084-06 Leosons 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

🏛️
2015
On the market since
Feb 2015
📍
2026
Currently FDA-listed
11 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.

🔬 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 Relief (this brand).

Top reported reactions

Dyspnoea85
Fatigue84
Pain81
Pruritus78
Dizziness69
Headache68
Cough65

Age at onset

Infant1
Child1
Adolescent1
Adult96
Elderly92

Reporter sex

1,003 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization336
Death125
Life-threatening46
Disabling28
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 110 0
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 NDCDescription Marketing startStatus
69626-0084-06 You're viewing this 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69626-0084-6) / 133 mL in 1 BOTTLE, WITH APPLICATOR 2015-02-09 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 69626-0084-6, 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: 69626-0084-06, written without dashes as 69626008406. 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 69626-0084-06, the first segment (69626) is the labeler code FDA assigned to Leosons Overseas Corp; the middle segment (0084) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) 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 and Cautions ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 6 words ▾

Use for relief of occasional constipation

⏱️ Dosage and Administration 51 words ▾

Directions Single daily dosage. Do not use more unless directed by a doctor. See Warnings . Do not use if taking another sodium phosphates product. Adults and Children 12 years and over 1 Bottle Children 2 to under 12 years 1/2 Bottle once daily Children under 2 years DO NOT USE

⚠️ Warnings and Cautions 13 words ▾

Dosage Warning: Using more than one enema in 24 hours can be harmful.

⚠️ Warnings 151 words ▾

Warnings For rectal use only Dosage Warning: Using more than one enema in 24 hours can be harmful. Ask a doctor before using this product if you are on a sodium-restricted diet have kidney disease are 65 or older and under a doctor's care for any medical condition Ask a doctor before using any laxative if you have 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 Stop use and ask a doctor if you have rectal bleeding no bowel movement within 30 minutes of enema use symptoms of dehydration (feeling thirsty, 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.

📦 Storage and Handling 63 words ▾

Other information each 118 mL delivered dose contains: sodium 4.4 g additional liquids by mouth are recommended while using this product this product generally produces a bowel movement in 1-5 minutes store between 15°- 30°C (59°- 86°F) carton sealed for safety. Do not use if top or bottom flap of carton is torn or missing. consult PHYSICIANS' DESK REFERENCE® for complete professional labeling.

🧪 Active Ingredient 27 words ▾

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

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients Benzalkonium chloride, disodium EDTA, purified water

🎯 Purpose 23 words ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69626-0077-06 · Leosons 69626-0085-07 · 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.