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Saline Enema Sodium Phosphate Monobasic, Sodium Phosphate Dibasic 7 g/118mL; 19 g/118mL Enema — NDC 67777-0402-02 package photo

Saline Enema Sodium Phosphate Monobasic, Sodium Phosphate Dibasic 7 g/118mL; 19 g/118mL Enema

by Dynarex Corporation · 48 BOX in 1 CASE (67777-402-02) / 1 BOTTLE in 1 BOX (67777-402-01) / 118 mL in 1 BOTTLE
NDC 67777-0402-02
🏷️ FDA NDC (as labeled) 67777-402-02 billing pads the product 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

🚨
Active recall for this product.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0203-2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 67777-402-02
Product NDC 67777-402
11-digit billing NDC 67777040202
NCPDP billing unit ML — per mL (volume)
RxCUI 283100
UNII GR686LBA74, 3980JIH2SW
UPC 0616784471914
Application # M007
SPL Set ID 7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-08-29
Route RECTAL
Dosage form ENEMA
Substance SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
GPI-14 46109902125100
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 67777-402-02 — a 5-3-2 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 product segment → 67777-0402-02. 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

LabelerDynarex Corporation
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code67777
First marketedAug 2012
Product typeHuman Otc Drug
Portfolio60 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

Label name ENEMA READY TO USE Ingredient Sodium Phosphate,Mono-Dibasic
🧪 What is this product?

This is an over-the-counter rectal enema containing sodium phosphate salts (monobasic and dibasic forms). The sodium phosphate ingredients function as osmotic laxatives, drawing water into the bowel to help soften stool and promote bowel movements. Saline enemas of this type are typically used to relieve occasional constipation and to empty the colon 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.

💡 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 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/118mLthis 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

🏛️
2012
On the market since
Aug 2012
📍
2026
Currently FDA-listed
14 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 Saline Enema (this brand).

Top reported reactions

Pneumatosis Intestinalis2
Cerebral Haemorrhage1
Communication Disorder1
Fall1
Haemorrhage Intracranial1
Muscular Weakness1
Pupil Fixed1

Reporter sex

3 reports
Male · 100%

Serious outcomes

Death1
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
67777-0402-02 You're viewing this 48 BOX in 1 CASE (67777-402-02) / 1 BOTTLE in 1 BOX (67777-402-01) / 118 mL in 1 BOTTLE 2012-08-29 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 67777-402-02, 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: 67777-0402-02, written without dashes as 67777040202. 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 67777-0402-02, the first segment (67777) is the labeler code FDA assigned to Dynarex Corporation; the middle segment (0402) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Dynarex Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dynarex Corporation 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 19 words ▾

Uses • For relief of occasional constipation • This product generally produces bowel movement in 2 to 15 minutes

⏱️ Dosage and Administration 38 words ▾

Directions Adults and children 12 years old and over - 1 bottle once daily Children 2 to under 12 years of age - 1/2 bottle once daily, discard unused portion Children under 2 years - Consult a physician.

⚠️ Warnings 140 words ▾

Warnings: For rectal use only Dosage Warning: Using more than one enema in 24 hours can be harmful. Do not use • Laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor • Longer than 1 week unless directed by a doctor • This product if you are on a low salt diet unless directed by a doctor • This product if you have kidney disease unless directed by a doctor Ask a doctor before use if you have: Noticed a sudden change in bowel habits that persists over a period of 2 weeks Stop use and ask a doctor if: If you have rectal bleeding or fail to have a bowel movement after use Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 17 words ▾

Active Ingredients ( in each 118 mL delivered dose) Dibasic Sodium Phosphate 7g Monobasic Sodium Phosphate 19g

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients Benzalkonium Chloride, Disodium EDTA, Purified Water

🎯 Purpose 3 words ▾

Purpose Saline Laxative

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 67777-0319-01 · Dynarex 67777-0403-02 · Dynarex →
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.