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Pure and Gentle Laxative sodium phosphate 7 g/118mL; 19 g/118mL Enema — NDC 53329-0014-58 package photo

Pure and Gentle Laxative sodium phosphate 7 g/118mL; 19 g/118mL Enema

by Medline Industries, LP · 24 BOTTLE in 1 CASE (53329-014-58) / 133 mL in 1 BOTTLE
NDC 53329-0014-58
🏷️ FDA NDC (as labeled) 53329-014-58 billing pads the product segment with a zero
This package
Contains133 mL in 1 bottle Pack sizes2 compare ↓
Also comes in: 133 mL 53329-0014-11
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) 53329-014-58
Product NDC 53329-014
11-digit billing NDC 53329001458
RxCUI 283100
UNII GR686LBA74, 3980JIH2SW
Application # M007
SPL Set ID e3165538-75dd-4f0f-adc8-d4075de10f1e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-04-09
Route RECTAL
Dosage form ENEMA
Substance SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
GPI-14 46109902105100
GPI class Pure & Gentle Enema
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 PURE AND GENTLE SALINE ENEMA
FDB brand name Pure And Gentle Saline Enema
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 53329-014-58 — 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 → 53329-0014-58. 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

LabelerMedline Industries, LP
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code53329
First marketedApr 2014
Product typeHuman Otc Drug
Portfolio118 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 PURE AND GENTLE SALINE ENEMA Ingredient Sodium Phosphate,Mono-Dibasic
📗 Our plain-language guide HelloPharmacist
  • Most people feel the urge to go within 1 to 5 minutes after using the enema. If you don't feel anything after 5 minutes, try heading to the bathroom anyway. If no liquid has come o...
  • No — using more than one enema in a 24-hour period can be harmful. Too much sodium phosphate can throw off your body's fluid and mineral balance and cause serious side effects. If...
  • Can I use two of these if one doesn't seem to work?
  • You'll want to check with your doctor before using it. Kidney disease, heart problems, and dehydration all raise your risk of complications with this product. The same goes if you'...
📖 Read our full Sodium Phosphate Rectal guide →
2
Nutrient depletion considerations

Sodium Phosphate (OTC drug) may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Sodium Phosphate (OTC drug) nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.
Try another pack size: 133 mL
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/118mLthis 53329-0014-58 Medline 24 bottles — — 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

🏛️
2014
On the market since
Apr 2014
📍
2026
Currently FDA-listed
12 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 Pure and Gentle Laxative (this brand).

Top reported reactions

Nausea190
Vomiting178
Constipation159
Anaemia155
Sepsis153
Abdominal Pain141
Condition Aggravated139

Age at onset

Infant3
Child22
Adolescent20
Adult145
Elderly192

Reporter sex

1,710 reports
Male · 54%
Female · 46%

Serious outcomes

Hospitalization1,069
Death413
Disabling163
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 184 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
53329-0014-11 1 BOTTLE in 1 BOX (53329-014-11) / 133 mL in 1 BOTTLE 2017-11-10 Active
53329-0014-58 You're viewing this 24 BOTTLE in 1 CASE (53329-014-58) / 133 mL in 1 BOTTLE 2017-11-03 Active

Pack size FAQ

What quantity is in NDC 53329-0014-58?
NDC 53329-0014-58 is listed by the FDA — 24 bottle in 1 case / 133 ml in 1 bottle.
What NDC number is used to bill for this package of Pure and Gentle Laxative sodium phosphate 7 g/118mL; 19 g/118mL Enema?
Bill NDC 53329-0014-58 — the 11-digit billing format is 53329001458. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 53329-014-58, 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: 53329-0014-58, written without dashes as 53329001458. 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 53329-0014-58, the first segment (53329) is the labeler code FDA assigned to Medline Industries, LP; the middle segment (0014) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (58) 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 Medline Industries, LP. 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 1 other package presentation of this same product, including 1 bottle (53329-0014-11). 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?
Medline Industries, LP 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 ~3 min read ▾

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 & children 12 years and over 1 bottle once daily children 2 to under 12 years Use Pediatric Enema children under 2 years DO NOT USE CAUTION: Remove protective shield from enema tip before inserting.

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove. Positions for using this enema: Left-side position: lie on left side with knee bent and arms at rest.

Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably. Administering enema: With steady pressure, gently insert enema tip into rectum with a slight side to side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement.

Doing so helps relax muscles around anus. Do not force enema tip into rectum. Stop using if tip is hard to insert.

Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care. Squeeze bottle until nearly all liquid is gone.

It is not necessary to empty unit completely, as it containsmore liquid than needed. Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes). 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. Remove protective shield illustration Left Side position illustration Knee-chest position illustration 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 old and older 1 bottle once daily Children 2 to under 12 years old Use Pediatric Enema Children under 2 years DO NOT USE CAUTION: Remove protective shield from enema tip before inserting. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.

Positions for using this enema: Left-side position: Lie on left side with knees bent and arms resting comfortably. Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably. Administering enema: With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel.

Insertion may be easier if person receiving enema bears down, as if having a bowel movement. Doing so helps relax muscles around anus. Do not force enema tip into rectum.

Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.

Squeeze bottle until nearly all liquid is gone. It is not necessary to empty bottle completely, as it contains more liquid than needed. Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes).

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. image 1 image 2 image 3

⚠️ 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 symtoms of dehydration (thirstiness, dissiness, vomiting, urinating less oftan than normal) These symptoms may indicate a serious condition. If pregnant or breastfeeding, 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: 1-800-222-1222.

📦 Storage and Handling 38 words ▾

Other Information each 118 mL contains sodium 4.3 g store at15-30°C (59-86°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 18 words ▾

Active ingredient (in each 118 mL delivered dose) Dibasic sodium phosphate 7 g Monobasic sodium phosphate 19 g

🧪 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 ↗
← 53329-0013-11 · Medline 53329-0030-13 · Medline →
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.