Home › NDC Lookup › Ingredients › Saline Laxative › 00904-6320-78
Saline Laxative 7 g/133mL; 19 g/133mL Enema, 133 mL — NDC 00904-6320-78 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Saline Laxative 7 g/133mL; 19 g/133mL Enema, 133 mL — NDC 0904-6320-78 (Billing 00904-6320-78)

by Major Pharmaceuticals · 133 mL in 1 BOTTLE

This is a package of 133 mL of Saline Laxative 7 g/133mL; 19 g/133mL Enema from Major Pharmaceuticals, marketed since Jul 2013 and currently FDA-listed, this package's marketing is listed to end Apr 2027; retail pharmacies pay about $0.0067 per mL (NADAC). It is this product's only package size.

NDC 00904-6320-78
🏷️ FDA NDC (as labeled) 0904-6320-78 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0904-6320-78
Product NDC 0904-6320
11-digit billing NDC 00904632078
NCPDP billing unit ML — per mL (volume)
RxCUI 283100
UNII GR686LBA74, 3980JIH2SW
Application # M007
SPL Set ID b3758ffe-1bac-4df6-9714-5e33e9d28d90
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-07-11
Marketing end 2027-04-30
Route RECTAL
Dosage form ENEMA
Substance SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 46109902105100
GPI class 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 ENEMA READY TO USE
FDB brand name Enema
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 003029
  • GCN: 66559
  • GPI-14 (Medi-Span): 46109902105100
  • HICL (First Databank): 001330
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 283100
Why two NDCs? The FDA registers this code as 0904-6320-78 — a 4-4-2 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 labeler segment → 00904-6320-78. 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.

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 (dibasic and monobasic forms) as its active ingredients. Sodium phosphate is a saline laxative typically used to draw water into the colon and stimulate bowel movements. The product is administered rectally and is marketed under the FDA's over-the-counter monograph rules for laxative enemas. It is intended for occasional use to relieve constipation.

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.

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 mLPer package
Retail pharmacies payNADAC · weekly $0.007 $0.89 / 133 ml
Medicaid paysCMS SDUD · 12 mo $0.0275 $3.66 / 133 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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.008 $0.006
▲ Up 5% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00904-6320-78 You're viewing this Main listing 133 mL in 1 BOTTLE 2013-07-11 Apr 30, 2027 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sunmark Saline Single Laxative 7 g/118mL; 19 g/118mL 49348-0186-14 Strategic 2 bottles $0.007 — FDA listed save 2%
Saline Laxative 7 g/133mL; 19 g/133mLthis 00904-6320-78 Major 133 ml $0.007 — Availability likely —
Foster and Thrive Ready to Use Saline Laxative 7 g/118mL; 19 g/118mL 70677-1089-01 McKesson 1 bottle $0.007 — Availability likely —
Quality Choice Laxative 7 g/118mL; 19 g/118mL 83324-0292-45 Chain 1 bottle $0.007 — Availability likely —
Quality Choice Laxative 7 g/118mL; 19 g/118mL 83324-0293-90 Chain 2 bottles $0.007 — Availability likely —
HealthMart Saline Single Laxative 7 g/118mL; 19 g/118mL 62011-0271-01 Strategic 1 bottle $0.008 — FDA listed +21%
Leader Ready to Use Saline Laxative 7 g/118mL; 19 g/118mL 70000-0108-01 Cardinal 1 bottle $0.008 — FDA listed +21%
Fleet 7 g/118mL; 19 g/118mL 00132-0201-40 C.B. 133 ml $0.010 — Availability likely +42%
Pedia-Lax 3.5 g/66mL; 9.5 g/66mL 00132-0202-20 C.B. 66 ml $0.020 — Availability likely +205%
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
Jul 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.

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.

Manufacturer & labeler

LabelerMajor Pharmaceuticals
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedJul 2013
Product typeHuman Otc Drug
Portfolio630 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.

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 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 ~1 min read ▾

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 47 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

📄 Do Not Use 11 words ▾

Do not use ▪ on children under 2 years of age

📄 Ask a Doctor Before Use If 62 words ▾

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 33 words ▾

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 32 words ▾

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 45 words ▾

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 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

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

📄 Questions or Comments 5 words ▾

Questions or comments? (800) 616-2471

📄 Package Label / Principal Display Panel 52 words ▾

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton MAJOR ® NDC 0904-6320-78 Compare to the active ingredients of Fleet ® Saline Enema* Ready-to-Use Enema Saline Laxative For relief of occasional constipation Not made with natural rubber latex

4.5 FL OZ (133 mL) 1 Bottle PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

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

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 this package alone, 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 – Q1 2026 · 5 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
585
Units reimbursed last 4 qtrs
302.1K
Gross reimbursed last 4 qtrs
$8.3K
Avg / prescription
$14.18
Avg / unit
$0.0275
Latest quarter Q1 2026
107Rx
Medicaid pays / mL
$0.0275
gross reimbursed
vs
NADAC / mL
$0.0067
acquisition cost
=
Spread
+$0.0208
+310% 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 ⓘ
90% FFS
Fee-for-service · 526 Rx Managed care · 59 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 218,254 units · 1,115 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 49,875 units · 385 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 30,067 units · 77.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 3,857 units · 12.6 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
12.61,115
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 New York 1,115 /100k
2 Pennsylvania 385 /100k
3 California 77.2 /100k
4 Texas 12.6 /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.
← 00904-6312-56 · Major 00904-6322-06 · Major →
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.