OneLAX BISACODYL 10 mg Suppository, 12 suppositories
by AKRON PHARMA INC · 12 BLISTER PACK in 1 BOX (71399-8460-2) / 1 SUPPOSITORY in 1 BLISTER PACK
NDC 71399-8460-02
🏷️ FDA NDC (as labeled)
71399-8460-2
billing pads the package segment with a zero
This package
Contains12 suppositories
Medicaid pays$0.2138 / unit · 12 mo
Per package$2.57 / 12 suppository · Medicaid
Pack sizes2 compare ↓
Also comes in:
50 suppositories 71399-8460-05
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 →
🆔 Identity & classification
FDA NDC (as labeled)
71399-8460-2
Product NDC
71399-8460
11-digit billing NDC
71399846002
NCPDP billing unit
EA — each (per item)
RxCUI
198509
UNII
10X0709Y6I
UPC
0371399846020
Application #
M007
SPL Set ID
be4eeb4d-df29-45dc-94ff-933e52c8b6f6
Established class (EPC)
Stimulant Laxative
Physiologic effect
Increased Large Intestinal Motility; Stimulation Large Intestine Fluid/Electrolyte Secretion
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-09-13
Route
RECTAL
Dosage form
SUPPOSITORY
Substance
BISACODYL
GPI-14
46200010005205
GPI class
OneLAX
GCN Seq No
002944
GCN
08731
HICL code
001301
Ingredient (HICL)
Bisacodyl
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
ONELAX 10 MG SUPPOSITORY
FDB brand name
Onelax
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 71399-8460-2 — 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 → 71399-8460-02. 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.
🏷️ RxNorm drug class
This medicine belongs to the Stimulant Laxative class.
Pharmacologic class
Stimulant Laxative
Drug family (ATC)
Contact laxatives, Enemas
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerAKRON PHARMA INC
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code71399
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio15 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 ONELAX 10 MG SUPPOSITORY Ingredient Bisacodyl
📖 What it is MedlinePlus · NLM
Rectal bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- It depends on which form you're using. Oral tablets (like Dulcolax Stimulant Laxative) usually take 6 to 12 hours, so many people take them at bedtime and get results in the mornin...
- No — it's really important not to chew, crush, or break bisacodyl tablets. They have a special protective coating that helps them reach the right part of your gut without irritatin...
- Can I chew or crush the tablet if I have trouble swallowing?
- Milk and antacids can break down the protective coating on bisacodyl tablets too soon, before the medicine reaches where it needs to work. This can cause stomach irritation and mak...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Bisacodyl — tap one for details:
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.
💬 Questions about BISACODYL?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeOval
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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 8334LX7S21
A solid fat derived from animal or vegetable sources, used as a coating agent and lubricant to help pills slide smoothly during manufacturing and protect the medicine from moisture and air.
1 inactive ingredient listed in the exact product block matched to this NDC.
The official label also stateshydrogenated vegetable oil Manufactured for: Akron Pharma Inc., Fairfield, NJ-07004 www.akronpharma.com
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 system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.2138 | $2.57 / 12 suppository |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bisacodyl 10 mg 00574-7050-12 | Padagis | 12 suppositories | $0.321 | — | Availability likely | — |
| Bisacodyl 10 mg 00904-7142-12 | Major | 12 suppositories | $0.321 | — | Availability likely | — |
| Good Neighbor Pharmacy Gentle Laxative 10 mg/2000mg 46122-0608-51 | AmerisourceBergen | 40 mg | $0.321 | — | Availability likely | — |
| Bisacodyl 10 mg 57237-0327-03 | Rising | 30 suppositories | $0.321 | — | Availability likely | — |
| Proctozone-B 10 mg 57237-0337-03 | Rising | 30 suppositories | $0.321 | — | Availability likely | — |
| Bisacodyl 10 mg 70000-0573-01 | Cardinal | 4 suppositories | $0.321 | — | Availability likely | — |
| Foster and Thrive Gentle Laxative 10 mg/2000mg 70677-1091-01 | Strategic | 40 mg | $0.321 | — | Availability likely | — |
| Walgreens Gentle Laxative 10 mg 00363-0466-04 | Walgreens | 40 mg | — | — | FDA listed | — |
| Walgreens Gentle Laxative 10 mg 00363-0468-04 | Walgreens | 4 suppositories | — | — | FDA listed | — |
| Rite-Aid Gentle Laxative 10 mg 11822-4890-05 | RITE | 8 suppositories | — | — | FDA listed | — |
| Gentle Laxative Bisacodyl 10 mg 13709-0321-01 | NeilMed | 30 capsules | — | — | FDA listed | — |
| Bisacodyl Laxative 10 mg/1.8g 13709-0328-01 | Neilmed | 1.8 g | — | — | FDA listed | — |
| HEB Gentle Laxative 10 mg/2000mg 37808-0877-08 | H | 40 mg | — | — | FDA listed | — |
| Dulcolax Laxative 10 mg 41167-0210-01 | Chattem, | 4 suppositories | — | — | FDA listed | — |
| Meijer Gentle Laxative 10 mg/2000mg 41250-0665-04 | Meijer | 40 mg | — | — | FDA listed | — |
| Discount Drugmart Gentle Laxative 10 mg/2000mg 53943-0805-08 | Discount | 40 mg | — | — | FDA listed | — |
| Dollar General Gentle Laxative 10 mg/2000mg 55910-0457-04 | Dolgencorp, | 40 mg | — | — | FDA listed | — |
| Bisacodyl 10 mg 57896-0443-01 | GERI-CARE | 100 suppositories | — | — | FDA listed | — |
| Stratuscare Bisacodyl 10 mg 58980-0415-04 | Stratus | 4 suppositories | — | — | FDA listed | — |
| CVS Gentle Laxative 10 mg 59779-0107-09 | CVS | 8 suppositories | — | — | FDA listed | — |
| Bisacodyl 10 mg 68016-0084-08 | Pharmacy | 8 suppositories | — | — | FDA listed | — |
| Bisacodyl 10 mg 69842-0816-04 | CVS | 4 suppositories | — | — | FDA listed | — |
| Laxative 10 mg 70795-1010-01 | GRAXCELL | 100 suppositories | — | — | FDA listed | — |
| OneLAX 10 mgthis 71399-8460-02 | AKRON | 12 suppositories | — | — | FDA listed | — |
| Conlax 10 mg 72701-0102-04 | Bliss | 4 suppositories | — | — | FDA listed | — |
| Bisacodyl 10 mg 82568-0028-02 | AARNA | 12 suppositories | — | — | FDA listed | — |
| Bisacodyl 10 mg 83720-0550-25 | Oncor | 12 suppositories | — | — | FDA listed | — |
| Bisacodyl Laxative 10 mg 71457-0501-01 | InvaDerm | 102 suppositories | — | — | 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
🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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.
🗺️ 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 71399-8460-02, 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 – Q4 2025 · 2 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
122
Units reimbursed last 4 qtrs
2K
Gross reimbursed last 4 qtrs
$430.10
Avg / prescription
$3.53
Avg / unit
$0.2138
Latest quarter Q4 2025
62Rx
Fee-for-service vs managed care ⓘ
Fee-for-service · 0 Rx Managed care · 122 Rx
State Medicaid map
Units reimbursed · per 100k residents
35.135.1
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
💊 Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 122 Rx · 2,012 units · $430 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71399-8460-02 You're viewing this | 12 BLISTER PACK in 1 BOX (71399-8460-2) / 1 SUPPOSITORY in 1 BLISTER PACK | 2021-11-05 | Active |
| 71399-8460-05 | 50 BLISTER PACK in 1 BOX (71399-8460-5) / 1 SUPPOSITORY in 1 BLISTER PACK | 2021-11-05 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 71399-8460-02?
NDC 71399-8460-02 contains 12 suppositories — 12 blister pack in 1 box / 1 suppository in 1 blister pack.
What is the difference between NDC 71399-8460-02 and NDC 71399-8460-05?
Both are OneLAX BISACODYL 10 mg Suppository — the drug itself is identical. NDC 71399-8460-02 is the 12 suppositories package, while NDC 71399-8460-05 is the 50 suppositories package.
What NDC number is used to bill for this package of OneLAX BISACODYL 10 mg Suppository?
Bill NDC 71399-8460-02 — the 11-digit billing format is 71399846002. 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) | ✓ Available |
“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 71399-8460-2, 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: 71399-8460-02, written without dashes as 71399846002. 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 71399-8460-02, the first segment (71399) is the labeler code FDA assigned to AKRON PHARMA INC; the middle segment (8460) 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 AKRON PHARMA INC. 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 50 suppositories (71399-8460-05). 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?
AKRON PHARMA INC 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 ▾
Uses for relief of occasional constipation this product usually produces bowel movement in 1/4 to 1 hour
⏱️ Dosage and Administration ▾
Directions adults and children 12 years of age and older detach one suppository from the strip remove from wrapper before inserting into the rectum the rectal suppository dose is one suppository per day or as directed by a doctor children under 12 years of age consult a doctor
⚠️ Warnings ▾
Warnings For rectal use only.
🧪 Active Ingredient ▾
Active Ingredients (per suppository) Bisacodyl USP, 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredient hydrogenated vegetable oil Manufactured for: Akron Pharma Inc., Fairfield, NJ-07004 www.akronpharma.com
🎯 Purpose ▾
Purpose Laxative
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.