Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Stratuscare Bisacodyl 10 mg Suppository, 12 suppositories — NDC 58980-415-12 (Billing 58980-0415-12)
by Stratus Pharmaceuticals · 12 SUPPOSITORY in 1 BOX
This is a package of 12 suppositories of Stratuscare Bisacodyl 10 mg Suppository from Stratus Pharmaceuticals, marketed since May 2014 and currently FDA-listed.
NDC 58980-0415-12
🏷️ FDA NDC (as labeled)
58980-415-12
billing pads the product segment with a zero
This package
Contains12 suppositories
Pack sizes5 compare ↓
Product page 58980-0415-04
Also comes in:
4 suppositories 58980-415-04
8 suppositories 58980-415-08
16 suppositories 58980-415-16
50 suppositories 58980-415-50
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
58980-415-12
Product NDC
58980-415
11-digit billing NDC
58980041512
NCPDP billing unit
EA — each (per item)
RxCUI
198509
UNII
10X0709Y6I
Application #
M007
SPL Set ID
795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d
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
2014-05-30
Route
RECTAL
Dosage form
SUPPOSITORY
Substance
BISACODYL
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
46200010005205
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
GENTLE LAXATIVE 10 MG SUPPOSIT
FDB brand name
Gentle Laxative
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 002944
- GCN: 08731
- GPI-14 (Medi-Span): 46200010005205
- HICL (First Databank): 001301
- AHFS class code: 56:12.00.00
- RxCUI (RxNorm): 198509
Why two NDCs?
The FDA registers this code as 58980-415-12 — 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 → 58980-0415-12. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name GENTLE LAXATIVE 10 MG SUPPOSIT Ingredient Bisacodyl
📗 Our plain-language guide HelloPharmacist
- It relieves occasional constipation and irregularity. The Fleet enema is also used for fecal impaction and to clear residue after a barium test. It is meant for short-term use.
- It depends on the form. Tablets usually work in 6 to 12 hours. Suppositories usually work in 15 minutes to 1 hour. The Fleet enema usually works in 5 to 20 minutes.
- Not right away. Wait at least 1 hour after an antacid or milk before taking tablets. Swallow tablets whole with water and do not chew or crush them.
- Can I take the tablets with an antacid or milk?
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Bisacodyl?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 | 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 58980-0415-04 58980-415-04 Main listing | 4 SUPPOSITORY in 1 BOX | 2014-05-30 | — | Active |
| 58980-0415-08 58980-415-08 | 8 SUPPOSITORY in 1 BOX | 2014-05-30 | — | Active |
| 58980-0415-12 You're viewing this | 12 SUPPOSITORY in 1 BOX | 2014-05-30 | — | Active |
| 58980-0415-16 58980-415-16 | 16 BLISTER PACK in 1 BOX / 1 SUPPOSITORY in 1 BLISTER PACK | 2025-05-01 | — | Active |
| 58980-0415-50 58980-415-50 | 50 BLISTER PACK in 1 BOX / 1 SUPPOSITORY in 1 BLISTER PACK | 2020-06-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This package contains 12 suppositories — 12 suppository in 1 box.
How does this package differ from NDC 58980-0415-04?
Both are Stratuscare Bisacodyl 10 mg Suppository — the drug itself is identical. This page's package is the 12 suppositories one, while NDC 58980-0415-04 is the 4 suppositories package.
What NDC number is used to bill for this package of Stratuscare Bisacodyl 10 mg Suppository?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bisacodyl 10 mg 00574-7050-12 | Padagis | 12 suppositories | $0.320 | — | Availability likely | — |
| Bisacodyl 10 mg 00904-7142-12 | Major | 12 suppositories | $0.320 | — | Availability likely | — |
| Good Neighbor Pharmacy Gentle Laxative 10 mg/2000mg 46122-0608-51 | AmerisourceBergen | 40 mg | $0.320 | — | Availability likely | — |
| Bisacodyl 10 mg 57237-0327-03 | Rising | 30 suppositories | $0.320 | — | Availability likely | — |
| Proctozone-B 10 mg 57237-0337-03 | Rising | 30 suppositories | $0.320 | — | Availability likely | — |
| Bisacodyl 10 mg 70000-0573-01 | Cardinal | 4 suppositories | $0.320 | — | Availability likely | — |
| Foster and Thrive Gentle Laxative 10 mg/2000mg 70677-1091-01 | Strategic | 40 mg | $0.320 | — | 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 mgthis 58980-0415-12 | Stratus | 12 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 mg 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2014
On the market since
May 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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
White
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.
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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 A2M91M918C
A plant-based oil derived from soybeans that has been chemically hardened to make it solid or semi-solid at room temperature. It acts as a binder, filler, and lubricant to help hold the tablet together and allow it to move smoothly during manufacturing and packaging.
1 inactive ingredient listed in the exact product block matched to this NDC.
The official label also statesHydrogenated Vegetable Oil
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerStratus Pharmaceuticals
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code58980
First marketedMay 2014
Product typeHuman Otc Drug
Portfolio5 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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 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 ▾
Uses for relief of occasional constipation and irregularity this product generally produces bowel movement in 15 minutes to 1 hour
⏱️ Dosage and Administration ▾
Directions Adults and children 12 years of age and older Children 6 to under 12 years Children under 6 One suppository once daily 1/2 suppository once daily Ask a doctor Detach one suppository from the strip and remove from foil Carefully insert well into rectum Do not use more than once per day
⚠️ Warnings ▾
Warning for rectal use only Do not use more than once per day for a period of longer than one week unless directed by a doctor laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor Ask a doctor before use if you have noticed a sudden change in bowel habits that persist over a period of two weeks When using this product you may have abdominal discomfort, faintness, rectal burning and mild cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative because this 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 ▾
Other information Store at 15°C to 30°C (59°F to 86°F). Do not exceed 30°C (86°F). Individually sealed for your protection. Do not use if foil is torn or open.
🧪 Active Ingredient ▾
Active ingredient (in each suppository) Bisacodyl 10mg
🧪 Inactive Ingredients ▾
Inactive ingredients Hydrogenated Vegetable Oil
🎯 Purpose ▾
Purpose Stimulative laxative
📄 Do Not Use ▾
Do not use more than once per day for a period of longer than one week unless directed by a doctor laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have noticed a sudden change in bowel habits that persist over a period of two weeks
📄 When Using This Product ▾
When using this product you may have abdominal discomfort, faintness, rectal burning and mild cramps
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative because this may indicate a serious condition.
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions or comments? 1-800-442-7881
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Box STRATUSCARE 12 Suppositories Comfort Shaped Distributed by: STRATUS PHARMACEUTICALS INC NDC 58980-415-12 Gentle Laxative (BISACODYL USP 10 mg) Stimulant laxative Gentle yet effective WORKS IN 15 MINUTES TO 1 HOUR Compare to the active ingredient in Dulcolax ® * PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Box
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 ↗
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 Bisacodyl — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 43%
Female · 57%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Stratus Pharmaceuticals. 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 4 other package presentations of this same product, including 4 suppositories (58980-0415-04), 8 suppositories (58980-0415-08), 16 suppositories (58980-0415-16). 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?
Stratus Pharmaceuticals 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.
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.