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Stratuscare Glycerin Laxative Pediatric 1 g Suppository, 12 suppositories — NDC 58980-0409-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Stratuscare Glycerin Laxative Pediatric 1 g Suppository, 12 suppositories — NDC 58980-409-12 (Billing 58980-0409-12)

by Stratus Pharmaceuticals · 12 SUPPOSITORY in 1 JAR

This is a package of 12 suppositories of Stratuscare Glycerin Laxative Pediatric 1 g Suppository from Stratus Pharmaceuticals, marketed since Jun 2014 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 58980-0409-12
🏷️ FDA NDC (as labeled) 58980-409-12 billing pads the product segment with a zero
This package
Contains12 suppositories Pack sizes2 compare ↓
Main listing for product 58980-409 · Also comes in: 25 suppositories 58980-409-25
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

⚠️
Other active recalls for Glycerin (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 27, 2026 — Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. (Oasis Medical, Inc.) · FDA recall D-0525-2026
Class II · Apr 20, 2026 — Lack of Assurance of Sterility (SCOPE HEALTH) · FDA recall D-0499-2026
Class II · Mar 25, 2026 — Lack of Assurance of Sterility (Preferred Pharmaceuticals, Inc.) · FDA recall D-0443-2026
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0411-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58980-409-12
Product NDC 58980-409
11-digit billing NDC 58980040912
NCPDP billing unit EA — each (per item)
RxCUI 252062
UNII PDC6A3C0OX
Application # M007
SPL Set ID 6ae6d3c4-bb3b-4436-b76d-8654bf871e66
Established class (EPC) Non-Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Allergens; Glycerol
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-06-01
Route RECTAL
Dosage form SUPPOSITORY
Substance GLYCERIN

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

GPI-14 46600010005206
GPI class Glycerin (Infants & Children)
GCN Seq No 011729
GCN 08861
HICL code 001312
Ingredient (HICL) Glycerin
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 GLYCERIN PEDIATRIC SUPPOSITORY
FDB brand name Glycerin
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 011729
  • GCN: 08861
  • GPI-14 (Medi-Span): 46600010005206
  • HICL (First Databank): 001312
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 252062
Why two NDCs? The FDA registers this code as 58980-409-12 — 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 → 58980-0409-12. 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.

RxNorm drug class

This medicine belongs to the Non-Standardized Chemical Allergen class.

Pharmacologic class Non-Standardized Chemical Allergen
Drug family (ATC) Enemas, Other drugs for constipation
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.

Clinical

Label name GLYCERIN PEDIATRIC SUPPOSITORY Ingredient Glycerin
🧪 What is this product?

This is an over-the-counter rectal suppository containing glycerin, marketed under FDA's OTC monograph rules for laxative products. Glycerin is commonly used as a stool softener and mild laxative, functioning by drawing water into the intestines to help ease bowel movements. The pediatric formulation delivers 1 gram of glycerin per suppository for rectal use. This product type is typically used to provide occasional relief from constipation.

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 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: 25 suppositories
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
58980-0409-12 You're viewing this Main listing 12 SUPPOSITORY in 1 JAR 2014-06-01 — Active
58980-0409-25 58980-409-25 25 SUPPOSITORY in 1 JAR 2014-06-01 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 12 suppositories — 12 suppository in 1 jar.
How does this package differ from NDC 58980-0409-25?
Both are Stratuscare Glycerin Laxative Pediatric 1 g Suppository — the drug itself is identical. This page's package is the 12 suppositories one, while NDC 58980-0409-25 is the 25 suppositories package.
What NDC number is used to bill for this package of Stratuscare Glycerin Laxative Pediatric 1 g 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glycerin 1 g 70000-0429-01 Cardinal 25 suppositories $0.122 — Availability likely —
Glycerin 1 g 11822-3321-08 Rite 25 suppositories — — FDA listed —
Rite-Aid Childrens Glycerin Laxative 1 g 11822-9101-02 RITE 25 suppositories — — FDA listed —
Glycerin 1 g/1.25g 13709-0333-01 Neilmed 1.2 g — — FDA listed —
Glycerin 1 g 37808-0399-25 H 25 suppositories — — FDA listed —
Stratuscare Glycerin Laxative Pediatric 1 gthis 58980-0409-12 Stratus 12 suppositories — — FDA listed —
Glycerin 1 g 68016-0161-00 Chain 25 suppositories — — FDA listed —
Glycerin 1 g/1.21 69842-0722-25 CVS 25 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

🏛️
2014
On the market since
Jun 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.

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 QU7E2XA9TG
    Sodium stearate is a salt derived from stearic acid, a natural fatty substance. It acts as a lubricant and binder in tablets and capsules, helping the medicine hold together and flow smoothly during manufacturing.
  • 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.

2 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statespurified water, sodium stearate

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

LabelerStratus Pharmaceuticals
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code58980
First marketedJun 2014
Product typeHuman Otc Drug
Portfolio4 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
🎯 Indications and Usage 16 words ▾

Use For relief of occasional constipation (irregularity) generally produces bowel movement in ¼ to 1 hour.

⏱️ Dosage and Administration 55 words ▾

Directions Children 2 to under 6 years of age: Carefully insert one suppository well into child's rectum It need not melt completely to produce laxative action Generally produces bowel movement in 15 minutes to 1 hour Do not exceed one suppository daily unless directed by a doctor Children under 2 years old: Consult a doctor.

⚠️ Warnings 101 words ▾

Warnings For rectal use only. May cause rectal discomfort or burning sensation. Ask a doctor before use if your child has: abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks.

Stop use and ask a doctor: if your child has rectal bleeding or fails to have a bowel movement after using a laxative. This may indicate a serious condition. Do not use laxative products for longer than 1 week unless directed by a doctor Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).

📦 Storage and Handling 16 words ▾

Other information Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F)

🧪 Active Ingredient 7 words ▾

Active ingredient (per suppository) Glycerin, USP 1g

🧪 Inactive Ingredients 6 words ▾

Inactive ingredients purified water, sodium stearate

🎯 Purpose 2 words ▾

Purpose Laxative

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

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 1 other package presentation of this same product, including 25 suppositories (58980-0409-25). 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.
← 58980-0012-01 · STRATUS 58980-0410-12 · Stratus →
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.