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Proctozone-G Glycerin 1.2 g Suppository, 12 suppositories — NDC 57237-0338-21 package photo

Proctozone-G Glycerin 1.2 g Suppository, 12 suppositories

by Rising Pharma Holdings, Inc. · 2 BLISTER PACK in 1 CARTON (57237-338-21) / 6 SUPPOSITORY in 1 BLISTER PACK (57237-338-16)
NDC 57237-0338-21
🏷️ FDA NDC (as labeled) 57237-338-21 billing pads the product segment with a zero
This package
Contains12 suppositories Cost per ea$0.1009 NADAC Per package$1.21 / 12 suppositories Pack sizes2 compare ↓
Also comes in: 25 suppositories 57237-0338-52
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

⚠️
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

FDA NDC (as labeled) 57237-338-21
Product NDC 57237-338
11-digit billing NDC 57237033821
NCPDP billing unit EA — each (per item)
RxCUI 421299
UNII PDC6A3C0OX
Application # M007.54
SPL Set ID 8a5c8ad5-3619-4971-967d-165270a20bc8
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 2025-07-31
Route RECTAL
Dosage form SUPPOSITORY
Substance GLYCERIN
GPI-14 46600010005209
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 CHILD PROCTOZONE-G 1.2 GM SUPP
FDB brand name Children's Proctozone-G
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 57237-338-21 — 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 → 57237-0338-21. 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.

🏭 Manufacturer & labeler

LabelerRising Pharma Holdings, Inc.
FDA applicationM007.54 (OTC MONOGRAPH DRUG)
Labeler code57237
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio525 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 CHILD PROCTOZONE-G 1.2 GM SUPP Ingredient Glycerin
🧪 What is this product?

Proctozone-G is a rectal suppository containing glycerin, an OTC monograph product. Glycerin is commonly used in suppositories to function as a lubricant and stool softener, typically helping to ease bowel movements. This product is meant to be inserted into the rectum.

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.

💊 What it looks like

Color white
ShapeBullet
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 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 statesInactive ingredients purified 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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.101 $1.21 / 12 suppositories
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.
NADAC price history (per ea) — tap or hover for the price & month
May 2026 Jun 2026 Jul 2026 Aug 2026 $0.113 $0.098
▼ Down 11% over the last 4 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glycerin 1.2 g 46122-0222-63 Amerisource 25 suppositories $0.101 — Availability likely —
Glycerin Children 1.2 g 57237-0326-21 Rising 12 suppositories $0.101 — Availability likely —
Proctozone-G 1.2 gthis 57237-0338-21 Rising 12 suppositories $0.101 — Availability likely —
Glycerin 1.2 g 52316-0724-25 DSC 25 suppositories — — FDA listed —
Bliss GVS Children 1.2 g 72701-0105-12 Bliss 12 suppositories — — FDA listed —
Glycerin 1.2 g 83324-0285-25 Chain 25 suppositories — — FDA listed —
Glycerin 1.2 g 84415-0041-50 Everpharm 50 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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 Proctozone-G (this brand).

Top reported reactions

Macular Degeneration598
Constipation440
Pain400
Nausea322
Pyrexia308
Malaise275
Weight Decreased268

Reporter sex

0 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization1,398
Death364
Life-threatening282
Disabling50
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 470 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 Per unit Per pack Marketing startStatus
57237-0338-21 You're viewing this 2 BLISTER PACK in 1 CARTON (57237-338-21) / 6 SUPPOSITORY in 1 BLISTER PACK (57237-338-16) $0.1009 / ea $1.21 2025-07-31 Active
57237-0338-52 5 BLISTER PACK in 1 CARTON (57237-338-52) / 5 SUPPOSITORY in 1 BLISTER PACK (57237-338-51) $0.1009 / ea $2.52 2025-07-31 Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1009 NADAC).

Pack size FAQ

What quantity is in NDC 57237-0338-21?
NDC 57237-0338-21 contains 12 suppositories — 2 blister pack in 1 carton / 6 suppository in 1 blister pack.
What is the difference between NDC 57237-0338-21 and NDC 57237-0338-52?
Both are Proctozone-G Glycerin 1.2 g Suppository — the drug itself is identical. NDC 57237-0338-21 is the 12 suppositories package, while NDC 57237-0338-52 is the 25 suppositories package.
What NDC number is used to bill for this package of Proctozone-G Glycerin 1.2 g Suppository?
Bill NDC 57237-0338-21 — the 11-digit billing format is 57237033821. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 17 words ▾

Uses For relief of occasional constipation This product usually produces bowel movement in 1/4 to 1 hour

⏱️ Dosage and Administration 120 words ▾

Directions Tear off one suppository from the strip If the suppository seems soft, place it in the refrigerator before use or run cold water over it before removing the foil wrapper Gently remove suppository by peeling apart the wrapper (see illustration 1) Rub a water-based lubricant over the tip or dip it in water. It will help you slide it in smoothly Lie on your side and insert 1 suppository, tapered end first, about the length of your finger into the rectum (see illustration 2) Hold the suppository for about 15-20 minutes to allow time for it to melt Children 2 to under 6 years of age ......................

1 suppository once daily Children under 2 years ............................................ ask a doctor

⚠️ Warnings 100 words ▾

Warnings For rectal use only Do not use for longer than 1 week unless directed by a doctor. Ask a doctor before use if the child has Stomach pain, nausea or vomiting A sudden change in bowel habits lasting more than 2 weeks When using this product your child may have rectal discomfort or a burning sensation Stop use and ask a doctor if you have Rectal bleeding No bowel movement after using this product These may indicate a serious condition. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 7 words ▾

Other Information Keep away from excessive heat.

🧪 Active Ingredient 9 words ▾

Active ingredient (in each suppository) Glycerin USP, 1.2 grams

🧪 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 ↗
← 57237-0337-03 · Rising 57237-0339-21 · Rising →
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.