FDA.reportPublic FDA data

Proctozone-G

Manufacturer
Rising Pharma Holdings, Inc. | Bliss GVS Pharma Limited
Effective date
2026-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:33:17

Label at a glance#

ProductProctozone-G
Active ingredientGLYCERIN
Label structure12 sections

Storage and handling

Other Information Keep away from excessive heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each suppository)

Glycerin USP, 1.2 grams

OTC - PURPOSE SECTION

Purpose

Laxative

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For rectal use only

OTC - DO NOT USE SECTION

Do not use for longer than 1 week unless directed by a doctor.

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

When using this product your child may have rectal discomfort or a burning sensation

OTC - STOP USE SECTION

Stop use and ask a doctor if you have

  • Rectal bleeding
  • No bowel movement after using this product
    These may indicate a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Other Information

Keep away from excessive heat.

INACTIVE INGREDIENT SECTION

Inactive ingredients

purified water, sodium stearate.

OTC - QUESTIONS SECTION

Questions or Comments:

call 1-844-474-7464

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT, INDIVIDUALLY SEALED FOR YOUR PROTECTION

SPL UNCLASSIFIED SECTION

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Made in India

Code No.: MH/DRUGS/25-KD/724

Issued: 05/2025

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57237-338-21 (2 blisters of 6 suppositories)

Proctozone-GTM

GLYCERIN SUPPOSITORIES 1.2 g

RECTAL LAXATIVE

proctozone-G 1.2g 57237-338-21 fig-1proctozone-G 1.2g 57237-338-21 fig-1

proctozone-G 1.2g 57237-338-21 fig-2proctozone-G 1.2g 57237-338-21 fig-2

Front Foil (57237-338-16)

12005007 proctozone g 1.2 g front foil12005007 proctozone g 1.2 g front foil

Back Foil (57237-338-16)

12005006 proctozone g 1.2 g back foil12005006 proctozone g 1.2 g back foil

NDC 57237-338-52 (5 blisters of 5 suppositories)

13011263 proctozone g 1.2 g carton-2213011263 proctozone g 1.2 g carton-22


13011264 proctozone g 1.2 carton-113011264 proctozone g 1.2 carton-1

Front Foli (57237-338-51)

12005008 proctozone g front foil12005008 proctozone g front foil

Back Foil (57237-338-51)

12005012 proctozone g 1.2 g back foil12005012 proctozone g 1.2 g back foil

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
421299glycerin 1.2 GM Pediatric Rectal SuppositoryPSN2
421299glycerin 1200 MG Rectal SuppositorySCD2
421299glycerin 1.2 GM Rectal SuppositorySY2
421299glycerin 82.5 % Pediatric Rectal SuppositorySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-338-16Proctozone-G6 in 1 BLISTER PACKSUPPOSITORY62
57237-338-21Proctozone-G2 in 1 CARTONSUPPOSITORY22
57237-338-51Proctozone-G5 in 1 BLISTER PACKSUPPOSITORY52
57237-338-52Proctozone-G5 in 1 CARTONSUPPOSITORY52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-338-21EA - Each57237-338d9975424-28d8-4056-bba0-12a65ba68c4912026-03-17
57237-338-52EA - Each57237-33852363b9a-647e-4086-b413-4bb3dada1f9712026-03-17

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-33857237-338-16, 57237-338-21, 57237-338-51, 57237-338-52

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM STEARATEQU7E2XA9TGIACT
GLYCERINPDC6A3C0OXACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proctozone-GGLYCERINRising Pharma Holdings, Inc.8a5c8ad5-3619-4971-967d-165270a20bc82026-01-06WarningsExact identifier
ndc (package): 57237-338-51
ndc (package): 57237-338-52
ndc (package): 57237-338-21
ndc (package): 57237-338-16
ndc (product): 57237-338
ndc11 (package): 57237033852
ndc11 (package): 57237033816
ndc11 (package): 57237033821
ndc11 (package): 57237033851
spl id: 553c8839-ee7f-4b94-986f-69ddfbf085c5
spl set id: 8a5c8ad5-3619-4971-967d-165270a20bc8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.