Calmol 4

Manufacturer: Resical Inc. | DSC Laboratories Inc.
Effective date: 2025-10-24
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 01:40:11

Label at a glance#

ProductCalmol 4

Active ingredientZINC OXIDE, COCOA BUTTER

Label structure9 sections

Indications and uses

gives temporary relief of burning, irritation, itching and discomfort associated with hemorrhoids temporarily provides a coating for for anorectal discomforts temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and administration

adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product detach one suppository from the strip; remove wrapper before inserting into rectum as follows: slowly peel down film wrapper by pulling evenly and slowly on tabs to expose suppository insert 1 suppository b...

Contacts and useful links#

PhoneLabel contact1-800-204-6434

Label contents#

Full prescribing information#

Active Ingredients (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Cocoa Butter 76%

Zinc Oxide 10%

Purpose

OTC - PURPOSE SECTION

Protectant

Astringent

Uses

INDICATIONS & USAGE SECTION

gives temporary relief of burning, irritation, itching and discomfort associated with hemorrhoids
temporarily provides a coating for for anorectal discomforts
temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

WARNINGS SECTION

For rectal use only

When using this product

OTC - WHEN USING SECTION

do not exceed the recommended daily dosage unless directed by a doctor

Stop use and ask doctor if

OTC - STOP USE SECTION

bleeding occurs or if condition worsens or does not improve within 7 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad
gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
detach one suppository from the strip; remove wrapper before inserting into rectum as follows:
- slowly peel down film wrapper by pulling evenly and slowly on tabs to expose suppository
insert 1 suppository bulb shape first into the rectum up to 6 times daily or after each bowl movement
children under 12 years of age, consult a doctor

Other information

OTHER SAFETY INFORMATION

store in a cool place not ober 80°F to avoid melting
if subjected to higher temperatures, refrigeration may restore to a usable condition

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bismuth subgallate, glyceryl stearate, hydrogenated vegetable oil, methylparaben, propylparaben

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-204-6434 weekdays 9 AM to 5 PM EST

Calmol 4 Suppository 24 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALMOL 24ct_R0625.p1.pdf

Calmol 4 Hemorrhoidal Suppository

24 count

Distributed by: Resical Inc.

Orchard Park, New York 14127

The image below depicts a representative sample of packaging that is available.

CALMOL 24CT_R0625.p1.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1113714	Calmol 4, 76 % / 10 % Rectal Suppository	PSN	12
1049137	cocoa butter 76 % / zinc oxide 10 % Rectal Suppository	PSN	12
1113714	cocoa butter 0.76 MG/MG / zinc oxide 0.1 MG/MG Rectal Suppository [Calmol]	SBD	12
1049137	cocoa butter 0.76 MG/MG / zinc oxide 0.1 MG/MG Rectal Suppository	SCD	12
1113714	Calmol-4 (cocoa butter 76 % / zinc oxide 10 % ) Rectal Suppository	SY	12
1049137	cocoa butter 0.76 MG/MG / ZNO 0.1 MG/MG Rectal Suppository	SY	12
1113714	cocoa butter 0.76 MG/MG / ZNO 0.1 MG/MG Rectal Suppository [Calmol]	SY	12
1049137	cocoa butter 76 % / zinc oxide 10 % Rectal Suppository	SY	12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67492-104-11	Calmol 4	6 in 1 BLISTER PACK	SUPPOSITORY	6	12
67492-104-11	Calmol 4	4 in 1 CARTON	SUPPOSITORY	4	12
67492-104-12	Calmol 4	2 in 1 CARTON	SUPPOSITORY	2	12
67492-104-12	Calmol 4	6 in 1 BLISTER PACK	SUPPOSITORY	6	12
67492-104-13	Calmol 4	2 in 1 BLISTER PACK	SUPPOSITORY	2	12
67492-104-13	Calmol 4	1 in 1 CARTON	SUPPOSITORY	1	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67492-104-11	EA - Each	67492-104	276af734-d50d-48c9-a09c-796616e12510	1	2021-07-15
67492-104-12	EA - Each	67492-104	4809ba74-b618-4043-9e90-e1431c926a27	1	2021-07-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
COCOA BUTTER	ACTIVE INGREDIENT	512OYT1CRR	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	1
BISMUTH SUBGALLATE	INACTIVE INGREDIENT	YIW503MI7V	1
FAT, HARD	INACTIVE INGREDIENT	8334LX7S21	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Calmol 4
Zinc Oxide and Cocoa Butter
GLYCERYL MONOSTEARATE
FAT, HARD
METHYLPARABEN
PROPYLPARABEN
ZINC OXIDE
COCOA BUTTER
BISMUTH SUBGALLATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67492-104	67492-104-11, 67492-104-12, 67492-104-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
FAT, HARD	8334LX7S21	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB
COCOA BUTTER	512OYT1CRR	ACTIB
BISMUTH SUBGALLATE	YIW503MI7V	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
11	2024-12-12	full-release	2026-06-01 00:43:13

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii+route 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii+dosage form 16 equally ranked IID candidates
FAT, HARD	HARD FAT	8334LX7S21	SUPPOSITORY / RECTAL		7657 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii+route 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii+dosage form 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii+route 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
FAT, HARD	HARD FAT	8334LX7S21	SUPPOSITORY / RECTAL		7657 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii+dosage form 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii+route 16 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii+dosage form 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii+route 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii+route 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii+route 16 equally ranked IID candidates
FAT, HARD	HARD FAT	8334LX7S21	SUPPOSITORY / RECTAL		7657 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii+dosage form 16 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii+dosage form 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii+dosage form 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii+route 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii+dosage form 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii+route 16 equally ranked IID candidates
FAT, HARD	HARD FAT	8334LX7S21	SUPPOSITORY / RECTAL		7657 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calmol 4	ZINC OXIDE AND COCOA BUTTER	Resical Inc.	5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	2025-10-24	Warnings	Exact identifier ndc (package): 67492-104-13 ndc (package): 67492-104-12 ndc (package): 67492-104-11 ndc (product): 67492-104 ndc11 (package): 67492010413 ndc11 (package): 67492010411 ndc11 (package): 67492010412 spl id: 41eb9348-e861-4ac7-e063-6294a90a96cf spl set id: 5516f800-d3fa-4b90-a3eb-c0bdf3183b9b

Reported adverse events (FAERS/openFDA)#

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