Calmol 4

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Calmol 4
Generic name: ZINC OXIDE AND COCOA BUTTER
Manufacturer: Resical Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 5516f800-d3fa-4b90-a3eb-c0bdf3183b9b
SPL ID: 41eb9348-e861-4ac7-e063-6294a90a96cf
Version: 12
Effective date: 2025-10-24
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:26:33

Harmonized routes table
Harmonized routes
RECTAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M015	openfda.application_number
brand name		Calmol 4	openfda.brand_name
generic name		ZINC OXIDE AND COCOA BUTTER	openfda.generic_name
manufacturer name		Resical Inc.	openfda.manufacturer_name
ndc	package	67492-104-13	openfda.package_ndc
ndc	package	67492-104-12	openfda.package_ndc
ndc	package	67492-104-11	openfda.package_ndc
ndc	product	67492-104	openfda.product_ndc
ndc11	package	67492010413	derived:openfda.package_ndc
ndc11	package	67492010411	derived:openfda.package_ndc
ndc11	package	67492010412	derived:openfda.package_ndc
rxcui		1049137	openfda.rxcui
rxcui		1113714	openfda.rxcui
spl id		41eb9348-e861-4ac7-e063-6294a90a96cf	id
spl set id		5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	set_id
unii		512OYT1CRR	openfda.unii
unii		SOI2LOH54Z	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For rectal use only When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask doctor if bleeding occurs or if condition worsens or does not improve within 7 days 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.

Reported adverse events (FAERS/openFDA)#

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