CALMADOL

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: CALMADOL
Generic name: CAMPHOR, MENTHOL, METHYL SALICYLATE
Manufacturer: GRANDALL DISTRIBUTING, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 31b7f84e-8b66-4d31-8e9c-279d0af2fe64
SPL ID: 42406bd7-6d6c-1f54-e063-6394a90a023e
Version: 11
Effective date: 2025-10-28
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:18:43

Harmonized routes table
Harmonized routes
TOPICAL

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		CALMADOL	openfda.brand_name
generic name		CAMPHOR, MENTHOL, METHYL SALICYLATE	openfda.generic_name
manufacturer name		GRANDALL DISTRIBUTING, LLC	openfda.manufacturer_name
ndc	package	48201-004-17	openfda.package_ndc
ndc	product	48201-004	openfda.product_ndc
ndc11	package	48201000417	derived:openfda.package_ndc
rxcui		2688458	openfda.rxcui
spl id		42406bd7-6d6c-1f54-e063-6394a90a023e	id
spl set id		31b7f84e-8b66-4d31-8e9c-279d0af2fe64	set_id
unii		L7T10EIP3A	openfda.unii
unii		N20HL7Q941	openfda.unii
unii		LAV5U5022Y	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 external use only When using this product Avoid contact with eyes and mucous membranes Do not bandage tightly Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within few days. If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use. Keep out of reach of childern. If swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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