Calamine Plus Pramoxine HCl

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: Calamine Plus Pramoxine HCl
Generic name: CALAMINE PLUS SPRAY
Manufacturer: Topco Associates LLC
Product type: HUMAN OTC DRUG
SPL set ID: af314adb-bd65-4233-b7e1-6cfb819615a3
SPL ID: 42f4abc5-8308-e7ed-e063-6394a90a748d
Version: 11
Effective date: 2025-11-06
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:15:40

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		Calamine Plus Pramoxine HCl	openfda.brand_name
generic name		CALAMINE PLUS SPRAY	openfda.generic_name
manufacturer name		Topco Associates LLC	openfda.manufacturer_name
ndc	package	36800-398-41	openfda.package_ndc
ndc	product	36800-398	openfda.product_ndc
ndc11	package	36800039841	derived:openfda.package_ndc
rxcui		1544717	openfda.rxcui
spl id		42f4abc5-8308-e7ed-e063-6394a90a748d	id
spl set id		af314adb-bd65-4233-b7e1-6cfb819615a3	set_id
unii		SOI2LOH54Z	openfda.unii
unii		1K09F3G675	openfda.unii
unii		88AYB867L5	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. Use only as directed. Intentional misuse by deliberately concentrating and inhailing contents can be harmful or fatal. When using this product do not get into eyes ask a doctor before using on children under 2 years of age Stop use and ask a doctor if conditions worsens symtomps last more than 7 days or clear up and occur again in a few days 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.