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: Premier Brands of America, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: d3452573-f91f-f157-e053-2a95a90a1ad8
SPL ID: 4229a38a-85a1-4153-e063-6294a90a7971
Version: 6
Effective date: 2025-10-27
Source export date: 2026-10-30
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/2026-10-30/e1583c3c823c7746dc6fefae78ac97d01bb558f7b0936fc3b7d2e673d3319207/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:35:49

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 · 12 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		Premier Brands of America, Inc.	openfda.manufacturer_name
ndc	package	56104-251-00	openfda.package_ndc
ndc	product	56104-251	openfda.product_ndc
ndc11	package	56104025100	derived:openfda.package_ndc
spl id		4229a38a-85a1-4153-e063-6294a90a7971	id
spl set id		d3452573-f91f-f157-e053-2a95a90a1ad8	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. Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhaling 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.