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: FSA Store Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 3cd18f96-34f7-3f2c-e063-6294a90a3b7e
SPL ID: 3cd1933c-6340-50d6-e063-6294a90aca32
Version: 1
Effective date: 2025-08-19
Source export date: 2026-10-27
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/eeb012fd0992efa4f76b2aef09dd5f84150b96392c46717c44deabcc4e3581c1/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:39:15

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		FSA Store Inc.	openfda.manufacturer_name
ndc	package	81522-959-01	openfda.package_ndc
ndc	product	81522-959	openfda.product_ndc
ndc11	package	81522095901	derived:openfda.package_ndc
rxcui		1544717	openfda.rxcui
spl id		3cd1933c-6340-50d6-e063-6294a90aca32	id
spl set id		3cd18f96-34f7-3f2c-e063-6294a90a3b7e	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 symptoms 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.