Premieres Pain

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: Premieres Pain
Generic name: MENTHOL
Manufacturer: Premiere Enterprises
Product type: HUMAN OTC DRUG
SPL set ID: 1f081913-6106-4d06-a37a-631f710dbacb
SPL ID: 46a6f042-1931-0688-e063-6294a90ae162
Version: 6
Effective date: 2025-12-23
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:26:47

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Premieres Pain	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		Premiere Enterprises	openfda.manufacturer_name
ndc	package	32472-102-01	openfda.package_ndc
ndc	product	32472-102	openfda.product_ndc
ndc11	package	32472010201	derived:openfda.package_ndc
rxcui		1086713	openfda.rxcui
spl id		46a6f042-1931-0688-e063-6294a90ae162	id
spl set id		1f081913-6106-4d06-a37a-631f710dbacb	set_id
unii		L7T10EIP3A	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. Keep away from flame. Keep out of reach of children- if swallowed get medical help or contact a poison center right away. Avoid contact with eyes Do not apply to open wounds or damaged skin Do not bandage tightly Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Reported adverse events (FAERS/openFDA)#

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