PM Toothache Relief

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: PM Toothache Relief
Generic name: BENZOCAINE
Manufacturer: CVS
Product type: HUMAN OTC DRUG
SPL set ID: 0a5a8cd0-d680-8a0f-e063-6294a90aa65c
SPL ID: 439566da-cc7b-d5bc-e063-6394a90a6b64
Version: 4
Effective date: 2025-11-14
Source export date: 2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:07:34

Harmonized routes table
Harmonized routes
DENTAL

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		PM Toothache Relief	openfda.brand_name
generic name		BENZOCAINE	openfda.generic_name
manufacturer name		CVS	openfda.manufacturer_name
ndc	package	69842-623-09	openfda.package_ndc
ndc	product	69842-623	openfda.product_ndc
ndc11	package	69842062309	derived:openfda.package_ndc
rxcui		2370903	openfda.rxcui
spl id		439566da-cc7b-d5bc-e063-6394a90a6b64	id
spl set id		0a5a8cd0-d680-8a0f-e063-6294a90aa65c	set_id
unii		U3RSY48JW5	openfda.unii
unii		L7T10EIP3A	openfda.unii
unii		F5UM2KM3W7	openfda.unii
unii		86Q357L16B	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

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition tha tmust be treated promptly becuase it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy.

Reported adverse events (FAERS/openFDA)#

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