5820623 Walgreens Nightime 4X Medicated Cream (8015623)

Manufacturer
Walgreens | Lornamead Products
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:16:16

Label at a glance#

ProductPM Toothache Relief
Active ingredientBENZOCAINE, MENTHOL, ZINC CHLORIDE, BENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

For the temporary relief of pain due to toothaches. To help protect aganist infection of minor oral irritation.

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, chamomile, flavor, mineral oil, PEG-8, PEG-77, sodium saccharin, sorbic acid, titanium dioxide

INDICATIONS & USAGE SECTION

Cut open tip of tube on score mark. Adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product. Children under 2 years of age: do not use.

OTC - ACTIVE INGREDIENT SECTION

Belzalkomium Chloride 0.13% Oral antiseptic

Benzocaine 20% Oral pain releiver

Methol 0.26% Oral pain releiver

Zinc chloride 0.15% Oral astringent

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a POison Control Center right away.

OTC - PURPOSE SECTION

Do not nuse if tube tip is cust prior to opening. This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously . This formula will stay in place for extended duration of relief. Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying.

WARNINGS SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20% benzocaine to releive oral pain

Kills harmful bacteria

Astringent to help prevent infection

Cools gums and relieves irritation

Net Wt 0.25 oz (7g)

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamPSN6
2370903benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral CreamSCD6
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1623-09PM Toothache Relief7.1 g in 1 TUBEPASTE7.16
0363-1623-09PM Toothache Relief1 in 1 BOXPASTE16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-16230363-1623-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-08-12legacy-cache2026-10-22 17:44:44

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PM Toothache ReliefBENZOCAINEWalgreense816f742-fba9-3c12-e053-2a95a90a192f2025-11-14WarningsExact identifier
ndc (package): 0363-1623-09
ndc (product): 0363-1623
ndc11 (package): 00363162309
spl id: 43956f49-90bc-5b18-e063-6294a90aad71
spl set id: e816f742-fba9-3c12-e053-2a95a90a192f

Reported adverse events (FAERS/openFDA)#

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