FDA.reportPublic FDA data

BiteMD - Wisconsin Pharmacal Company

Manufacturer
Wisconsin Pharmacal Company
Effective date
2026-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:54:13

Label at a glance#

ProductBiteMD
Active ingredientPHENOL, CAMPHOR (SYNTHETIC), BENZOCAINE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ASK DOCTOR SECTION

Ask Doctor SectionAsk Doctor Section

OTC - DO NOT USE SECTION

Do not use sectionDo not use section

WARNINGS SECTION

Warnings sectionWarnings section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children sectionKeep out of reach of children section

INSTRUCTIONS FOR USE SECTION

Instructions for use sectionInstructions for use section

STORAGE AND HANDLING SECTION

Storage and handling sectionStorage and handling section

DOSAGE & ADMINISTRATION SECTION

Dosage and administration sectionDosage and administration section

INACTIVE INGREDIENT SECTION

inactive ingredient sectioninactive ingredient section

OTC - QUESTIONS SECTION

Questions sectionQuestions section

INDICATIONS & USAGE SECTION

indications and usage sectionindications and usage section

OTC - PURPOSE SECTION

purpose sectionpurpose section

OTC - ACTIVE INGREDIENT SECTION

active ingredientsactive ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package labelPackage labelPackage labelPackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1435257benzocaine 5 % / camphor 3 % / phenol 1.35 % Topical SolutionPSN1
1435257benzocaine 50 MG/ML / camphor 30 MG/ML / phenol 13.5 MG/ML Topical SolutionSCD1
1435257benzocaine 5 % / camphor 3 % / phenol 1.35 % Topical SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68093-9561-1BiteMD14.7 mL in 1 VIAL, PLASTICLIQUID14.71
68093-9561-2BiteMD1 in 1 BLISTER PACKLIQUID11

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68093-956168093-9561-1, 68093-9561-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOL339NCG44TVACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML

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
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
ndc (package): 68093-9561-1
ndc (package): 68093-9561-2
ndc (product): 68093-9561
ndc11 (package): 68093956102
ndc11 (package): 68093956101
spl id: 4f860c1e-a639-4923-e063-6294a90ae7e2
spl set id: 4f860c1e-a638-4923-e063-6294a90ae7e2

Reported adverse events (FAERS/openFDA)#

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