FDA.reportPublic FDA data

Bactimicina Lozenge

Manufacturer
DLC Laboratories, Inc. | Lozen Pharma Private Limited
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-09 01:01:29

Label at a glance#

ProductBactimicina for Sore Throat
Active ingredientBENZOCAINE
Label structure10 sections

Dosage and administration

adults and children 5 years of age and older: Dissolve 1 lozenge slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: do not use.

Storage and handling

protect from moisture store at room temperature check expiration date before using

Label contents#

Full prescribing information#

Active Ingredient (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 15 mg

Purpose

OTC - PURPOSE SECTION

Oral anesthetic/Analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieve:

  • occational minor irritation, pain, sore mouth and sore throat

Warnings

WARNINGS SECTION

Methemoglobinemia warning:

SPL UNCLASSIFIED SECTION

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because 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 developes:

  • pale, gray, or blue colored skin (cyanosis)
  • shortness of breath
  • headache
  • dizziness or lightheadedness
  • rapid heart rate
  • fatigue or lack of energy

Allergy Alert

SPL UNCLASSIFIED SECTION

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or any other "caine" anesthetics. If skin reation occurs, stop use and seek medical help right away.

Sore throat warning:

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • for teething
  • in children under 5 years of age

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, or if more than used for pain relief is accidentally swallowed, get medical help or contact a Poison COntrol Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 5 years of age and older:

Dissolve 1 lozenge slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist.

  • children under 5 years of age: do not use.

Other information

STORAGE AND HANDLING SECTION

  • protect from moisture
  • store at room temperature
  • check expiration date before using

Inactive Ingredients

INACTIVE INGREDIENT SECTION

sucrose, liquid glucose, propylene glycol, natural orange flavor, artificial orange flavor, FD&C red #40, FD&C yellow #6,

Question

OTC - QUESTIONS SECTION

1-800-858-3889

SPL UNCLASSIFIED SECTION

Distributed by

De La Cruz Products

A Division of DLC Laboratories, Inc.

Paramount, CA 90723 USA

Principle Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fast Acting

Trusted since 1978

Maximum Strength

Bactimicina ®

Sore Throat Pain Relief

Benzocain Oral Anesthetic

Orange Flavor

18 Lozenges

Bactimicina Lozenge1Bactimicina Lozenge1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24286-1577-12024-01-30C16284748780-10191ceaa-6b99-198a-e063-dbdaa90aec3eBactimicina Lozenge
24286-1577-12024-01-30C16284748780-10191ceaa-6b99-198a-e063-dbdaa90aec3eBactimicina Lozenge
24286-1577-12024-01-30C16284748780-10191ceaa-6b99-198a-e063-dbdaa90aec3eBactimicina Lozenge
24286-1577-12023-08-14C16284748780-10191ceaa-6b99-198a-e063-dbdaa90aec3eBactimicina Lozenge
24286-1577-12023-08-14C16284748780-10191ceaa-6b99-198a-e063-dbdaa90aec3eBactimicina Lozenge
24286-1577-12023-08-14C16284748780-10191ceaa-6b99-198a-e063-dbdaa90aec3eBactimicina Lozenge
24286-1577-12023-07-28C16284748780-10191ceaa-6b99-198a-e063-dbdaa90aec3eBactimicina Lozenge
24286-1577-12023-07-28C16284748780-10191ceaa-6b99-198a-e063-dbdaa90aec3eBactimicina Lozenge
24286-1577-12023-07-28C16284748780-10191ceaa-6b99-198a-e063-dbdaa90aec3eBactimicina Lozenge

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24286-157724286-1577-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
BUTYRIC ACID40UIR9Q29HIACT
CAPRYLALDEHYDEXGE9999H19IACT
ORANGE OIL, DISTILLEDH4QNH2ZN7AIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
CITRONELLALQB99VZZ7GZIACT
LINALOOLD81QY6I88EIACT
ACETALDEHYDEGO1N1ZPR3BIACT
ACETIC ACIDQ40Q9N063PIACT
TOCOPHEROLR0ZB2556P8IACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCROSEC151H8M554IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
DECANAL31Z90Q7KQJIACT
CITRALT7EU0O9VPPIACT
LAURYL ALDEHYDEC42O120SEFIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-08-11daily-update2026-10-06 02:02:12
22024-07-10full-release2026-06-01 00:15:04

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
Bactimicina for Sore ThroatBENZOCAINEDLC Laboratories, Inc.d3abce13-cc87-e661-e053-2a95a90a1b7c2024-07-10WarningsExact identifier
ndc (package): 24286-1577-1
ndc (product): 24286-1577
ndc11 (package): 24286157701
spl set id: d3abce13-cc87-e661-e053-2a95a90a1b7c

Reported adverse events (FAERS/openFDA)#

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