FDA.reportPublic FDA data

Bactimicina for Sore Throat

Product NDC
24286-1577
11-digit product format
242861577
Labeler code
24286
Product ID
24286-1577_5d1a6f1c-028a-1302-e063-6394a90a3a73
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LOZENGE
Route
ORAL
Labeler
DLC Laboratories, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-21
Substance
BENZOCAINE
Active strength
15 mg/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Bactimicina for Sore Throat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE15 mg/1

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-01-30Bactimicina Lozenge
2024-01-30Bactimicina Lozenge
2024-01-30Bactimicina Lozenge
2023-08-14Bactimicina Lozenge
2023-08-14Bactimicina Lozenge
2023-08-14Bactimicina Lozenge
2023-07-28Bactimicina Lozenge
2023-07-28Bactimicina Lozenge
2023-07-28Bactimicina Lozenge

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24286-1577-1Bactimicina for Sore Throat6 in 1 BLISTER PACKLOZENGE62
24286-1577-1Bactimicina for Sore Throat3 in 1 BOXLOZENGE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24286-1577BACTIMICINA FOR SORE THROAT (BENZOCAINE) LOZENGE [DLC LABORATORIES, INC.]2Current NDC, Legacy NDC, 2 package rows20240711_d3abce13-cc87-e661-e053-2a95a90a1b7c.zip

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 36 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TEXACLEAR PAIN RELIEVERCAFFEINE, CHOLINE SALICYLATEGM Pharmaceuticals, INC065bd10c-3bcf-486f-a49c-40544127007f2025-10-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENASCLEMED USA INC.db8e6702-88ac-4db2-9dd8-7d0ed997c2b52025-10-14WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyfa33f6ef-522b-4630-9716-92371d9cd24a2025-10-14WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENRite Aid Corporationa8bb4f45-7a1a-4bf7-92ca-3afd508032f32025-10-09WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENHealth Pharma USA LLCb15a7dcb-f143-4aea-8850-d0aacbf709b62025-10-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.3f96aeb1-a533-4d36-9a1f-62fc094b67542025-10-08WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreensf2eb9575-d527-44c7-aa5e-efabfd9a02782025-10-07WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INCbbc704e5-79f6-4c72-846b-cc30c5c43cb42025-10-07WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRINCHAIN DRUG MARKETING ASSOCIATION INCf1ce15a3-9824-4eb5-910a-39078165f3852025-10-07WarningsExact identifier
application number: M013
BupropiDexDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.90cc9bcd-7891-4324-a1f4-f6df7a0457e02025-10-06WarningsExact identifier
application number: M013
DextabsDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.71b567df-844a-4563-b85a-f4592233f37d2025-10-06WarningsExact identifier
application number: M013
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINERising Pharma Holdings, Inc.50f72713-50f5-4bab-9e96-b9fa73c9df1f2025-10-06WarningsExact identifier
application number: M013
OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mLACETAMINOPHEN 160 MG / 5 MLMEDWISE LIFESCIENCES INC.40507559-aee4-a603-e063-6394a90afc4f2025-10-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.004c39cd-b4f4-1cae-e063-6394a90a06972025-10-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENFamily Dollar (FAMILY WELLNESS)43573e35-6776-446e-aa28-75c8edc5b98d2025-10-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENFamily Dollar (FAMILY WELLNESS)f8e5fab4-1212-4c60-a160-9b782f76a1982025-10-03WarningsExact identifier
application number: M013
CVS AcetaminophenACETAMINOPHENCVS Pharmacy3d71a0aa-5e03-0bdc-e063-6294a90a66342025-10-02WarningsExact identifier
application number: M013
Chewable AspirinASPIRINChain Drug Marketing Association, Inc.cc865351-34e8-4e8e-b8bf-23336c45bc612025-10-02WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENBryant Ranch Prepack8e40f8f1-03c5-444b-8b5e-4532c3146e472025-10-02WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINProficient Rx LP9f9355f7-024a-4adc-bb4c-2d9c0dd0cb772025-10-01WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1110712Bactimicina For Sore Throat 15 MG Oral LozengePSNd3abce13-cc87-e661-e053-2a95a90a1b7c2
199071benzocaine 15 MG Oral LozengePSNd3abce13-cc87-e661-e053-2a95a90a1b7c2
1110712benzocaine 15 MG Oral Lozenge [Bactimicina Sore Throat]SBDd3abce13-cc87-e661-e053-2a95a90a1b7c2
199071benzocaine 15 MG Oral LozengeSCDd3abce13-cc87-e661-e053-2a95a90a1b7c2
1110712Bactimicina Sore Throat 15 MG Oral LozengeSYd3abce13-cc87-e661-e053-2a95a90a1b7c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24286-1577-1242861577013 BLISTER PACK in 1 BOX (24286-1577-1) / 6 LOZENGE in 1 BLISTER PACK3 blister pack2021-12-210000-00-00NoNoCurrent