FDA.reportPublic FDA data

Ludens Honey Licorice Throat Drops

Product NDC
52183-255
11-digit product format
521830255
Labeler code
52183
Product ID
52183-255_596b1954-2249-ab65-e063-6294a90abace
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Prestige Brands Holdings, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-10-29
Substance
MENTHOL
Active strength
1.6 mg/1
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
Ludens Honey Licorice Throat Drops
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616344Internal RxNorm lookup
637115Internal RxNorm lookup
637116Internal RxNorm lookup
753520Internal RxNorm lookup
1044433Internal RxNorm lookup
1146963Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5dc2baec-a9ed-4f6b-a7ed-76a5d35739acAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52183-255-30Ludens Honey Licorice Throat Drops30 in 1 BAGLOZENGE308

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ALUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3ALUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RLUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NLUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2
HONEYINACTIVE INGREDIENTY9H1V576FHLUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BLUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2
SOYBEAN OILINACTIVE INGREDIENT241ATL177ALUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554LUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52183-255LUDENS HONEY LICORICE THROAT DROPS (MENTHOL) LOZENGE LUDENS HONEY LEMON THROAT DROPS (MENTHOL) LOZENGE LUDENS ORIGINAL MENTHOL THROAT DROPS (MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]8Current NDC, Legacy NDC, 1 package rows20241212_5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac.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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753520Luden's 1 MG Oral LozengePSN5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
1146963Luden's 1.6 MG Oral LozengePSN5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
1044433Luden's 2.5 MG Oral LozengePSN5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
637115menthol 1 MG Oral LozengePSN5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
637116menthol 1.6 MG Oral LozengePSN5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
616344menthol 2.5 MG Oral LozengePSN5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
753520menthol 1 MG Oral Lozenge [Luden's]SBD5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
1146963menthol 1.6 MG Oral Lozenge [Luden's]SBD5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
1044433menthol 2.5 MG Oral Lozenge [Luden's]SBD5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
637115menthol 1 MG Oral LozengeSCD5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
637116menthol 1.6 MG Oral LozengeSCD5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
616344menthol 2.5 MG Oral LozengeSCD5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
753520Luden's 1 MG Oral LozengeSY5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
1146963Luden's 1.6 MG Oral LozengeSY5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
1044433Luden's 2.5 MG Oral LozengeSY5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8
1044433Ludens 2.5 MG Oral LozengeSY5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52183-255-305218302553030 LOZENGE in 1 BAG (52183-255-30) 30 lozenge2009-10-290000-00-00NoNoCurrent