FDA.reportPublic FDA data

Ludens

Product NDC
52183-227
11-digit product format
521830227
Labeler code
52183
Product ID
52183-227_596bafe3-fc62-46eb-e063-6294a90a9431
Type
HUMAN OTC DRUG
Nonproprietary name
pectin and menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Prestige Brands Holdings, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-15
Marketing end
2027-03-31
Substance
PECTIN; MENTHOL
Active strength
2.8; 2.5 mg/1; mg/1
NDC exclude flag
No
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
Brand name suffix
Dual Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PECTIN2.8 mg/1
MENTHOL2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89NA02M4RXInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2056063Internal RxNorm lookup
2056069Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d0213cb3-ec8e-40cc-82c9-694032f0490fAvailable 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
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
52183-227-25LudensDual Relief25 in 1 BAGLOZENGE253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52183-227LUDENS DUAL RELIEF (PECTIN AND MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]2Current NDC, Legacy NDC, 1 package rows20241113_d0213cb3-ec8e-40cc-82c9-694032f0490f.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 31 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oral Gel Oral Pain ReliefBENZOCAINE BENZALKONIUM CHLORIDESavvy Care and Cosmetics05ede7e4-5a0a-c942-e063-6294a90a8a242024-12-19WarningsExact identifier
application number: M022
EcoDent Ultimate Essential Mouthcare Sparkling Clean MintSODIUM BICARBONATELotus Brands, Inc.4a95c8c1-db7c-4791-ac58-3eac216a01262024-12-18WarningsExact identifier
application number: M022
EcoDent Ultimate Essential Mouthcare Spicy-Cool CinnamonSODIUM BICARBONATELotus Brands, Inc.6703b29d-cdc9-4c74-91c0-fb0c98dd043e2024-12-18WarningsExact identifier
application number: M022
Red Cross Oral Pain ReliefBENZOCAINEThe Mentholatum Companycbd41429-f730-4577-9f06-ef1831cf62e12024-12-17WarningsExact identifier
application number: M022
Red Cross Canker SoreBENZOCAINEThe Mentholatum Company54cfff96-6665-4b36-a15d-10bf6cf3a1f92024-12-17WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESIN1169566442981217f-f250-c090-e063-6294a90a85b02024-12-17WarningsExact identifier
application number: M022
Kank-A Mouth PainBENZOCAINEBlistex Inc.eebc03ba-f849-4e70-a653-834f383b6aa42024-12-17WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.8282a4a6-b77c-75fc-e053-2991aa0ad4ac2024-12-16WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories,Inc.9452bff4-8c08-eff9-e053-2a95a90a67ed2024-12-16WarningsExact identifier
application number: M022
PHENOLPHENOLCHAIN DRUG MARKETING ASSOCIATION INC.2379e23a-72fe-4e94-9d7e-9b623c0db1742024-12-13WarningsExact identifier
application number: M022
KANKA SoftBrushBENZOCAINE AND ZINC CHLORIDEBlistex Inc093f3545-1d8e-48a3-a533-e9c3ae6d740b2024-12-12WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.826eaef8-4457-3dc2-e053-2991aa0a528b2024-12-11WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.8281700c-10f9-841c-e053-2991aa0a918f2024-12-11WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.82824416-80de-76bd-e053-2a91aa0ad8b52024-12-11WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories,Inc.e3da0e63-a891-72bd-e053-2a95a90a58bc2024-12-11WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories, Inc.e3d924b5-0788-46d3-e053-2995a90a027b2024-12-11WarningsExact identifier
application number: M022
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.fa433031-7376-0e5b-e053-6394a90a5f752024-12-11WarningsExact identifier
application number: M022
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.eedf13dc-a009-027a-e053-2995a90a8ec82024-12-11WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola USA Inc.763e8234-60be-4b1f-9f78-01c574f35d0a2024-12-10WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola USA Inc.989f8509-cd28-48e7-9aa1-baddfbcac95a2024-12-10WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2056069Luden's Dual Relief 2.5 MG / 2.8 MG Oral LozengePSNd0213cb3-ec8e-40cc-82c9-694032f0490f3
2056063menthol 2.5 MG / pectin 2.8 MG Oral LozengePSNd0213cb3-ec8e-40cc-82c9-694032f0490f3
2056069menthol 2.5 MG / pectin 2.8 MG Oral Lozenge [Luden's Dual Relief]SBDd0213cb3-ec8e-40cc-82c9-694032f0490f3
2056063menthol 2.5 MG / pectin 2.8 MG Oral LozengeSCDd0213cb3-ec8e-40cc-82c9-694032f0490f3
2056069Luden's Dual Relief (menthol 2.5 MG / pectin 2.8) MG Oral LozengeSYd0213cb3-ec8e-40cc-82c9-694032f0490f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52183-227-255218302272525 LOZENGE in 1 BAG (52183-227-25) 25 lozenge2018-06-152027-03-31NoNoCurrent