FDA.reportPublic FDA data

LUDENS SUGAR FREE WILD CHERRY THROAT

Product NDC
52183-249
11-digit product format
521830249
Labeler code
52183
Product ID
52183-249_5a20a239-e6d6-626d-e063-6294a90afca2
Type
HUMAN OTC DRUG
Nonproprietary name
Pectin
Dosage form
LOZENGE
Route
ORAL
Labeler
Prestige Brands Holdings, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-07-12
Substance
PECTIN
Active strength
2.8 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52183-24952183-249-18DDiscontinued by firm2026-10-02

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…

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 SUGAR FREE WILD CHERRY THROAT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PECTIN2.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637146Internal RxNorm lookup
1044444Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
274fc80c-e5b2-41c7-a119-287d6e8a2258Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52183-249-18LUDENS SUGAR FREE WILD CHERRY THROAT18 in 1 BAGLOZENGE189
52183-249-25LUDENS SUGAR FREE WILD CHERRY THROAT25 in 1 BAGLOZENGE259
52183-249-75LUDENS SUGAR FREE WILD CHERRY THROAT75 in 1 BAGLOZENGE759

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PECTINACTIVE INGREDIENT89NA02M4RXLUDENS SUGAR FREE WILD CHERRY THROAT (PECTIN) LOZENGE [BLACKSMITH BRANDS, INC.]2
PECTINACTIVE MOIETY89NA02M4RXLUDENS SUGAR FREE WILD CHERRY THROAT (PECTIN) LOZENGE [BLACKSMITH BRANDS, INC.]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9LUDENS SUGAR FREE WILD CHERRY THROAT (PECTIN) LOZENGE [BLACKSMITH BRANDS, INC.]2
CITRIC ACIDINACTIVE INGREDIENT2968PHW8QPLUDENS SUGAR FREE WILD CHERRY THROAT (PECTIN) LOZENGE [BLACKSMITH BRANDS, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLUDENS SUGAR FREE WILD CHERRY THROAT (PECTIN) LOZENGE [BLACKSMITH BRANDS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALUDENS SUGAR FREE WILD CHERRY THROAT (PECTIN) LOZENGE [BLACKSMITH BRANDS, INC.]2
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPLUDENS SUGAR FREE WILD CHERRY THROAT (PECTIN) LOZENGE [BLACKSMITH BRANDS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52183-249LUDENS SUGAR FREE WILD CHERRY THROAT (PECTIN) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]8Current NDC, Legacy NDC, 3 package rows20250116_274fc80c-e5b2-41c7-a119-287d6e8a2258.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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CrystLCare Regeneration PlusPOTASSIUM NITRATE, SODIUM FLUORIDEGreenMark Biomedical Inc.4f86d0a0-d73e-5605-e063-6394a90adb382026-09-14WarningsExact identifier
application number: M022
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
application number: M022
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
application number: M022
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
application number: M022
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
application number: M022
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
application number: M022
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
application number: M022
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsExact identifier
application number: M022
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
application number: M022
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
application number: M022
ndc (product): 52183-249
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsExact identifier
application number: M022
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044444Luden's Drops 2.8 MG Oral LozengePSN274fc80c-e5b2-41c7-a119-287d6e8a22589
637146pectin 2.8 MG Oral LozengePSN274fc80c-e5b2-41c7-a119-287d6e8a22589
1044444pectin 2.8 MG Oral Lozenge [Luden's Drops]SBD274fc80c-e5b2-41c7-a119-287d6e8a22589
637146pectin 2.8 MG Oral LozengeSCD274fc80c-e5b2-41c7-a119-287d6e8a22589
1044444Luden's Drops 2.8 MG Oral LozengeSY274fc80c-e5b2-41c7-a119-287d6e8a22589

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52183-249-1352183024913130 LOZENGE in 1 BAG (52183-249-13) 130 lozenge2025-11-05NoNoCurrent
52183-249-185218302491818 LOZENGE in 1 BAG (52183-249-18) 18 lozenge2010-07-120000-00-00NoNoCurrent
52183-249-255218302492525 LOZENGE in 1 BAG (52183-249-25) 25 lozenge2010-07-120000-00-00NoNoCurrent
52183-249-755218302497575 LOZENGE in 1 BAG (52183-249-75) 75 lozenge2010-07-120000-00-00NoNoCurrent