FDA.reportPublic FDA data

QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE

Product NDC
83324-307
11-digit product format
833240307
Labeler code
83324
Product ID
83324-307_463c93a9-4ea7-6a86-e063-6394a90a5ed3
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-14
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
5.8 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage83324-307-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage83324-307-25f5e01cc5f278…a2eaf40c39c3…

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
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM5.8 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
476973Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f6ee01c-baad-489f-b2fd-0ef506916ee4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-307-25QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE25 in 1 BAGLOZENGE254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-307QUALITY CHOICE COUGH DROPS BLACK CHERRY SUGAR FREE (MENTHOL) LOZENGE [CHAIN DRUG MARKETING ASSOCIATION, INC.]1Current NDC, 1 package rows20240822_8f6ee01c-baad-489f-b2fd-0ef506916ee4.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 175 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freegells Cough Drops Menthol Honey LemonMENTHOLRiclan S.A.f6271e85-9ca2-41d3-9bff-a13670ac5b802023-10-26WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol StrawberryMENTHOLRiclan S.A.da2bbc92-7d96-4f3e-89e2-c2a9e3e4b4572023-10-26WarningsExact identifier
application number: M012
DG Health Cough Drops Assorted FlavorsMENTHOLDollar General Corporationc731d255-40f2-3cb3-e053-2a95a90a88772023-10-26WarningsExact identifier
application number: M012
ALKA SELTZER PLUS Cold Day and Night EffervescentASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATESincronia Logistica, S.A. de C.V.c478df69-823a-4112-8f44-323249a9f38f2023-10-23WarningsExact identifier
application number: M012
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLP & L Development, LLC169006cb-7dc2-4113-a289-0b1f14e784b72023-10-23WarningsExact identifier
application number: M012
Night-Time Cold and Flu ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealthLife of USA2ffd62a6-703f-4cb0-bb13-49719c004d002023-10-21WarningsExact identifier
application number: M012
Day-Time Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHANHealthLife of USAc5f6cf22-2aaa-40e1-b7b3-448e55898d622023-10-21WarningsExact identifier
application number: M012
PENTREXCILINAACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEHealthlife of USAae9ada14-0ec8-4c01-a874-237f2108936a2023-10-21WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINAPNAR PHARMA LPe5004c10-3877-c199-e053-2a95a90aa8ac2023-10-21Boxed warning, WarningsExact identifier
application number: M012
Day and Night Multi Symptom Cold and Flu ReliefDAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEFIntrivo Diagnostics Inc.a311bf39-de6c-4ed5-949e-718ad8be1e492023-10-13WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0d65c4a9-938c-4a89-b1f1-d9ada8a8c5872023-10-10WarningsExact identifier
application number: M012
Triacting Daytime Cold Cough ChildrensDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8656aa2e-9546-4de4-9ecc-ce99bf9033332023-10-10WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCLWalgreensa33ae35b-1cde-4a3d-a836-3b169e4f1bb92023-10-10WarningsExact identifier
application number: M012
Severe Cold and Cough Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)553d01a9-e8ad-4797-b55b-32f134f08af92023-10-10WarningsExact identifier
application number: M012
Mucus Relief Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens8781e2c5-ad46-4615-a0d9-879590e86f952023-10-10WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens419df833-1f33-45cf-bab3-730c928d58872023-10-10WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)93a5cb36-3262-4224-a5be-5ea1619a67bd2023-10-10WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINCVS Pharmacy782fb103-cd9f-4e8c-8f3a-1fb131b9eda62023-10-09WarningsExact identifier
application number: M012
Cold and Congestion Childrens NighttimeDIPHENHYDRAMINE HCI, PHENYLEPHRINE HCLWalgreensa7847413-e556-4f88-8a7f-a8528afbe9272023-10-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLC06d2c6cf-0adb-91b9-e063-6294a90aff522023-10-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476973menthol 5.8 MG Oral LozengePSN8f6ee01c-baad-489f-b2fd-0ef506916ee44
476973menthol 5.8 MG Oral LozengeSCD8f6ee01c-baad-489f-b2fd-0ef506916ee44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-307-258332403072525 LOZENGE in 1 BAG (83324-307-25) 25 lozenge2024-06-14NoNoCurrent