FDA.reportPublic FDA data

Premier Value

Product NDC
83698-883
11-digit product format
836980883
Labeler code
83698
Product ID
83698-883_47189ce9-6d4b-61cd-e063-6394a90a40f9
Type
HUMAN OTC DRUG
Nonproprietary name
Cough Drops Cherry
Dosage form
LOZENGE
Route
ORAL
Labeler
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-31
Substance
MENTHOL
Active strength
5.8 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Premier Value
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.8 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
2a2de803-900d-02f4-e063-6394a90a84ccAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83698-883-30Premier Value30 in 1 BAGLOZENGE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83698-883PREMIER VALUE (COUGH DROPS CHERRY) LOZENGE [XIAMEN KANG ZHONGYUAN BIOTECHNOLOGY CO., LTD.]2Current NDC, 1 package rows20241228_2a2de803-900d-02f4-e063-6394a90a84cc.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 138 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
careone tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINAmerican Sales Company6c90fccf-0e6f-43df-9468-d8ece8ded0092024-11-11WarningsExact identifier
application number: M012
good sense night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company89dc1423-d097-47a8-9025-eab5381cca262024-11-11WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC10f9627b-edda-422a-b01f-7066f9c983352024-11-11WarningsExact identifier
application number: M012
nighttime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED17c3fe42-3c40-4405-80b7-b3f9e4aa83762024-11-11WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B1dd36aa7-f085-4350-8cf2-f9fa29b583e42024-11-11WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCa7f9f1d0-7498-461c-b4e8-4c92cf3feae82024-11-11WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalgreen Companybd079f5d-0a38-40e6-9661-e8236c88a24d2024-11-11WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANPAI Holdings, LLC dba PAI Pharmaff970fff-d1a3-4322-83b4-34e361431a1c2024-11-11WarningsExact identifier
application number: M012
topcare tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCe1118592-30ac-4505-9f38-c6d395c4cf5b2024-11-11WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC624b8029-9fdb-4908-a13b-f9dd750301202024-11-11WarningsExact identifier
application number: M012
Biofreeze ColorlessMENTHOLA-S Medication Solutionscc1cba14-da40-4d7d-b522-b5c648798e962024-11-11WarningsExact identifier
application number: M012
foster and thrive nighttime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLC298b7754-d0d8-496d-9949-4c346cb11e342024-11-11WarningsExact identifier
application number: M012
leader tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leaderb418c10c-528b-4395-944e-af959b639ec22024-11-10WarningsExact identifier
application number: M012
equaline adult tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINUnited Natural Foods, Inc. dba UNFIf7c753f8-4b12-4797-a599-736d597bc1bc2024-11-10WarningsExact identifier
application number: M012
foster and thrive adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINStrategic Sourcing Services LLCf8933226-fbc9-44e3-a90f-4e6c1dbdb7b72024-11-10WarningsExact identifier
application number: M012
dg health adult tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc81f12484-ddf7-49c6-b530-3a81d62ab40d2024-11-10WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRetail Business Services, LLC230fa1ea-ae7c-425e-8447-79a90c96ae9e2024-11-10WarningsExact identifier
application number: M012
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Companycb8a1d81-b1a3-4217-b157-9e5d398f202d2024-11-09WarningsExact identifier
application number: M012
PhysiciansCare Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEAcme United Corporation5e31b1ff-291f-7b8c-e053-2a91aa0aedbc2024-11-09WarningsExact identifier
application number: M012
DurafluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.55fffc1d-8449-4c28-a391-c6f60dd856222024-11-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476973menthol 5.8 MG Oral LozengePSN2a2de803-900d-02f4-e063-6394a90a84cc3
476973menthol 5.8 MG Oral LozengeSCD2a2de803-900d-02f4-e063-6394a90a84cc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83698-883-308369808833030 LOZENGE in 1 BAG (83698-883-30) 30 lozenge2023-07-31NoNoCurrent