Cough Drops

Product NDC
83455-202
11-digit product format
834550202
Labeler code
83455
Product ID
83455-202_23f97a0e-cfab-d448-e063-6294a90acf8c
Type
HUMAN OTC DRUG
Nonproprietary name
Cherry
Dosage form
PASTILLE
Route
ORAL
Labeler
United Natural Foods, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-12
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
Cough Drops
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
f9f0e853-6997-a49b-e053-6294a90aa4b8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83455-202-01Cough Drops30 in 1 BAGPASTILLE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83455-202COUGH DROPS (CHERRY) PASTILLE [UNITED NATURAL FOODS, INC.]2Current NDC, 1 package rows20241010_f9f0e853-6997-a49b-e053-6294a90aa4b8.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 119 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafewayf1d0edd5-fe58-4de0-98f4-07fb24bd0ac22025-02-19WarningsExact identifier
application number: M012
Coricidin HBP Cold and FluACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEBayer HealthCare LLC.763a5334-a741-4678-9947-6037766224502025-02-18WarningsExact identifier
application number: M012
Sof Skin Vaporizing Chest Rub and Cough SuppressantMENTHOL AND CAMPHOR AND EUCALYPTUS OILViny Health and Beauty Inc46ae16a4-b8a7-44de-ae1a-9bb503c15ea02025-02-18WarningsExact identifier
application number: M012
Pain Reliever PMACETAMINOPHEN DIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)4897d1df-4fb3-46e2-bbf0-847e964dca0a2025-02-18WarningsExact identifier
application number: M012
meijer EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bee7e4f-1813-1bdf-e063-6294a90a6a322025-02-17WarningsExact identifier
application number: M012
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCLACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCLKroger Companya24f09d9-60f1-853a-e053-2a95a90ae1fa2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFAMILY DOLLAR SERVICESa7343bea-53cc-4621-e053-2a95a90a2a5f2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCLFAMILY DOLLARaa8f6dd0-d19f-0c10-e053-2a95a90a1e8a2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGHT DAY COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCLFAMILY DOLLARaa8ebccf-6813-2dca-e053-2a95a90a032b2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENTH NIGHT COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFAMILY DOLLARaa8f0465-1595-0b0f-e053-2a95a90a00812025-02-15WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINKROGER COMPANY9bb7aaf0-6698-9a5c-e053-2a95a90a097c2025-02-14WarningsExact identifier
application number: M012
DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH-E-Bdb432947-fe02-79b2-e053-2a95a90af4a92025-02-14WarningsExact identifier
application number: M012
Halls Sugar Free CherryMENTHOLMondelez Global LLCea8dfe96-f6a4-4172-bf9e-ae3cf606ff502025-02-14WarningsExact identifier
application number: M012
Halls Sugar Free WatermelonMENTHOLMondelez Global LLCc4c090ca-f083-74e0-e053-2a95a90a9d602025-02-14WarningsExact identifier
application number: M012
Tukol Max ActionOXYMETAZOLINE HYDROCHLORIDEGenomma Lab USA73358103-43dc-4b11-9c89-9a6ba45bf1af2025-02-14WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association Inc.6c4e867b-24b9-4525-9fab-10f1e7910b132025-02-13WarningsExact identifier
application number: M012
DAYTIME- NIGHTTIME COLD AND FLUDAYTIME NIGHTTIME COLD AND FLUTARGET CORP9def204a-ee1e-6868-e053-2995a90a76b82025-02-13WarningsExact identifier
application number: M012
Daytime Cold and Flu and Nigttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.f2c11b63-278f-64de-e053-2995a90a5aae2025-02-12WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLBETTER LIVING BRANDS LLC.f29c604a-271d-a702-e053-2a95a90a34272025-02-12WarningsExact identifier
application number: M012
Nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.f2c01090-645c-1efe-e053-2995a90a7df52025-02-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476973menthol 5.8 MG Oral LozengePSNf9f0e853-6997-a49b-e053-6294a90aa4b82
476973menthol 5.8 MG Oral LozengeSCDf9f0e853-6997-a49b-e053-6294a90aa4b82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83455-202-018345502020130 PASTILLE in 1 BAG (83455-202-01) 30 pastille2023-05-12NoNoCurrent