FDA.reportPublic FDA data

Adult Cough Relief

Product NDC
83324-134
11-digit product format
833240134
Labeler code
83324
Product ID
83324-134_8bae585a-98a5-4e7b-8dab-6ff4c19c04ba
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
15 mg/5mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Adult Cough Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1090496Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-134-04Adult Cough Relief1 in 1 BOXLIQUID12
83324-134-04Adult Cough Relief118 mL in 1 BOTTLE, PLASTICLIQUID1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-134-04ML - Milliliter83324-134dc08b673-c5a5-46c4-ba7e-640bab51888012025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-134ADULT COUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2Current NDC, 2 package rows20240731_6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c.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 103 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique DiphenDIPHENHYDRAMINE HYDROCHLORIDEUnifirst First Aid Corporationb61ee2e0-2543-447d-9fc4-23363d46ce042025-09-08WarningsExact identifier
application number: M012
Green Guard Allergy 2 ReliefPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation16fddca9-a66b-41e6-9423-eaf091d3971e2025-09-08WarningsExact identifier
application number: M012
Medique Medi-PhenylPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationd7d62ac1-1333-4366-884b-26537766ce382025-09-08WarningsExact identifier
application number: M012
Unishield Sinus DecongestantPHENYLEPHRINE HCLUnishieldb8f68d9d-2d38-414a-e053-2a95a90a15ec2025-09-08WarningsExact identifier
application number: M012
McKesson Sinus Pain and Pressure ReliefACETAMINOPHEN, PHENYLEPHRINE HCLMcKesson Medical-Surgicale0cbb213-4f4f-4045-e053-2a95a90a2a182025-09-08WarningsExact identifier
application number: M012
Medique Medicidin DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation1f172d58-4050-424b-9743-130d8e618fe82025-09-08WarningsExact identifier
application number: M012
Medique Cold Cough ProductACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,Unifirst First Aid Corporatione8059137-efba-398c-e053-2a95a90a21f22025-09-08WarningsExact identifier
application number: M012
Medique Medi-MucusDEXTROMETHORPHAN HBR, GUAIFENESINUnifirst First Aid Corporationf3bb862a-9cb8-f644-e053-2a95a90a5f4f2025-09-08WarningsExact identifier
application number: M012
Physicians Care Cough and Sore ThroatMENTHOLAcme United Corporation4e02223d-f34b-333e-e054-00144ff8d46c2025-09-08WarningsExact identifier
application number: M012
Physicians Care Non-Drowsy Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAcme United186ec543-1f23-75d6-e063-6294a90a46b92025-09-08WarningsExact identifier
application number: M012
PhysiciansCare Sinus Non-DrowsyPHENYLEPHRINE HCLAcme United Corporationa6daf3ef-f386-4de4-b38e-d0b90c9ae62b2025-09-08WarningsExact identifier
application number: M012
PhysiciansCare Allergy Multi-Symptom ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEAcme United Corporationfd101c27-6ba9-4cd3-baec-a354504c37a02025-09-08WarningsExact identifier
application number: M012
Green Guard Honey Lemon Cough DropMENTHOL 8.6 MGUnifirst First Aid Corporation8a94f090-61d6-4909-e053-2995a90aee382025-09-08WarningsExact identifier
application number: M012
Green Guard Cough Drop ReliefMENTHOLUnifirst First Aid Corporation0fc4cb11-8ff9-4eff-9588-c73eef4e01372025-09-08WarningsExact identifier
application number: M012
Multi-Symptom Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,Unifirst First Aid Corporatione6ea6faf-baff-a130-e053-2a95a90a085a2025-09-08WarningsExact identifier
application number: M012
MEDIQUE Medikoff DropsMENTHOLUnifirst First Aid Corporation0d6b4443-16a1-4851-bb03-d7407167551d2025-09-08WarningsExact identifier
application number: M012
Medique Sugar Free Medikoff DropsMENTHOLUnifirst First Aid Corporation92d13e19-4e7b-4565-970e-504abf02579a2025-09-08WarningsExact identifier
application number: M012
Medique at Home DiphenDIPHENHYDRAMINE HCLUnifirst First Aid Corporationb56d1966-efd7-56eb-e053-2995a90a89b52025-09-08WarningsExact identifier
application number: M012
Medique ChlorphenCHLORPHENIRAMINE MALEATEUnifirst First Aid Corporationb3d5d161-8d4c-f1bb-e053-2a95a90a5bc52025-09-08WarningsExact identifier
application number: M012
Crane Safety Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDECrane Safety LLC968baa85-ce0e-0c3d-e053-2995a90ac03a2025-09-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c2
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCD6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c2
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSY6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c2
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSY6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-134-04833240134041 BOTTLE, PLASTIC in 1 BOX (83324-134-04) / 118 mL in 1 BOTTLE, PLASTIC2024-07-31NoNoCurrent