FDA.reportPublic FDA data

Mixed Berry Throat and Cough Lozenges

Product NDC
69842-377
11-digit product format
698420377
Labeler code
69842
Product ID
69842-377_48842646-9907-f682-e063-6294a90a3d18
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LOZENGE
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-15
Substance
BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
7.5; 5 mg/1; mg/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Standardized Chemical Allergen [EPC], 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
Mixed Berry Throat and Cough Lozenges
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE7.5 mg/1
DEXTROMETHORPHAN HYDROBROMIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039251Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
737b1c88-1a44-68cf-e053-2991aa0a35b6Available 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
69842-377-18Mixed Berry Throat and Cough Lozenges18 in 1 BLISTER PACKLOZENGE188

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-377MIXED BERRY THROAT AND COUGH LOZENGES (BENZOCAINE) LOZENGE [CVS PHARMACY]6Current NDC, Legacy NDC, 1 package rows20241203_737b1c88-1a44-68cf-e053-2991aa0a35b6.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 125 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCaebc7cf8-aaf7-4746-89f5-a64d0be1641e2024-12-26WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion ReliefGUAIFENESINStrategic Sourcing Services LLCa1661a66-5e8c-4144-9c82-cbbcc75fb2222024-12-23WarningsExact identifier
application number: M012
Geri DrylDIPHENHYDRAMINE HCLGERI-CARE PHARMACEUTICALS, CORP34d36146-6827-4800-8483-c0edb8f4cc282024-12-23WarningsExact identifier
application number: M012
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp6299e352-116e-43f2-b40f-c704a7bd5d612024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion ReliefGUAIFENESINUnited Natural Foods, Inc. dba UNFIad9fde8b-10cd-4778-917d-1ed6b67e5ab12024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINUnited Natural Foods, Inc. dba UNFIa40f5893-eb96-4e0e-b965-d78293c48dc92024-12-23WarningsExact identifier
application number: M012
Tukol X-Pecto Miel Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.b9d32964-5bd7-44b0-be98-827d5310ed4f2024-12-20WarningsExact identifier
application number: M012
Halls Honey VanillaMENTHOLMondelez Global LLC8e94a1b8-8915-4595-b097-8a0a319d54aa2024-12-20WarningsExact identifier
application number: M012
Halls Sugar Free Mentho-LyptusMENTHOLMondelez Global LLC96046858-c57b-426e-8279-91b35e05bcdb2024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Best ChoiceLEVMETAMFETAMINEValu Merchandisers Company3f1c086c-bc22-4abb-9921-565a13f30c202024-12-20WarningsExact identifier
application number: M012
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTWalgreens77924474-ccc7-497b-9168-91490bcfadfc2024-12-20WarningsExact identifier
application number: M012
LevmetamfetamineLEVMETAMFETAMINEMeijer, Inc.d11e916f-90a6-4099-bf83-75f2dfbd62662024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, DG healthLEVMETAMFETAMINEDolgencorp Inc.5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd32024-12-20WarningsExact identifier
application number: M012
Tukol Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.aef2ad43-145d-4abc-bccc-2c5fdd6882f92024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, TopCare healthLEVMETAMFETAMINETopco Associates LLC8f995561-759a-4837-a82a-640417a6f8892024-12-20WarningsExact identifier
application number: M012
Childrens CoughDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores, Inc.50a0eaa5-fa73-4d84-86fc-3546c85cf3532024-12-20WarningsExact identifier
application number: M012
Equate Childrens Multi symptom Cold NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee2024-12-20WarningsExact identifier
application number: M012
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTC.D.M.A., Inc.904b7e21-cce5-4b96-afc1-b36f532f98ac2024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, EqualineLEVMETAMFETAMINESupervalu Inc.44f72f34-d0b8-421f-b240-86286de874cf2024-12-20WarningsExact identifier
application number: M012
Childrens TussnexACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company19e9678d-ac34-4af8-a80f-d08fce0a5f0e2024-12-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039251dextromethorphan HBr 5 MG / benzocaine 7.5 MG Oral LozengePSN737b1c88-1a44-68cf-e053-2991aa0a35b68
1039251benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral LozengeSCD737b1c88-1a44-68cf-e053-2991aa0a35b68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-377-186984203771818 LOZENGE in 1 BLISTER PACK (69842-377-18) 18 lozenge2018-08-150000-00-00NoNoCurrent