FDA.reportPublic FDA data

Mixed Berry Sore Throat and Cough Lozenges

Product NDC
37808-062
11-digit product format
378080062
Labeler code
37808
Product ID
37808-062_45dede8d-732e-7d24-e063-6294a90aa3e7
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LOZENGE
Route
ORAL
Labeler
HEB
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-13
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
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
Mixed Berry Sore Throat and Cough Lozenges
Listing expiration
2026-12-31

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
3063ea93-6bc2-1d18-e054-00144ff88e88Available 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
37808-062-18Mixed Berry Sore Throat and Cough Lozenges18 in 1 CARTONLOZENGE188

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-062MIXED BERRY SORE THROAT AND COUGH LOZENGES (BENZOCAINE) LOZENGE [HEB]7Current NDC, Legacy NDC, 1 package rows20241202_3063ea93-6bc2-1d18-e054-00144ff88e88.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 67 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sorbutuss NRSORBUTUSSDextrum Laboratories Inc.304f1d5a-218c-51ae-e054-00144ff88e882025-12-26WarningsExact identifier
application number: M012
caring mill Cough drops CHERRYMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a28aa-00e9-8b9d-e063-6394a90ace2a2025-12-26WarningsExact identifier
application number: M012
Creamy Strawberry Flavor Cough DropCREAMY STRAWBERRY FLAVOR COUGH DROP WITH MENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2749b83a-ea4f-d8ca-e063-6394a90a69b72025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f4a026-c4d2-2645-e063-6294a90aac582025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a13b5-6fcb-70ed-e063-6394a90a7fb32025-12-26WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropHONEY LEMON FLAVOR COUGH DROPXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a4802-7c02-ccce-e063-6394a90ad71d2025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2749f353-9286-15b9-e063-6394a90a76932025-12-26WarningsExact identifier
application number: M012
Leader Cough Drops Vanilla HoneyMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a93c2c-a663-e3d1-e063-6394a90ad8592025-12-26WarningsExact identifier
application number: M012
Nite-Time COLD/FLU MedicineACETAMINOPHENAptaPharma Inc.344440bc-d810-4296-93ec-e6ae6673856b2025-12-26WarningsExact identifier
application number: M012
Nite-Time COLD/FLU Medicine CherryACETAMINOPHENAptaPharma Inc.87c2b823-ed88-44f3-8f6a-df30430b40f32025-12-26WarningsExact identifier
application number: M012
TUSSIN CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAptaPharma Inc.c005c6cf-7891-463e-b65d-1129ad4bf6ec2025-12-26WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEAptaPharma Inc.b2cef61f-ab54-4a20-a7f7-6d3da4754e8b2025-12-26WarningsExact identifier
application number: M012
CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVORDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAptaPharma Inc.9ae6fe74-80cd-482a-b3b9-3acafd6708ec2025-12-26WarningsExact identifier
application number: M012
Tussin ExpectorantGUAIFENESINAptaPharma, Inc.ca8fa216-09c1-42b2-a95b-fa3d0f13363c2025-12-26WarningsExact identifier
application number: M012
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCa9875dc9-6a27-413c-a2c7-68a86483ffc12025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC3b7e0ee7-4dda-4bbe-842c-6cbbc208acd52025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f2025-12-26WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MGPioneer Life Sciences, LLC3ce0f096-906e-47eb-8061-0ac1e9d8ea552025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC1194c338-e115-4105-93d8-9ab833c431932025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC9c9e558d-d991-4a2e-aa13-37c0b08071e62025-12-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039251dextromethorphan HBr 5 MG / benzocaine 7.5 MG Oral LozengePSN3063ea93-6bc2-1d18-e054-00144ff88e888
1039251benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral LozengeSCD3063ea93-6bc2-1d18-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-062-183780800621818 LOZENGE in 1 CARTON (37808-062-18) 18 lozenge2016-04-130000-00-00NoNoCurrent