FDA.reportPublic FDA data

Equate Benz-Dex Cough and Throat Lozenges

Product NDC
79903-042
11-digit product format
799030042
Labeler code
79903
Product ID
79903-042_46a2f7a9-dd2f-55f5-e063-6394a90a9d03
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LOZENGE
Route
ORAL
Labeler
Walmart
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-23
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
Equate Benz-Dex Cough and Throat 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
c0a6cb7f-a247-e610-e053-2a95a90a4199Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-042-18Equate Benz-Dex Cough and Throat Lozenges18 in 1 BLISTER PACKLOZENGE185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-042EQUATE BENZ-DEX COUGH AND THROAT LOZENGES (BENZOCAINE) LOZENGE [WALMART]4Current NDC, Legacy NDC, 1 package rows20241203_c0a6cb7f-a247-e610-e053-2a95a90a4199.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 89 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation1affbef6-dd27-40c2-a5d3-b121aa62496a2025-11-15WarningsExact identifier
application number: M012
Cold and Flu Day, NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Companyb9adfb5d-6576-4ff8-a7d7-a89b867c52922025-11-14WarningsExact identifier
application number: M012
PECGEN DMXDEXTROMETHORPHAN HBR, GUAIFENESINKRAMER NOVISa627824c-5e3d-4672-a047-6c801b50b4322025-11-14WarningsExact identifier
application number: M012
Supress DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINKRAMER NOVIS7da0611e-729c-4cf8-88f3-f8877b9f5cfa2025-11-14WarningsExact identifier
application number: M012
G-ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Novisc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc2025-11-14WarningsExact identifier
application number: M012
Tussi Pres BDEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVISd0afa44c-3acf-42a5-9889-4e9c102252562025-11-14WarningsExact identifier
application number: M012
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb2c0692c-ed0b-4fcf-b88d-59a788b124c62025-11-14WarningsExact identifier
application number: M012
Guaifenesin 400mgGUAIFENESINMarlex Pharmaceuticals Inc13f4db4e-687e-9d7b-e063-6294a90ab0882025-11-13WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINMarlex Pharmaceuticals Inc13b8f480-d1ac-d70c-e063-6394a90ab4f42025-11-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLPD-Rx Pharmaceuticals, Inc.c1873a4c-661f-4896-bcc0-f6d3a655de942025-11-13WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLCc24b9489-208c-472b-8ae5-c6e86c12e04d2025-11-13WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Chest Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLC8c821671-dc68-4e27-aa87-b4e45ade98172025-11-13WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Cough Plus Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC6a6f5da8-6433-4284-8df7-2d5b099b74dc2025-11-13WarningsExact identifier
application number: M012
equaline allergyDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI8e4eb1eb-5b55-4531-94d2-998425ec80ed2025-11-13WarningsExact identifier
application number: M012
Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.7a78f24b-7c23-4318-99dc-90c05db185b12025-11-13WarningsExact identifier
application number: M012
ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Noviscffd6d5f-0cb2-4d38-bdb0-6a21120418cc2025-11-13WarningsExact identifier
application number: M012
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb6da1659-8c79-4cce-a817-907a7f061a2d2025-11-13WarningsExact identifier
application number: M012
Tussi PresGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novis0d4ee530-2a5c-41a0-88bf-ac92d538661b2025-11-12WarningsExact identifier
application number: M012
4 Way Fast ActingPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa8fc41c7-4425-41b8-b1c6-eb22ac0547342025-11-12WarningsExact identifier
application number: M012
Quality Choice Vapor SteamCAMPHOR (SYNTHETIC)Chain Drug Marketing Association, Inc.1f1e6be5-d407-330c-e063-6294a90a4e802025-11-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039251dextromethorphan HBr 5 MG / benzocaine 7.5 MG Oral LozengePSNc0a6cb7f-a247-e610-e053-2a95a90a41995
1039251benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral LozengeSCDc0a6cb7f-a247-e610-e053-2a95a90a41995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79903-042-187990300421818 LOZENGE in 1 BLISTER PACK (79903-042-18) 18 lozenge2021-04-230000-00-00NoNoCurrent