FDA.reportPublic FDA data

Giltuss Honey Cough and Chest Congestion

Product NDC
65852-005
11-digit product format
658520005
Labeler code
65852
Product ID
65852-005_3ff240ba-90b3-4c17-e063-6394a90ac56f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Dextrum Laboratories, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-22
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
200; 20 mg/10mL; mg/10mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
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
Giltuss Honey Cough and Chest Congestion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal 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
996520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ff240ba-90b2-4c17-e063-6394a90ac56fAvailable 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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-005-04Giltuss Honey Cough and Chest Congestion118 mL in 1 BOTTLE, PLASTICLIQUID1181
65852-005-04Giltuss Honey Cough and Chest Congestion1 in 1 CARTONLIQUID11

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 60 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLCbab078bb-f6b0-4394-84de-92b2c582b5da2026-01-12WarningsExact identifier
application number: M012
Nasal Decongestant PE Non-Drowsy Maximum StrengthPHENYLEPHRINE HCLCHAIN DRUG MARKETING ASSOCIATION INCbf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d2026-01-12WarningsExact identifier
application number: M012
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacy022c3083-c611-47d0-aa93-d6c7612e7a472026-01-11WarningsExact identifier
application number: M012
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacybf73d15a-9d68-42fa-bfee-d25748215f972026-01-11WarningsExact identifier
application number: M012
GUAIFENESIN 400MG CAPLETSGUAIFENESINGendose Pharmaceuticals, LLCe7b82ec7-ef23-50c1-e053-2a95a90a662f2026-01-10WarningsExact identifier
application number: M012
Daytime Cold and FluDAYTIME COLD AND FLUAllegiant Health69ed2da0-16b2-49eb-91b4-cc5cf328c8172026-01-09WarningsExact identifier
application number: M012
HyVee Cough Drops Original HerbMENTHOLHY-VEE, INC47f81e54-0ce4-439d-e063-6294a90a2abe2026-01-09WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLA-S Medication Solutionsa5809774-ed52-4f54-b48e-888631e0223d2026-01-09WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLA-S Medication Solutions5767f546-a751-4583-a8b7-971175c27ef02026-01-09WarningsExact identifier
application number: M012
Thompson Cough and Cold Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE, GUAIFENESIN, ,Thompsone77725b1-15da-35bd-e053-2a95a90ad6ba2026-01-08WarningsExact identifier
application number: M012
Mucosan Childrens Multi-Symptom GrapeDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.266c8cce-cdf9-557d-e063-6394a90a9bc32026-01-08WarningsExact identifier
application number: M012
Mucosan Multi-Symptom HoneyDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMenper Distributors, Inc.2669c620-ab70-abaa-e063-6394a90a58e72026-01-08WarningsExact identifier
application number: M012
Mucosan Multi-Symptom CherryDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.26b8c06d-4a72-3979-e063-6394a90a96d72026-01-08WarningsExact identifier
application number: M012
Mucosan Max with AcetaminophenACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.26a4861b-5d8e-9ec6-e063-6394a90af5772026-01-08WarningsExact identifier
application number: M012
Mucosan Severe Multi-SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMenper Distributors, Inc.26a69342-f65f-cb46-e063-6394a90ade102026-01-08WarningsExact identifier
application number: M012
HyVee Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.e4e15c13-f583-4484-a5f0-f04c39c7b7c92026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non DrowsyASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a355d987-77ce-9e32-e053-2995a90a64312026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e07931fc-f753-1aeb-e053-2a95a90ada3f2026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and NightASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.fc60af2f-83cb-99ea-e053-6394a90a0b3b2026-01-08WarningsExact identifier
application number: M012
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e17eb929-209d-a2d1-e053-2a95a90a4cf32026-01-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN3ff240ba-90b2-4c17-e063-6394a90ac56f1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3ff240ba-90b2-4c17-e063-6394a90ac56f1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3ff240ba-90b2-4c17-e063-6394a90ac56f1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY3ff240ba-90b2-4c17-e063-6394a90ac56f1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY3ff240ba-90b2-4c17-e063-6394a90ac56f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65852-005-04658520005041 BOTTLE, PLASTIC in 1 CARTON (65852-005-04) / 118 mL in 1 BOTTLE, PLASTIC2020-06-22NoNoCurrent