FDA.reportPublic FDA data

Mucus Relief Severe Congestion and Cough

Product NDC
69256-337
11-digit product format
692560337
Labeler code
69256
Product ID
69256-337_bc527934-5f5f-45c2-aa3a-cd1d67dbd61b
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Harris Teeter, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-28
Marketing end
2027-05-28
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20; 400; 10 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
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
Mucus Relief Severe Congestion and Cough
Brand name suffix
Maximum Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043543Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0a62fa1-9f8a-4770-b28b-1f4f02a762e0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69256-337-06Mucus Relief Severe Congestion and CoughMaximum Strength177 mL in 1 BOTTLE, PLASTICLIQUID1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-337MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [HARRIS TEETER, LLC]2Current NDC, Legacy NDC, 1 package rows20231011_e0a62fa1-9f8a-4770-b28b-1f4f02a762e0.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 165 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dimetapp Cough and AllergyDIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare15b0f5ff-202a-d19f-e063-6394a90af2b82024-04-15WarningsExact identifier
application number: M012
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLP & L Development, LLC8d27b94d-23a1-4e6c-a064-79e2580f7e2e2024-04-15WarningsExact identifier
application number: M012
Severe Cold and Cough Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLP & L Development, LLC2af496a1-6fdd-4acf-9944-8b7cdf3022752024-04-15WarningsExact identifier
application number: M012
Childrens Dye Free AllergyDIPHENHYDRAMINE HYDROCHLORIDEP & L Development, LLC1c4d09ed-4e0f-430d-b17f-6a23f996a55d2024-04-15WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC9736ad4c-8c2e-421f-b023-f91b72d2828b2024-04-10WarningsExact identifier
application number: M012
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCLHaleon US Holdings LLCb06b64c5-dbb4-4ef5-af18-3d7d4979c02f2024-04-10WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATEHarris Teeter, LLCec603195-eb36-4b5c-bc9b-c2074205b2b22024-04-09WarningsExact identifier
application number: M012
Daytime Cold and Flu Non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLC9b0648ac-0ce3-4eaa-8977-26ae864f034d2024-04-09WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLHaleon US Holdings LLCf147d82e-4429-4c7b-bd2b-e21a09f21c922024-04-09WarningsExact identifier
application number: M012
FLONASE Headache and Allergy ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLHaleon US Holdings LLC282c103c-3888-4a35-a5b1-d492ed6892c12024-04-08WarningsExact identifier
application number: M012
ROBITUSSIN COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC4908b326-e1da-44ca-8087-7e41a16c27b02024-04-08WarningsExact identifier
application number: M012
Robitussin Direct Sore Throat PainACETAMINOPHENHaleon US Holdings LLC1b512078-24c3-4b80-8f2c-d6824d367f252024-04-08WarningsExact identifier
application number: M012
Mucus Relief Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENSINH E B9ba5ca1b-2e3c-439e-8887-c26f144b88ef2024-04-08WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E B12ace982-bd47-49b0-ba1b-e0a29d42f1d62024-04-08WarningsExact identifier
application number: M012
Allergy ChildrensDIPHENHYDRAMINE HYDROCHLORIDEH E Bab28cbc4-7a6f-46e9-8616-be78e8cb24fe2024-04-08WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E Bbd19b1f2-d9d3-4dab-8181-605f769ab62f2024-04-08WarningsExact identifier
application number: M012
Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E B9f533092-060c-4379-9a77-ecfea8aa46e12024-04-08WarningsExact identifier
application number: M012
Robitussin Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC66360295-f364-479a-8b49-c12b219182792024-04-06WarningsExact identifier
application number: M012
Robitussin Peak Cold Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC8c0a2424-e8ac-d91c-b46d-a5ee29f919362024-04-06WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEHaleon US Holdings LLCe7cf7c5d-5c9a-4201-9e30-1cd6160718552024-04-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNe0a62fa1-9f8a-4770-b28b-1f4f02a762e03
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDe0a62fa1-9f8a-4770-b28b-1f4f02a762e03
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYe0a62fa1-9f8a-4770-b28b-1f4f02a762e03
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYe0a62fa1-9f8a-4770-b28b-1f4f02a762e03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69256-337-0669256033706177 mL in 1 BOTTLE, PLASTIC (69256-337-06) 177 ml2021-05-282027-05-28NoNoCurrent