FDA.reportPublic FDA data

Mucus Relief D

Product NDC
41250-547
11-digit product format
412500547
Labeler code
41250
Product ID
41250-547_3d0fda6a-9c23-4968-843c-a8c1f561ff67
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-26
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
400; 40 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
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
Mucus Relief D
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1090623Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
383281d7-0d25-4423-ace2-d2985f2c37d0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-547-72Mucus Relief D9 in 1 BLISTER PACKTABLET, FILM COATED913
41250-547-72Mucus Relief D3 in 1 CARTONTABLET, FILM COATED313

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NMUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FMUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EMUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-547MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]12Current NDC, Legacy NDC, 2 package rows20240830_383281d7-0d25-4423-ace2-d2985f2c37d0.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 161 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETARGET CORPORATION135d2212-2122-b7a1-e063-6294a90aa5f52024-06-07WarningsExact identifier
application number: M012
up and up daytime honey cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETarget Corporation29da4b94-8f8e-48e8-909f-8476e3b39d782024-06-06WarningsExact identifier
application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCITARGET Corporatione3da3003-88e3-4431-8b65-e61e177289012024-06-04WarningsExact identifier
application number: M012
Dimetapp Cold and AllergyBROMPHENIRAMINE MALEATEFoundation Consumer Healthcare15c3570c-bd00-8e43-e063-6294a90a86832024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Healthcare176be362-5237-edd8-e063-6294a90a4aef2024-06-01WarningsExact identifier
application number: M012
Dimetapp Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare179115ad-d610-99b2-e063-6294a90ae7112024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Healthcare179259a9-231e-df03-e063-6294a90a145e2024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and CoughBROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDEFoundation Consumer Healthcare1820e7c7-bc11-9061-e063-6394a90ae5812024-06-01WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLHaleon US Holdings LLC682c5a4b-5ded-4276-903f-1ef1141ae5182024-06-01WarningsExact identifier
application number: M012
Maximum Strength Nasal DecongestantOXYMETAZOLINE SPRAYCVS Healthdf1f8bda-7bf3-4755-9169-f2a81d824cbe2024-05-31WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYCVS Healtha78d29ed-019b-4014-ae6f-c60c75d19c892024-05-31WarningsExact identifier
application number: M012
Leader Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDECardinal Health 110,Inc6594c117-6ffc-4bda-8bbf-e91c810f2c3f2024-05-31WarningsExact identifier
application number: M012
Nighttime Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI1aba9b7c-8328-4a9f-8ce2-39648b2d8ae42024-05-23WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIfdf63308-fe7b-4613-a012-ed5e4c9f8ffe2024-05-23WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIe61ab02d-f932-403f-a4f7-0ca3546072232024-05-23WarningsExact identifier
application number: M012
Daytime Cold and Flu Relief Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIe4f9a846-ab72-4508-b0c5-f7911af2f3d72024-05-23WarningsExact identifier
application number: M012
Adult Cough ReliefDEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c2024-05-20WarningsExact identifier
application number: M012
Chlorpheniramine Maleate 4 mgCHLORPHENIRAMINE MALEATEBryant Ranch Prepack54681242-c861-4415-b5c0-d3ab55b62be12024-05-17WarningsExact identifier
application number: M012
Dibromm Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)c830b18b-4427-4530-9bc7-85c2735080d22024-05-17WarningsExact identifier
application number: M012
Childrens Cold and Cough NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLSafeway, Inc.cbbec807-f882-4c6a-b1cd-c7fd5ce70cad2024-05-15WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090623guaiFENesin 400 MG / pseudoephedrine HCl 40 MG Oral TabletPSN383281d7-0d25-4423-ace2-d2985f2c37d013
1090623guaifenesin 400 MG / pseudoephedrine hydrochloride 40 MG Oral TabletSCD383281d7-0d25-4423-ace2-d2985f2c37d013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-547-72412500547723 BLISTER PACK in 1 CARTON (41250-547-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2007-01-260000-00-00NoNoCurrent