Mucus Relief Xpect

Product NDC
58596-003
11-digit product format
585960003
Labeler code
58596
Product ID
58596-003_eb0096fe-dcf6-2ac6-e053-2a95a90aa8a1
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifensin, Dextromethorphan
Dosage form
TABLET
Route
ORAL
Labeler
Selgel M
Application
M012
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-05-17
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/1; mg/1
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
2023-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 156 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu Relief Multi Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWinCo Foods, LLC5791c1c7-f614-4940-a45a-6291742e1e222024-09-17WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafeway2affd44d-2125-4a1f-919c-c082e7644ea82024-09-17WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSYACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINEAdvanced Rx LLCfa1a4d86-87bb-0c50-e053-6394a90a56e22024-09-13WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOMACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAdvanced Rx LLCfa1b60b1-49cb-1211-e053-6394a90a0a462024-09-13WarningsExact identifier
application number: M012
nasalPHENYLEPHRINE HYDROCHLORIDEWalgreen Company8db7df1c-46b5-49bd-9002-50b12d58001a2024-09-13WarningsExact identifier
application number: M012
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.1bdd7f8a-93ce-5309-e063-6294a90a91f02024-09-12WarningsExact identifier
application number: M012
oxymetazoline hclOXYMETAZOLINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltda1103cd8-344b-4a65-8a60-3c7be86d01a62024-09-11WarningsExact identifier
application number: M012
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDEL. Perrigo Company276d7d3c-c4a7-4754-8845-c38f85aac5f72024-09-08WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDEStrategic Sourcing Services LLC4ff5a4ae-9649-4a6d-a5f8-ca23efbbb4792024-09-08WarningsExact identifier
application number: M012
equate nasal originalOXYMETAZOLINE HYDROCHLORIDEWal-Mart Stores Inc7e40c9b8-e0b5-448a-a674-72388fbab1892024-09-08WarningsExact identifier
application number: M012
Anefrin Nasal OriginalOXYMETAZOLINE HYDROCHLORIDEWalgreen Company85b442dc-1703-4fef-948a-fad7cbe9f2242024-09-07WarningsExact identifier
application number: M012
equaline nasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI07e0328e-1912-4f25-9e1e-9482d4665be02024-09-07WarningsExact identifier
application number: M012
Benadryl Allergy EXTRA STRENGTHDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCdd0a8069-18d8-5696-e053-2995a90a2f222024-09-06WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEPAI Holdings, LLC88d0994c-4270-4408-8837-bd97510b21182024-09-06WarningsExact identifier
application number: M012
QCH Maximum Strength Mucus Relief 617DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association Inc.a1c5c15e-0f3a-47d3-b9ed-1e00184175142024-09-06WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Nighttime Soft ChewsACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC6ba64bbe-7599-406a-9187-737c0f8c1c2a2024-09-05WarningsExact identifier
application number: M012
Cough Relief NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)344282fc-3bd1-4f49-9bd1-08c5a58d1f732024-09-05WarningsExact identifier
application number: M012
Equate NasalPHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc95ef1819-edc3-4dda-8514-85b61538cc722024-09-04WarningsExact identifier
application number: M012
Up and up nasalOXYMETAZOLINE HYDROCHLORIDETarget Corporation0c246c11-eadd-4ac6-bd58-5fdb151e06d62024-09-04WarningsExact identifier
application number: M012
Exchange Select NasalOXYMETAZOLINE HYDROCHLORIDEArmy & Air Force Exchange Serviceaafa9163-f08e-48c9-9ca1-7b72f67d007d2024-08-31WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58596-003-20585960003202 BLISTER PACK in 1 CARTON (58596-003-20) > 10 TABLET in 1 BLISTER PACK2 blister pack2021-05-190000-00-00NoNoCurrent
58596-003-30585960003303 BLISTER PACK in 1 CARTON (58596-003-30) > 10 TABLET in 1 BLISTER PACK3 blister pack2021-05-190000-00-00NoNoCurrent