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 43 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MGC HealthCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f3f6dd-751d-1dfe-e063-6394a90a0dbb2026-03-25WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS MENTHOL SUGAR-FREEMedical Group Care LLCf4a90af2-47af-ac8c-e053-2a95a90ab97e2026-03-25WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS BLACK CHERRY SUGAR FREEMedical Group Care LLC043b3639-ab38-adff-e063-6394a90a2ade2026-03-25WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATEWinCo Foods, LLC4535fa03-64ac-4ec6-9d0c-b372bb12773b2026-03-25WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED3e73a5f7-5976-4839-9705-c1730ff6bf302026-03-25WarningsExact identifier
application number: M012
GOOD SENSE TUSSINACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Company5fb96638-a9bc-4be6-a624-da303a9e98a32026-03-25WarningsExact identifier
application number: M012
Cold and Flu Relief Multi symptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC9beeeb3b-6b26-4b9a-843b-ce3658d1debe2026-03-25WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefNIGHTTIME COLD AND FLU RELIEFGrocery Outleta58459e3-6ada-4d99-9e22-1a01076761512026-03-25WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MGGrocery Outlet2f90dfb6-4257-44a8-a685-1873645d1c962026-03-25WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.4d887ed0-4532-5125-e063-6394a90ac44d2026-03-24WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS HEALTH CORP2ba90b91-2e35-4701-e063-6294a90a75542026-03-24WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESIN 400 MGTWIN MED LLCe31bd69f-97ab-9d99-e053-2995a90a580e2026-03-24WarningsExact identifier
application number: M012
Severe Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLCb7b1c3cc-fdf3-4e75-8c3f-2e832f09a8872026-03-24WarningsExact identifier
application number: M012
Nuvicare Long-Acting Cough ReliefDEXTROMETHORPHAN HYDROBROMIDENUVICARE LLCec1d3dd6-2a8b-4487-81a2-be6313e976102026-03-24WarningsExact identifier
application number: M012
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCed28bfa9-3768-4f42-ae5e-1c527b4456d12026-03-24WarningsExact identifier
application number: M012
Gencare Long-Acting Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEPIONEER LIFE SCIENCES, LLC7a02cbb6-c083-4d91-977b-9d53cb3e27842026-03-24WarningsExact identifier
application number: M012
Sinus Severe DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCb65baa7c-8197-4361-b3ef-e60eba38dca12026-03-24WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreense9a53a2c-c5e8-48ba-97d9-c1e3cbd8da4b2026-03-24WarningsExact identifier
application number: M012
Mucus Relief Congestion and Headache Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2638b541-e680-4949-a7c7-fcee165cbc922026-03-23WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)778dc0fb-30c3-4fbf-856a-7bca28181b392026-03-23WarningsExact 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