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 133 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola Agb790a91c-33be-4bc3-bdeb-eae6f366f0852024-12-05WarningsExact identifier
application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANTMENTHOLRicola Agea42e516-2ef8-41c9-ae4e-571f0147bc6b2024-12-05WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE SWISS CHERRYMENTHOLRicola Ag8b2d5c0f-509e-447d-b071-d73c4785f1202024-12-05WarningsExact identifier
application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola Ag8ae0e21a-44a0-4a2c-9880-54eeeaea07ea2024-12-05WarningsExact identifier
application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag6d82469b-d51c-4824-9830-6c1874ad4fe42024-12-05WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINTMENTHOLRicola Age8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce52024-12-05WarningsExact identifier
application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Aga535717d-ba55-45e9-9fc3-711b5d7dbf572024-12-05WarningsExact identifier
application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPSMENTHOLRicola Ag4330ee8d-0b37-4a93-886b-5fc6e6598da72024-12-05WarningsExact identifier
application number: M012
COLD AND FLU DAYTIME SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORP9de99931-31ef-79e2-e053-2a95a90a98ad2024-12-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC3ef6d155-b95b-4b30-87a8-8ed811b1520f2024-12-03WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDETOPCAREa1b2b16d-c767-2945-e053-2995a90a48342024-12-03WarningsExact identifier
application number: M012
Sinus Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETopCarefa9b2748-0474-4a39-a2b8-bb6f0678c1d12024-12-03WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCa9640e09-369c-3c55-e053-2a95a90aebd52024-12-03WarningsExact identifier
application number: M012
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCec7e5e2e-23c7-32ae-e053-2995a90a12512024-12-03WarningsExact identifier
application number: M012
COLD AND FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREcbb179c8-31fb-4a3a-9f23-4024350f8b7f2024-12-03WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCa96431a0-b05d-4812-e053-2a95a90a5af62024-12-03WarningsExact identifier
application number: M012
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLCaa0d6762-b803-4630-8f74-780b7ea9acff2024-12-03WarningsExact identifier
application number: M012
Cold plus Head CongestionACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCec7e5e2e-23c5-32ae-e053-2995a90a12512024-12-03WarningsExact identifier
application number: M012
Cold Plus Head Congestion Day and NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC898eb1c7-395a-4845-9d0a-719fc78d86b72024-12-03WarningsExact identifier
application number: M012
Cold Plus Head Congestion NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC7854c1fd-b5fc-477d-a79e-ff006ebf6fe52024-12-03WarningsExact 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