Tussin Expectorant

Product NDC
76281-507
11-digit product format
762810507
Labeler code
76281
Product ID
76281-507_46e2f5c3-5d72-c4d3-e063-6294a90a74a0
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
AptaPharma, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-30
Substance
GUAIFENESIN
Active strength
100 mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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
Tussin Expectorant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310604Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca8fa216-09c1-42b2-a95b-fa3d0f13363cAvailable 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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-507-24Tussin Expectorant118 mL in 1 BOTTLELIQUID1185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-507TUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [APTAPHARMA, INC.]4Current NDC, Legacy NDC, 1 package rows20231231_ca8fa216-09c1-42b2-a95b-fa3d0f13363c.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 131 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINEBest Choice (Valu Merchandisers Company)539b8972-2a46-468e-ad27-6672d746feb72024-12-10WarningsExact identifier
application number: M012
DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.db2ab9be-507d-4768-9d00-188f751b77262024-12-10WarningsExact identifier
application number: M012
Adult Allergy ReliefCALMCO ALLERGY RELIEFCalmCo08288825-0f38-b6a3-e063-6394a90aa3582024-12-07WarningsExact identifier
application number: M012
Original Herb Cough DropsMENTHOLRicola Agc142663f-086e-4ab7-a758-9107d70775372024-12-05WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag984c9793-163c-4b97-b244-9b471966a1222024-12-05WarningsExact identifier
application number: M012
BENZEDREXPROPYLHEXEDRINEBF ASCHER AND CO INC00d8c237-3eee-1d9f-e063-6394a90aeb862024-12-05WarningsExact identifier
application number: M012
Cold Multi Symptom Daytime NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Associationd5cbb5b0-564c-429e-b680-fa683e7963932024-12-05WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCarede8a623f-7b10-4d56-a74b-3737e7716ffe2024-12-05WarningsExact identifier
application number: M012
Cold Max DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC9773958b-c5e5-4da7-a8e9-6b6c223a2b302024-12-05WarningsExact identifier
application number: M012
Cold Plus Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC399e0e51-c2a7-451c-b74d-d3db140cef692024-12-05WarningsExact identifier
application number: M012
Head Congestion Plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI09531edc-8dbd-451f-ae02-f922e9e8c2482024-12-05WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag71ca8af7-172d-40da-be1e-ff3ab5568e742024-12-05WarningsExact identifier
application number: M012
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSNca8fa216-09c1-42b2-a95b-fa3d0f13363c5
310604guaifenesin 20 MG/ML Oral SolutionSCDca8fa216-09c1-42b2-a95b-fa3d0f13363c5
310604guaifenesin 100 MG per 5 ML Oral SolutionSYca8fa216-09c1-42b2-a95b-fa3d0f13363c5
310604guaifenesin 100 MG per 5 ML Oral SyrupSYca8fa216-09c1-42b2-a95b-fa3d0f13363c5
310604guaifenesin 200 MG per 10 ML Oral SolutionSYca8fa216-09c1-42b2-a95b-fa3d0f13363c5
310604guaifenesin 300 MG per 15 ML Oral SolutionSYca8fa216-09c1-42b2-a95b-fa3d0f13363c5
310604guaifenesin 400 MG per 20 ML Oral SolutionSYca8fa216-09c1-42b2-a95b-fa3d0f13363c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76281-507-2476281050724118 mL in 1 BOTTLE (76281-507-24) 118 ml2020-09-300000-00-00NoNoCurrent