FDA.reportPublic FDA data

NDC 61841-403 - Tussin Guifenesin Expectrorant Syrup

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
61841-403
Package NDCs from labels
61841-403-26
Manufacturer
Bayer HealthCare LLC | Bio-Pharm, Inc.
Effective date
2015-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tussin Guifenesin Expectrorant Syrup - Bayer HealthCare LLC | Bio-Pharm, Inc.Bayer HealthCare LLC | Bio-Pharm, Inc.2015-01-14HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61841-403-262020-01-31C16284748780-19d75b9d0-2c83-f424-e053-dadaa90a57ceTussin-Export Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61841-403-26TussinGuifenesin Expectrorant Syrup118 mL in 1 BOTTLE, PLASTICSYRUP1181
61841-403-26TussinGuifenesin Expectrorant Syrup1 in 1 CARTONSYRUP11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61841-403TUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]12 package rows20150115_0ca25fb1-c9b6-481d-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]1
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NTUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]1
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ATUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]1

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 152 of 207 · 4,122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cherry Throat DropsMENTHOLRicola Ag73d767e2-bb80-4eff-8420-500c2a4067aa2024-12-05WarningsExact identifier
unii: L7T10EIP3A
COOL RELIEF ORAL ANESTHETICMENTHOLRicola Ag951e9836-e6a3-4094-8a6b-f226c85c897a2024-12-05WarningsExact identifier
unii: L7T10EIP3A
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag6d82469b-d51c-4824-9830-6c1874ad4fe42024-12-05WarningsExact identifier
unii: L7T10EIP3A
RICOLA MAX THROAT CARE COOL PEPPERMINTMENTHOLRicola Age8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce52024-12-05WarningsExact identifier
unii: L7T10EIP3A
COOL RELIEF LEMON FROST ORAL ANESTHETICMENTHOLRicola Ag908f5ce5-94a4-4c35-ae7a-b308ea37fa082024-12-05WarningsExact identifier
unii: L7T10EIP3A
ORGANIC PEPPERMINT HERB THROAT DROPSMENTHOLRicola Aga6657ecf-e74a-4912-a68c-73abc456f9e22024-12-05WarningsExact identifier
unii: L7T10EIP3A
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Aga535717d-ba55-45e9-9fc3-711b5d7dbf572024-12-05WarningsExact identifier
unii: L7T10EIP3A
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola Ag67373cf1-e8c3-4db2-98e1-c88d25a762092024-12-05WarningsExact identifier
unii: L7T10EIP3A
Natural Cherry Honey Herb Throat DropsMENTHOLRicola Ag586b2a46-2673-4f27-a62a-2d48a9b520ab2024-12-05WarningsExact identifier
unii: L7T10EIP3A
BERRY MEDLEY THROAT DROPSMENTHOLRicola Aga2bdd035-4678-4cff-b24f-8e2f06acad962024-12-05WarningsExact identifier
unii: L7T10EIP3A
THE ORIGINAL NATURAL HERB COUGH DROPSMENTHOLRicola Ag4330ee8d-0b37-4a93-886b-5fc6e6598da72024-12-05WarningsExact identifier
unii: L7T10EIP3A
CVS Health Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATENatural Essentials, Inc.f7198485-3d68-41d2-b9b9-f932a06493102024-12-04WarningsExact identifier
unii: L7T10EIP3A
COLD AND FLU DAYTIME SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORP9de99931-31ef-79e2-e053-2a95a90a98ad2024-12-04WarningsExact identifier
unii: 495W7451VQ
Sinus Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETopCarefa9b2748-0474-4a39-a2b8-bb6f0678c1d12024-12-03WarningsExact identifier
unii: 495W7451VQ
COLD AND FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREcbb179c8-31fb-4a3a-9f23-4024350f8b7f2024-12-03WarningsExact identifier
unii: 495W7451VQ
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLCe07d880b-a12a-4e5e-94c0-bd36bcfe738c2024-12-03WarningsExact identifier
unii: 495W7451VQ
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREbd0a3679-1f7c-4c41-e053-2995a90a8fcb2024-12-03WarningsExact identifier
unii: 495W7451VQ
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCbd09e4f3-3211-8c08-e053-2a95a90a73f92024-12-03WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cold and Flu All In OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREa1b281ec-fd42-963c-e053-2a95a90a4b712024-12-03WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCb3366ad4-5ef4-eb70-e053-2995a90acf332024-12-03WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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