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 111 of 207 · 4,122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f67ac3d-1503-3418-e063-6394a90a938f2025-09-22WarningsExact identifier
unii: 495W7451VQ
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories Inc.3f68e68a-cf32-9df8-e063-6394a90a30122025-09-22WarningsExact identifier
unii: 495W7451VQ
TheraCare Roll-on Menthol 16% Pain Relief LiquidMENTHOLVeridian Healthcared932050d-2a9a-4a5e-b45d-0a7a864582e02025-09-22WarningsExact identifier
unii: L7T10EIP3A
TheraCare Roll-on Menthol 4% Pain ReliefMENTHOLVeridian Healthcarefa121e5f-94b5-4c1d-9c4e-85bb8ede39452025-09-22WarningsExact identifier
unii: L7T10EIP3A
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.c6392ace-c7d1-4450-8b71-4dccc60b4f022025-09-22WarningsExact identifier
unii: 495W7451VQ
Guaifenesin 1200 mgGUAIFENESINDr. Reddy's Laboratories Inc.525fda90-134c-f038-c403-eb5ffc1fb1f12025-09-22WarningsExact identifier
unii: 495W7451VQ
UP AND UP MUCUS RELIEFGUAIFENESINTarget Corporation059cff23-b6a5-40dc-ac4e-9bcb552e97642025-09-22WarningsExact identifier
unii: 495W7451VQ
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f12ee8f-d1c6-d73a-e063-6394a90a91992025-09-18WarningsExact identifier
unii: 495W7451VQ
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f025ef6-79e7-e833-e063-6294a90ab5012025-09-17WarningsExact identifier
unii: 495W7451VQ
AXIV Sinus Severe MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDEVIVUNT PHARMA LLC13245298-8b78-e177-e063-6294a90a6bec2025-09-17WarningsExact identifier
unii: 495W7451VQ
GoodSense Tussin CF Multi-Symptom Cold, RaspberryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.3f05cf84-d485-7688-e063-6394a90ae7402025-09-17WarningsExact identifier
unii: 495W7451VQ
MedFreeze Naturally Cool Pain ReliefMENTHOLMEDKO LLC240f2346-c585-4334-997c-45db6268d7c42025-09-15WarningsExact identifier
unii: L7T10EIP3A
MEDISTIK DUAL HOT AND COLDMETHYL SALICYLATE, MENTHOLNatureteq Inc.ba5f4626-f077-4a28-8dcc-dacd50741ead2025-09-15WarningsExact identifier
unii: L7T10EIP3A
MEDISTIK ICEMENTHOL, CAMPHORNatureteq Inc.c1077744-7b9a-4536-8faf-e21994a43ea52025-09-15WarningsExact identifier
unii: L7T10EIP3A
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh RelievaCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.6b984fa2-4187-45ef-b7d3-15e720abc6672025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3ea9a1f2-75b3-c67a-e063-6294a90a8caf2025-09-13WarningsExact identifier
unii: L7T10EIP3A
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3eab4cf9-6fdc-a6fb-e063-6394a90a86332025-09-13WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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