FDA.reportPublic FDA data

TUSICOF

Product NDC
52083-239
11-digit product format
520830239
Labeler code
52083
Product ID
52083-239_e954ebb2-df25-40bf-b068-8ac861d6677b
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan, guaifenesin, and phenylephrine
Dosage form
SYRUP
Route
ORAL
Labeler
Kramer Novis
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-08-17
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20; 400; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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
TUSICOF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/5mL
GUAIFENESIN400 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091331Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e966b75c-4bb4-4216-8247-baada8f5d759Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-239-01TUSICOF30 mL in 1 BOTTLESYRUP307
52083-239-04TUSICOF120 mL in 1 BOTTLESYRUP1207
52083-239-16TUSICOF474 mL in 1 BOTTLESYRUP4747

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-239-04ML - Milliliter52083-239b715ea09-053c-42b6-ba32-08b9368055d412012-07-24
52083-239-16ML - Milliliter52083-23938e2d9a5-bfde-4e35-90a8-1c6f4175a09012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
GUAIFENESINACTIVE MOIETY495W7451VQTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3
WATERINACTIVE INGREDIENT059QF0KO0RTUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-239TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]6Current NDC, Legacy NDC, 3 package rows20241011_e966b75c-4bb4-4216-8247-baada8f5d759.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 146 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.d3bd0632-328c-4ad7-bb44-8383e1e51b8c2024-10-28WarningsExact identifier
application number: M012
Premier ValueDEXTROMETHORPHAN HBR, GUAIFENESINPHARMACY VALUE ALLIANCE LLC1ae3c6ac-1646-4c67-a9d5-9c383924b81a2024-10-28WarningsExact identifier
application number: M012
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy1c341cf5-ac33-4a6e-b023-a23d280d496c2024-10-25WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companyb6d9f421-b236-4660-be7f-85a878f2fc612024-10-25WarningsExact identifier
application number: M012
COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEFACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEChain Drug Consortium, LLCf9c3c12b-4efa-4ec4-a156-c403aff817532024-10-24WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEChain Drug Consortium, LLC1deb60f3-e9be-4756-b0c1-527ef00dc7412024-10-24WarningsExact identifier
application number: M012
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.51dd467b-aae8-41fa-e054-00144ff8d46c2024-10-24WarningsExact identifier
application number: M012
Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC68a5930b-37db-439d-8fb9-7d7de07d84652024-10-24WarningsExact identifier
application number: M012
sinus pressure pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INCbb0225d5-6c32-2c64-e053-2995a90a829b2024-10-24WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC01e1ad15-0ef5-4d6a-a9c1-19a5f2b201482024-10-24WarningsExact identifier
application number: M012
CareOne Fast Acting NasalPHENYLEPHRINE HYDROCHLORIDEAmerican Sales Company95b22dce-ef54-4ab5-9cc3-0e1cefa09ec52024-10-24WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Consortium, LLC8cb0d0c8-c565-4c5a-97c5-8250a67e23a82024-10-24WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc0d07a534-c67f-4041-a07c-ed7f68dfc4262024-10-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.90977b39-8ced-46bf-9d06-15306bce9b352024-10-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb2024-10-23WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e2325f33-e4e4-1269-e053-2995a90ab4ac2024-10-23WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.a8240d98-f0b0-3ded-e053-2a95a90a5cf92024-10-23WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.a82401f5-65b1-11e9-e053-2a95a90a499e2024-10-23WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.a823db21-4863-45a6-e053-2995a90ab8e62024-10-23WarningsExact identifier
application number: M012
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e2346d0c-75cf-974c-e053-2a95a90a28572024-10-23WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091331dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSNe966b75c-4bb4-4216-8247-baada8f5d7597
1091331dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCDe966b75c-4bb4-4216-8247-baada8f5d7597
1091331dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSYe966b75c-4bb4-4216-8247-baada8f5d7597

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-239-015208302390130 mL in 1 BOTTLE (52083-239-01) 30 ml2010-08-170000-00-00NoNoCurrent
52083-239-0452083023904120 mL in 1 BOTTLE (52083-239-04) 120 ml2010-08-170000-00-00NoNoCurrent
52083-239-1652083023916474 mL in 1 BOTTLE (52083-239-16) 474 ml2012-10-080000-00-00NoNoCurrent