FDA.reportPublic FDA data

G-ZYNCOF

Product NDC
52083-600
11-digit product format
520830600
Labeler code
52083
Product ID
52083-600_a7c507ab-f326-4890-b26d-d80c59cacf8a
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Guaifenesin
Dosage form
SYRUP
Route
ORAL
Labeler
Kramer Novis
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-12-03
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/5mL; mg/5mL
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
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
G-ZYNCOF
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1113368Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1aa7060-0f32-4ea1-8e2e-1aa131bd55fcAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-600-16G-ZYNCOF473 mL in 1 BOTTLE, PLASTICSYRUP4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-600-16ML - Milliliter52083-600edeaf9ed-dd8b-4828-abfe-35d4869c739412013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHG-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
GUAIFENESINACTIVE INGREDIENT495W7451VQG-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSG-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
GUAIFENESINACTIVE MOIETY495W7451VQG-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPG-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AG-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TG-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L4G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHG-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRG-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1
WATERINACTIVE INGREDIENT059QF0KO0RG-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-600G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]4Current NDC, Legacy NDC, 1 package rows20241012_c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc.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 167 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCb9772292-9eb6-47cf-abb8-007c254780902024-03-17WarningsExact identifier
application number: M012
Childrens Robitussin Cough Long-ActingDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC75bc7827-4439-e6a8-a65c-7154d5592e582024-03-17WarningsExact identifier
application number: M012
Childrens Robitussin Nighttime Cough Long-Acting DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c2024-03-17WarningsExact identifier
application number: M012
ANTIGRIP DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLC12f20aba-f991-bd82-e063-6294a90a4aac2024-03-16WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWALGREENSd3053f80-aece-eb50-e053-2a95a90a59452024-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCLWALGREENSd315bc95-1b46-75df-e053-2a95a90a6c662024-03-15WarningsExact identifier
application number: M012
MAR-COF CG ExpectorantCODEINE PHOSPHATE AND GUAIFENESINMarnel Pharmaceuticals, LLC60a41229-b125-43d8-b2b4-0bf40feed7642024-03-15WarningsExact identifier
application number: M012
Night Time CoughDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INC97aa0b90-1230-4143-b5d3-18b96a6b7b4f2024-03-15WarningsExact identifier
application number: M012
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLC036162c9-f5a6-418e-bd5e-ebd72097d27d2024-03-15WarningsExact identifier
application number: M012
Bronkaid MaxEPHEDRINE SULFATEFoundation Consumer Healthcare LLC9a0b792a-caee-41f6-9400-922a5ebd592f2024-03-14WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutions5f2b16f0-c58b-4e48-ad92-eaab93c6c4b22024-03-12WarningsExact identifier
application number: M012
Coricidin HBP Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDEA-S Medication Solutionsffcae882-0b19-4219-bbee-a175c63d79c82024-03-11WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime with Honey Ginger FlavorACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC18dcede2-5a38-40fa-93fe-48acdd6a7cf12024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Nighttime with Honey Elderberry FlavorACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLCd4ce06aa-776f-45e4-a1a6-9cf13797048f2024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC14e38ef0-a5e7-4df7-824f-f27bef664d252024-03-08WarningsExact identifier
application number: M012
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC68d3e88a-d1be-410b-92a1-863903b3aa612024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC0d3b1bea-e2ca-4e07-8ae5-60627d230c962024-03-08WarningsExact identifier
application number: M012
Theraflu PowerPods Daytime Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEHaleon US Holdings LLCe655c33c-c319-41d9-ae55-cf747242cd102024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime Berry BurstACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLCadf33520-4689-4de2-b9d8-c201518e9d262024-03-08WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCf6ae9e3a-6bea-40e0-8a6f-45f4be8319e72024-03-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113368dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral SolutionPSNc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc5
1113368dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral SolutionSCDc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc5
1113368dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral SolutionSYc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc5
1113368dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML SyrupSYc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-600-1652083060016473 mL in 1 BOTTLE, PLASTIC (52083-600-16) 473 ml2012-12-030000-00-00NoNoCurrent