FDA.reportPublic FDA data

ZYNCOF

Product NDC
52083-400
11-digit product format
520830400
Labeler code
52083
Product ID
52083-400_7e831d13-64c5-4ee2-a290-d1d93ceec80f
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
2011-06-01
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
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
cffd6d5f-0cb2-4d38-bdb0-6a21120418ccAvailable 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
52083-400-01ZYNCOF30 mL in 1 BOTTLE, PLASTICSYRUP306
52083-400-04ZYNCOF120 mL in 1 BOTTLE, PLASTICSYRUP1206
52083-400-16ZYNCOF474 mL in 1 BOTTLE, PLASTICSYRUP4746

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-400-01ML - Milliliter52083-400f9c657ae-aa72-410c-a3a1-3a2b10c2a7b012017-04-05
52083-400-04ML - Milliliter52083-400601296d5-d808-4845-a5be-af602f497ea012012-07-24
52083-400-16ML - Milliliter52083-400845a08ee-89d4-4d5a-9ff6-03c1e02384b812013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
GUAIFENESINACTIVE INGREDIENT495W7451VQZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
GUAIFENESINACTIVE MOIETY495W7451VQZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
MENTHOLINACTIVE INGREDIENTL7T10EIP3AZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L4ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3
WATERINACTIVE INGREDIENT059QF0KO0RZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-400ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]5Current NDC, Legacy NDC, 3 package rows20241012_cffd6d5f-0cb2-4d38-bdb0-6a21120418cc.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 123 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEMeijer, Inc.df31056b-d0eb-4094-98d9-3d444210d50d2025-01-16WarningsExact identifier
application number: M012
Childrens Ibuprofen Oral SuspensionIBUPROFENReliable 1 Laboratories LLC28dd9baa-43bd-b60a-e063-6394a90a8cf72025-01-15WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINReliable 1 Laboratories LLCae469d4f-91c4-cff0-e053-2995a90a04972025-01-15WarningsExact identifier
application number: M012
Diphenhydramine HCL 25 mgDIPHENHYDRAMINE HCLReliable 1 Laboratories LLC32f58cb3-941f-263b-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M012
Diphenhydramine HCl 25 mgDIPHENHYDRAMINE HCLReliable 1 Laboratories LLC32fa40ad-fed5-586f-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M012
CVS Health Chest Congestion and Cough HBP SOFTGELDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS Pharmacy, Inc2741ba44-1cc7-1812-e063-6394a90a8faa2025-01-14WarningsExact identifier
application number: M012
DAY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORPORATION2b941963-8a8c-4148-e063-6294a90a1dfb2025-01-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.437e6a13-a4ff-4f98-8973-042f224ee85e2025-01-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.6a520986-1004-4ee6-9a47-1dfd90bb1b2c2025-01-13WarningsExact identifier
application number: M012
good sense daytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company5ddf3283-94e4-465d-842a-471ee946c3302025-01-10WarningsExact identifier
application number: M012
Vicks VapoSteamCAMPHOR (SYNTHETIC)Kaz USA, Incc28da455-07ad-4053-8b9e-fc559f9a3f722025-01-10WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINAphena Pharma Solutions - Tennessee, LLC45ac210a-8c54-4469-8e10-e6fe52b89cb52025-01-09WarningsExact identifier
application number: M012
Meclizine HCLMECLIZINE HCL 25MG CHEWABLE TABLETSAphena Pharma Solutions - Tennessee, LLC02d1af4d-d97d-4019-a5bf-3ec3912386762025-01-09WarningsExact identifier
application number: M012
HISTEX PD Drops New FormulationTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC0c693f15-5d76-3dbf-e063-6294a90af9ac2025-01-08WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HBR 15 MGDEXTROMETHORPHAN HBR 15 MGAMZ789 LLCe2175017-6a0d-0155-e053-2995a90a65d62025-01-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealth Pharma USA LLC29bb7822-76c6-e39d-e063-6294a90a64fb2025-01-07WarningsExact identifier
application number: M012
Childrens Allergy ReliefCHILDRENS ALLERGY RELIEFAllegiant Healthcb6df361-b8e5-4e2f-945f-c20159d76c4f2025-01-06WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLWinCo Foods, LLCbb7a9fed-dc04-4c31-aa7f-4185d955242c2025-01-06WarningsExact identifier
application number: M012
Leader Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leader207b2677-aaad-4fe4-a96d-963b7dcfba702025-01-06WarningsExact identifier
application number: M012
Allergy Relief CapletDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC126c05e7-2cd9-47d3-96c3-82305714e1db2025-01-02WarningsExact 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 SolutionPSNcffd6d5f-0cb2-4d38-bdb0-6a21120418cc6
1113368dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral SolutionSCDcffd6d5f-0cb2-4d38-bdb0-6a21120418cc6
1113368dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral SolutionSYcffd6d5f-0cb2-4d38-bdb0-6a21120418cc6
1113368dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML SyrupSYcffd6d5f-0cb2-4d38-bdb0-6a21120418cc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-400-015208304000130 mL in 1 BOTTLE, PLASTIC (52083-400-01) 30 ml2011-06-010000-00-00NoNoCurrent
52083-400-0452083040004120 mL in 1 BOTTLE, PLASTIC (52083-400-04) 120 ml2011-06-010000-00-00NoNoCurrent
52083-400-1652083040016474 mL in 1 BOTTLE, PLASTIC (52083-400-16) 474 ml2013-01-230000-00-00NoNoCurrent