NDC 43378-122 - Zodryl DEC 35

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
43378-122
Package NDCs from labels
43378-122-04
Manufacturer
CodaDose, Inc. | Gorbec Pharmaceutical Services Inc.
Effective date
2009-09-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zodryl DEC 35 - CodaDose, Inc. | Gorbec Pharmaceutical Services Inc.CodaDose, Inc. | Gorbec Pharmaceutical Services Inc.2009-09-11HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43378-122-042019-10-21C16284748780-1956f9ecf-d845-621f-e053-dbdaa90a74adZODRYL DEC 35 - codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43378-122-04Zodryl DEC 35118 mL in 1 BOTTLE, PLASTICSUSPENSION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43378-122ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]21 package rows20180616_49a51f00-cc86-44ad-b806-d4be9ae71391.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43378-122-04ML - Milliliter43378-122b282f40b-1804-4344-a1cd-cb4962b51c7212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
CODEINEACTIVE MOIETYQ830PW7520ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
TANNIC ACIDINACTIVE INGREDIENT28F9E0DJY6ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]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 88 of 107 · 2,121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDERugby Laboratoriescc6df813-9175-4c0b-a8e4-afcaa3aa833f2024-05-06WarningsExact identifier
unii: 6V9V2RYJ8N
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
unii: PDC6A3C0OX
Robitussin Honey Maximum Strength Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCeaa10aed-5b1e-48bf-bc05-7a5638851daf2024-05-03WarningsExact identifier
unii: 495W7451VQ
Theraflu-D Flu Relief Max Strength plus Nasal DecongestantACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLCe35cb719-9e7d-4b2b-81a4-29e147dd74fa2024-05-03WarningsExact identifier
unii: 6V9V2RYJ8N
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLC09e20842-2b75-43b9-ae5f-3515b35e655b2024-05-03WarningsExact identifier
unii: 6V9V2RYJ8N
Tussin CF Non Drowsy Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLC8ee27600-4f8e-406a-8ea3-eade691448f62024-05-03WarningsExact identifier
unii: 495W7451VQ
SanaTos Children Cough and Congestion CherryDEXTROMETHORPHAN HBR AND GUAIFENESINPharmadel LLC60437d86-9e13-8d8a-e053-2991aa0a23172024-05-02WarningsExact identifier
unii: 495W7451VQ
QCH Adult Tussin 541GUAIFENESINChain Drug Marketing Association Inc.b487f4af-ad0c-4f18-9a6b-7fd386b3f46c2024-05-02WarningsExact identifier
unii: 495W7451VQ
Mucus Relief 600 mgGUAIFENESINGuardian Drug Companye7742a43-9066-4e28-a90d-f07c0e18f0452024-04-30WarningsExact identifier
unii: 495W7451VQ
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: XF417D3PSL
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM,Deseret Biologicals, Inc.c77d0682-a000-4783-a91c-d4e205c347742024-04-29WarningsExact identifier
unii: XF417D3PSL
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy45d3ad69-a80a-4f91-9c9b-8b19a30144a32024-04-26WarningsExact identifier
unii: 6V9V2RYJ8N
QCH Maximum Strength Mucus Relief DM 628DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.a2795bf5-34c6-4de6-b9e5-53a23d18e3572024-04-26WarningsExact identifier
unii: 495W7451VQ
Severe Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEP & L Development, LLC5872fed8-862b-44a2-a06e-51ebf86182712024-04-25WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefMUCUS RELIEFAllegiant Health3ed75cff-ee25-4105-b0a0-afbe5bc93b622024-04-24WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Maximum StrengthMUCUS RELIEFAllegiant Health3d6c30d7-cd02-44a2-b48e-cd65f2896bfd2024-04-23WarningsExact identifier
unii: 495W7451VQ
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLWALGREEN CO.4c3b99f0-83af-4df0-a681-f2fc8778f8bb2024-04-20WarningsExact identifier
unii: 6V9V2RYJ8N
unii: 495W7451VQ
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINFamily Dollar Services, Inc.07ad76cc-2a6c-4a88-a5e9-5e8f6d1319e32024-04-17WarningsExact identifier
unii: 495W7451VQ
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEBryant Ranch Prepackdf2c24ba-1c88-4ec3-b2a1-801358ec645c2024-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6

Reported adverse events (FAERS/openFDA)#

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