FDA.reportPublic FDA data

NDC 43378-112 - Zodryl DAC 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
43378-112
Package NDCs from labels
43378-112-04
Manufacturer
CodaDose Inc. | Gorbec Pharmaceutical Services Inc.
Effective date
2009-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zodryl DAC 35 - CodaDose Inc. | Gorbec Pharmaceutical Services Inc.CodaDose Inc. | Gorbec Pharmaceutical Services Inc.2009-09-22HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43378-112-042019-10-21C16284748780-1956f9ecf-dabe-621f-e053-dbdaa90a74adZODRYL DAC 35 – chlorpheniramine maleate, codeine phosphate, and pseudoephedrine hydrochloride suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43378-112-04Zodryl DAC 35118 mL in 1 BOTTLE, PLASTICSUSPENSION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43378-112ZODRYL DAC 35 (CHLORPHENIRAMINE MALEATE,CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE INC.]11 package rows20180616_4301180e-50b6-4e90-9ece-6e6c43bc5613.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43378-112-04ML - Milliliter43378-11258328f5a-922a-430f-9397-f07452442bfe12013-02-13

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 46 of 59 · 1,176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABREVA Rapid Pain ReliefGLYCERIN, LIDOCAINEHaleon US Holdings LLC65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d2024-06-20WarningsExact identifier
unii: PDC6A3C0OX
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINNuCare Pharmaceuticals,Inc.9e691264-d48a-6b48-e053-2995a90a93522024-06-20WarningsExact identifier
unii: GSL05Y1MN6
SUDOGESTPSEUDOEPHEDRINE HCLA-S Medication Solutions1811199f-bf88-475f-8f94-b372db4bead32024-06-20WarningsExact identifier
unii: 6V9V2RYJ8N
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.8f12016d-904f-00b4-e053-2a95a90ad02a2024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.80c9a58d-98ae-5497-e053-2991aa0a61fb2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
MegaBabe Butt Stuff HemorrhoidalCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEMEGABABE, LLC01c156ff-69f9-4d5e-a9ea-abbc52d4afff2024-06-12WarningsExact identifier
unii: PDC6A3C0OX
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.7d69403e-90d0-7a80-e053-2a91aa0a55522024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.6f2ce909-6356-1c2c-e053-2a91aa0a01352024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy, Inc.e9161bb2-190f-14b3-e053-2995a90a9b2f2024-06-01WarningsExact identifier
unii: 6V9V2RYJ8N
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
good neighbor pharmacy nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEAmerisource Bergend84a0c76-ad50-4616-9252-84ca25a19ca02024-05-30WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEwalgreens1ed05c85-7a1c-440d-a5d7-e229528cedcd2024-05-28WarningsExact identifier
unii: 6V9V2RYJ8N
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEStrides Pharma Science Limitedc459ed02-afd6-4533-82b6-bfb2c7ab0e722024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKROGER COMPANYb8b2c45d-3aba-d98a-e053-2a95a90a879b2024-05-18WarningsExact identifier
unii: 6V9V2RYJ8N
Chlorpheniramine Maleate 4 mgCHLORPHENIRAMINE MALEATEBryant Ranch Prepack54681242-c861-4415-b5c0-d3ab55b62be12024-05-17WarningsExact identifier
unii: V1Q0O9OJ9Z
Childrens Plus Multi Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWalgreensdd967cfb-96b4-4cdc-82e2-a4838001c9e32024-05-08WarningsExact identifier
unii: V1Q0O9OJ9Z
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECardinal Healthc3b40d04-7eef-4c80-a604-808d2be72ad72024-05-06WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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