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 13 of 59 · 1,176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss DGILTUSS DGil Pharmaceutical Corp298f5457-a7df-474d-9854-68918ee3d3302026-02-12WarningsExact identifier
unii: V1Q0O9OJ9Z
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
FOSTER AND THRIVE ALLERGY AND CONGESTION DFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC945fcda4-0dd8-43cf-a5dd-ecea7995330a2026-02-11WarningsExact identifier
unii: 6V9V2RYJ8N
equate sinus 12 hourPSEUDOEPHEDRINE HYDROCHLORIDEWal-Mart Stores Incde65b99e-85e9-46c1-88b2-727c7ed8882a2026-02-11WarningsExact identifier
unii: 6V9V2RYJ8N
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
Ascomp with CodeineBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEBreckenridge Pharmaceutical, Inc.243a6aea-0f48-42a9-a85e-ff247ab943362026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
mucus relief dGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Company440c0cf6-d63d-4523-b137-26f70adb977a2026-02-07WarningsExact identifier
unii: 6V9V2RYJ8N
foster and thrive mucus relief dGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC235a465c-3a5e-4775-92e9-e57fd8d9c9b42026-02-07WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESportpharm LLC3b5c81b7-7464-129f-e063-6294a90a48c02026-02-06WarningsExact identifier
unii: 6V9V2RYJ8N
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLSportpharm LLC909dacfa-50d3-4bcf-b2df-5405427cfaad2026-02-06WarningsExact identifier
unii: 6V9V2RYJ8N
Cold and Allergy DPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLWalgreen Company832ac849-7f4a-489a-a704-9d4388a75a712026-02-03WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN CO.1425a847-bf34-1795-e063-6294a90a85b62026-02-03WarningsExact identifier
unii: 6V9V2RYJ8N
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions0a2672f0-4e6f-48c9-8571-2d09f06253d72026-01-29WarningsExact identifier
unii: 6V9V2RYJ8N
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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