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 14 of 59 · 1,176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: 1Q73Q2JULR
unii: XF417D3PSL
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
mucus relief dGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEH E B80acd350-7c96-4620-bd7c-848c85f157ed2026-01-27WarningsExact identifier
unii: 6V9V2RYJ8N
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutions9ca1321e-380a-48d7-8a58-c6501858c1c02026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutionsdff53120-a609-4720-bd69-2391798c7dee2026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutions297dc9ff-e34f-434b-b1a4-4c995a5bac8b2026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEST. MARY'S MEDICAL PARK PHARMACY48eb36ee-e9dc-a719-e063-6394a90aa85e2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRAmerisource Bergen0b58990f-2246-408e-9365-51f56bb6766c2026-01-20WarningsExact identifier
unii: V1Q0O9OJ9Z
Allergy and Sinus ReliefCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEKroger Company28d3aee3-52fb-4e87-a6f2-4634f1770a702026-01-19WarningsExact identifier
unii: 6V9V2RYJ8N
Nasal DecongestantPSEUDOEPHEDRINE HCLH E B22d241c5-a3fd-4619-8147-91d7a4c8cf982026-01-19WarningsExact identifier
unii: 6V9V2RYJ8N
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLBetter Living Brands, LLC9fe63ca6-3863-4175-9aec-ecd6ebbdb2492026-01-19WarningsExact identifier
unii: 6V9V2RYJ8N
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
unii: PDC6A3C0OX
Relief-PEACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINEHART Health9475fb51-931b-4a89-be6b-62e715d0883e2026-01-15WarningsExact identifier
unii: V1Q0O9OJ9Z
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLL.N.K. International, Inc.99147338-f459-4423-ae54-f96fffc1728d2026-01-15WarningsExact identifier
unii: V1Q0O9OJ9Z
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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