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 58 of 59 · 1,176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc9a6ece8b-7036-4cad-aeb3-993ef4bf614f2019-03-14WarningsExact identifier
unii: 6V9V2RYJ8N
Cold Multi-Symptom Night-timeACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCIAllegiant Health3f020cf2-6011-4216-9b39-0b3dc5f0749c2018-12-26WarningsExact identifier
unii: V1Q0O9OJ9Z
AllergyCHLORPHENIRAMINE MALEATEAllegiant Health4305ad50-d2a5-4d3e-9d92-cbf26e856a162018-12-26WarningsExact identifier
unii: V1Q0O9OJ9Z
Chlorphen-12CHLORPHENIRAMINE MALEATEKVK-Tech, Inc.84409269-fe9b-469e-9a66-27b1475231a32018-12-19WarningsExact identifier
unii: V1Q0O9OJ9Z
Allergy TimeCHLORPHENIRAMINE MALEATETime Cap Labs Inc588c424a-8dd6-417e-8f76-2ce0cc2b0c122018-12-17WarningsExact identifier
unii: V1Q0O9OJ9Z
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEDiscount Drug Mart7ced0e53-3493-c6a7-e053-2991aa0a80cd2018-12-13WarningsExact identifier
unii: V1Q0O9OJ9Z
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIDr.Reddy's Laboratories Limited25cca459-fdd6-3847-2207-dd4f019781b52018-12-05WarningsExact identifier
unii: 6V9V2RYJ8N
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECHAIN DRUG CONSORTIUM,LLC0f5de86d-1c87-4664-83f6-4c17f78f7d352018-11-30WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN COMPANY310d14be-e7ea-44b8-8b04-cffa39440d502018-10-27WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIThe Kroger Co.8cf0b878-ec13-fd44-d56f-f44af7c249ed2018-10-01WarningsExact identifier
unii: 6V9V2RYJ8N
Best Choice Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEValu Merchandiser Company76df52ed-e905-4075-e053-2991aa0a26182018-09-27WarningsExact identifier
unii: V1Q0O9OJ9Z
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEH E B5167ab78-f898-47ec-8baf-843269469d102018-07-18WarningsExact identifier
unii: 6V9V2RYJ8N
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 1Q73Q2JULR
unii: A2I8C7HI9T
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy02476e5a-0463-4223-8dc5-8bbe787d38dc2018-05-31WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIThe Kroger Co.cb9e98a9-74e6-7a3e-9c5e-3bc35c4bbca62017-12-07WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIHEB0de7fc37-7f46-4e98-d5ac-d31a3c313a622017-12-07WarningsExact identifier
unii: 6V9V2RYJ8N
Chlorpheniramine maleate 4mgCHLORPHENIRAMINE MALEATE 4MGAthlete's Needs, Inc.4d974959-25fc-4707-9b72-9afbf47b76f12017-11-14WarningsExact identifier
unii: V1Q0O9OJ9Z
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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