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 8 of 59 · 1,176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepackff77a959-c77a-4911-8f7c-e2a3e24a63052026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepackf308fd07-f004-42de-963d-426b268bba932026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
SudoGestPSEUDOEPHEDRINE HYDROCHLORIDEMajor Pharmaceuticals78faa497-6743-b85b-e053-2a91aa0ae8222026-05-12WarningsExact identifier
unii: 6V9V2RYJ8N
Mucinex DS 12HR COLD, FEVER and SINUSNAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLC4e7e6674-c1ce-ea61-e063-6294a90afe042026-05-12WarningsExact identifier
unii: 6V9V2RYJ8N
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Companyfac55d76-457f-4258-9cc8-6edae539cada2026-05-08WarningsExact identifier
unii: V1Q0O9OJ9Z
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
Guaifenesin DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDERUGBY LABORATORIES, INC.997946e6-eff0-4c15-8694-020a19c2d3362026-05-06WarningsExact identifier
unii: 6V9V2RYJ8N
Acetaminophen and CodeineACETAMINOPHEN AND CODEINEBryant Ranch Prepack7d940b9c-7406-4182-9052-c6a5806337a02026-05-06Boxed warning, WarningsExact identifier
unii: GSL05Y1MN6
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEWinCo Foods, LLC27e911e1-6d22-4a50-8413-1809c8973cbd2026-05-06WarningsExact identifier
unii: V1Q0O9OJ9Z
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
Brompheniramine maleate, pseudoephedrine hydrochloride,BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE,Eywa Pharma Inc8a4b2d13-d1c9-416f-95fd-f7d7b7970bb52026-05-05Warnings, Adverse reactionsExact identifier
unii: 6V9V2RYJ8N
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP6980bfc5-15e4-48ec-9346-6f09f8f789002026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
Panadol Cold and Flu NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3417993d-8e3c-23d6-e063-6394a90a7d502026-04-29WarningsExact identifier
unii: V1Q0O9OJ9Z

Reported adverse events (FAERS/openFDA)#

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