FDA.reportPublic FDA data

NDC 43378-102 - Zodryl AC 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
43378-102
Package NDCs from labels
43378-102-04
Manufacturer
CodaDose, Inc. | Gorbec Pharmaceutical Services Inc.
Effective date
2009-08-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZODRYL AC 35 – chlorpheniramine maleate and codeine phosphate suspensionCodaDose, Inc. | Gorbec Pharmaceutical Services Inc.2009-08-24HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43378-102-042019-10-21C16284748780-1956f9ecf-dec6-621f-e053-dbdaa90a74adZODRYL AC 35 – chlorpheniramine maleate and codeine phosphate suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43378-102-04Zodryl AC 35118 mL in 1 BOTTLE, PLASTICSUSPENSION1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43378-102ZODRYL AC 35 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]41 package rows20180616_07af42d8-4b0c-4cd1-b299-42dc12980b94.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43378-102-04ML - Milliliter43378-102ee3bcf16-dd09-4a29-8610-0a8e770c105212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
CODEINEACTIVE MOIETYQ830PW7520ZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
TANNIC ACIDINACTIVE INGREDIENT28F9E0DJY6ZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1

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 46 · 920 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALKA SELTZER COLD Cold and Flu Severe Fast ChewablesCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5025a333-6378-bf59-e063-6394a90af4f02026-04-23WarningsExact identifier
unii: V1Q0O9OJ9Z
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
unii: PDC6A3C0OX
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRValu Merchandisers Company83db90da-9155-4f6a-8209-44c87d14b6962026-04-21WarningsExact identifier
unii: V1Q0O9OJ9Z
Multi-Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companybf3158af-89ab-4b7c-9f39-0f316fbe90562026-04-17WarningsExact identifier
unii: V1Q0O9OJ9Z
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: PDC6A3C0OX
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
unii: PDC6A3C0OX
Alka Seltzer Cold Cold and Congestion Severe Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.4f0c1b8e-3fb1-ccf2-e063-6394a90acd152026-04-09WarningsExact identifier
unii: V1Q0O9OJ9Z
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
unii: PDC6A3C0OX
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Cold and AllergyCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDOLGENCORP, LLCb55452e1-25d0-4db5-9621-83f21ec6c2982026-04-06WarningsExact identifier
unii: V1Q0O9OJ9Z
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Allergy ReliefCHLORPHENIRAMINE MALEATEStrategic Sourcing Services LLCc9fa8d93-d9d6-4206-a13d-32b9e7555e7f2026-04-02WarningsExact identifier
unii: V1Q0O9OJ9Z
SudoGestCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLMajor Pharmaceuticals7cd8f7f3-c262-4f7c-bcaf-068be2c952f92026-04-01WarningsExact identifier
unii: V1Q0O9OJ9Z
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINMethod Pharmaceuticals, LLCfe126254-6ee6-48c3-965c-96e4276a53142026-04-01WarningsExact identifier
unii: GSL05Y1MN6
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINA-S Medication Solutionsc26da6e0-ab1c-46c2-acf5-0074958c03cd2026-03-31WarningsExact identifier
unii: GSL05Y1MN6
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCardinal Health 110, LLC. DBA Leaderba174fcc-da1e-420c-bf9c-179ad65c28482026-03-31WarningsExact identifier
unii: V1Q0O9OJ9Z

Reported adverse events (FAERS/openFDA)#

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