FDA.reportPublic FDA data

NDC 43378-122 - Zodryl DEC 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
43378-122
Package NDCs from labels
43378-122-04
Manufacturer
CodaDose, Inc. | Gorbec Pharmaceutical Services Inc.
Effective date
2009-09-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zodryl DEC 35 - CodaDose, Inc. | Gorbec Pharmaceutical Services Inc.CodaDose, Inc. | Gorbec Pharmaceutical Services Inc.2009-09-11HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43378-122-042019-10-21C16284748780-1956f9ecf-d845-621f-e053-dbdaa90a74adZODRYL DEC 35 - codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43378-122-04Zodryl DEC 35118 mL in 1 BOTTLE, PLASTICSUSPENSION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43378-122ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]21 package rows20180616_49a51f00-cc86-44ad-b806-d4be9ae71391.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43378-122-04ML - Milliliter43378-122b282f40b-1804-4344-a1cd-cb4962b51c7212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
CODEINEACTIVE MOIETYQ830PW7520ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
TANNIC ACIDINACTIVE INGREDIENT28F9E0DJY6ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) 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 2 of 108 · 2,158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense mucus erGUAIFENESINL. Perrigo Companydef40c3f-29de-4efc-b1d3-4cb89183aaec2026-09-03WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCITARGET Corporation1bf9a59e-cc37-4780-ba75-7138c546eb192026-09-02WarningsExact identifier
unii: 495W7451VQ
Kroger Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLKROGER COMPANY1ff037ea-1a3b-430a-be31-2e240cc3b6f32026-09-02WarningsExact identifier
unii: 495W7451VQ
KROGER Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINKROGER COMPANY79d24014-1af7-4d62-bcb8-5bea76a7d6ee2026-09-02WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
unii: 495W7451VQ
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
unii: 495W7451VQ
Leader Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leader7c54d128-9da7-49d7-bda4-9d4f7b8bc6522026-09-01WarningsExact identifier
unii: 495W7451VQ
MAX Tussin Cough and Chest Congestion DM Sugar FreeDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.5c4c8115-cec9-4f2c-9ea9-328535e97b072026-09-01WarningsExact identifier
unii: 495W7451VQ
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN CO.4daddd32-615f-aedf-e063-6394a90a5b092026-09-01WarningsExact identifier
unii: 6V9V2RYJ8N
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsExact identifier
unii: 495W7451VQ
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsExact identifier
unii: 495W7451VQ
MAX Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.e0ce4287-bfa1-4413-97c8-4fe2e39bda362026-08-31WarningsExact identifier
unii: 495W7451VQ
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDESelect Consumer Group3c9c8fb0-8a00-4b0f-e063-6394a90af6322026-08-30WarningsExact identifier
unii: 495W7451VQ
Tussin DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED432d4833-2eaf-4f7c-b6b4-41043a6b7e2a2026-08-28WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRWal-Mart Stores, Inc.ff7280e7-804b-423d-add8-54ec2c76fca22026-08-28WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Companyd8a693f7-03c1-4583-89a8-8d506a894b242026-08-28WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyvee Inc4e578c7a-88d4-e4cd-e063-6394a90aac442026-08-27WarningsExact identifier
unii: 495W7451VQ
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.40d4a71e-341e-48b3-b925-ba35b7910dff2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsExact identifier
unii: 495W7451VQ
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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