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 59 of 107 · 2,127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
12 hour allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEMeijer Distribution Incb7019ea1-ca3d-4ddb-8cf4-e4ca7cb95e772025-06-19WarningsExact identifier
unii: 6V9V2RYJ8N
Cough OutGUAIFENESINEfficient Laboratories Inc.fe4c3921-8d30-4cd6-ba90-9211b362a38a2025-06-18WarningsExact identifier
unii: 495W7451VQ
Guaifenesin STRAWBERRY-BANANA FLAVORGUAIFENESINInnovida Pharmaeutique Corporation1006906e-d6d7-4f49-92bf-3cb2d2cdbb162025-06-18WarningsExact identifier
unii: 495W7451VQ
Mucinex Sinus Max Clear and CoolACETAMINOPHEN AND GUAIFENESINRB Health (US) LLC37de813a-54b7-672a-e063-6294a90a374e2025-06-18WarningsExact identifier
unii: 495W7451VQ
Good Neighbor Pharmacy Mucus ERGUAIFENESINAmerisource Bergen5810b584-bbfa-4dd2-b237-71520a214c092025-06-17WarningsExact identifier
unii: 495W7451VQ
mucus extended releaseGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED9fcf96a7-bef4-4cc8-bd9e-c245ccbea17d2025-06-17WarningsExact identifier
unii: 495W7451VQ
Rugby Mucus Relief ERGUAIFENESINRugby Laboratories1c579aea-c9c5-44d0-997b-f350f84ac6d02025-06-17WarningsExact identifier
unii: 495W7451VQ
ADVIL COLD AND SINUSIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLCfac22a47-f0de-4505-fd8a-768430cda0c12025-06-13WarningsExact identifier
unii: 6V9V2RYJ8N
ZYRTEC-D Allergy Plus CongestionCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC1e8eb279-3522-40e4-8062-06b5354f0d292025-06-12WarningsExact identifier
unii: 6V9V2RYJ8N
SAFETUSSIN Non Drowsy Cough plus chest congestionDEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES60311ca3-8544-417e-aa29-e9f65c6692ba2025-06-11WarningsExact identifier
unii: 495W7451VQ
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limited8877bb8d-479f-4968-8033-5c269d449a462025-06-10WarningsExact identifier
unii: 495W7451VQ
Mucinex Maximum StrengthGUAIFENESINA-S Medication Solutions7e09314c-3421-4053-a2ac-b67bf5610f832025-06-09WarningsExact identifier
unii: 495W7451VQ
DG health mucus er maxGUAIFENESINDolgencorp Inc4353d561-0e6d-4d36-b356-dd6506b5a3ee2025-06-06WarningsExact identifier
unii: 495W7451VQ
Geri-Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp7e2fb43c-a7f1-4c1d-a700-7c6510999c032025-06-05WarningsExact identifier
unii: 495W7451VQ
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepacka6e9b316-549d-4058-8c08-407e4ce5c2552025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEATLANTIC BIOLOGICALS CORP.f8fb13e3-bc09-4004-a911-a38b6bbb00582025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAdvanced Rx of Tennessee, LLC36988ba2-cefd-99f8-e063-6294a90aa41a2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAdvanced Rx of Tennessee, LLC3698e0ff-6a1c-e1ad-e063-6294a90a163a2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.7ab27392-9c6e-4ec3-85e7-06b43fcab3b12025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6

Reported adverse events (FAERS/openFDA)#

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