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 64 of 107 · 2,121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydropure Lubricating Eye DropsGLYCERINOTE North America17f5b6e5-dc14-45c7-e063-6294a90af43d2025-02-14WarningsExact identifier
unii: PDC6A3C0OX
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINKROGER COMPANY9bb7aaf0-6698-9a5c-e053-2a95a90a097c2025-02-14WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Mucus ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association Inc.6c4e867b-24b9-4525-9fab-10f1e7910b132025-02-13WarningsExact identifier
unii: 495W7451VQ
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc821c3880-303d-470a-af6a-e13be7ab313f2025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
Cetirizine hydrochloride and Pseudoephedrine hydrochlorideCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd3260111b-35da-4f95-8081-51eae4b1ef452025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and ColdNAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC638a9664-4129-46fd-9ba1-d660a7366c9f2025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
topcare all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDETopco Associates LLC103df878-1455-414f-94cb-5b32a2d3e4b82025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
equate allergy relief d nasal decongestantCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEWALMART INC.7b7b8cce-ede6-47c6-91c8-88fd94cb292d2025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus ReliefGUAIFENESINP & L Development, LLCa2d14780-4a69-496e-86fe-7f2443cb0f202025-02-12WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINTopco Associates, LLC17d0dbc7-c8c2-7917-e063-6394a90a42af2025-02-12WarningsExact identifier
unii: 495W7451VQ
all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEKroger Company2f1df816-311b-444a-8040-21227016614b2025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacyfe26cba3-5b84-462c-ac2b-e9e09612ad1d2025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
Rugby Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERugby Laboratories5c6ac9a2-4f0a-4297-9b83-988d54598f752025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
signature care allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDESafeway8f2bcfe7-aac3-4a57-8ebb-c6f8a5829c802025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEH E Bb3ca8aae-04f2-4c00-9fb5-ce3ed7e6f1bb2025-02-11WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRPUBLIX SUPER MARKETS, INC74fa022a-bad9-4d0f-8dda-5624fae3867b2025-02-10WarningsExact identifier
unii: 495W7451VQ
MUCOSA DMGUAIFENESIN DEXTROMETHORPHANTIME CAP LABORATORIES, INC.62c1f4aa-6571-414c-9a58-31e107b7db972025-02-08WarningsExact identifier
unii: 495W7451VQ
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Childrens Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.2d95d5a4-34dc-e195-e063-6394a90a39da2025-02-07WarningsExact identifier
unii: 495W7451VQ
Tyson 2.0 Mike Red Eye Drops For Dry High EyesGLYCERIN, NAPHAZOLINE HCLJbrands Pharma L.L.C.288e9c85-0562-89bf-e063-6394a90a110d2025-02-07WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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