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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43378-122-04	2019-10-21	C162847	48780-1	956f9ecf-d845-621f-e053-dbdaa90a74ad	ZODRYL DEC 35 - codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43378-122-04	Zodryl DEC 35	118 mL in 1 BOTTLE, PLASTIC	SUSPENSION	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43378-122	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	2	1 package rows	20180616_49a51f00-cc86-44ad-b806-d4be9ae71391.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43378-122-04	ML - Milliliter	43378-122	b282f40b-1804-4344-a1cd-cb4962b51c72	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
CODEINE	ACTIVE MOIETY	Q830PW7520	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
TANNIC ACID	INACTIVE INGREDIENT	28F9E0DJY6	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZODRYL DEC 35 (CODEINE PHOSPHATE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ZODRYL 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 35 of 107 · 2,127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tusnel DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Llorens Pharmaceutical International Division, Inc.	fe457e6d-422d-496c-bcb9-33594f3c42ff	2025-12-29	Warnings	Exact identifier unii: 495W7451VQ
Tusnel Diabetic	DEXTROMETHORPHAN, GUAIFENESIN	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	66b3c094-809e-4d2c-bc15-46563de685cb	2025-12-29	Warnings	Exact identifier unii: 495W7451VQ
OCUFRESH	WATER	Optics Laboratory Inc.	b8e477a9-66b9-496b-92fb-3d4bbd7b36b5	2025-12-29	Warnings	Exact identifier unii: 059QF0KO0R
Kollourion Eyesalve Eyewash	PURIFIED WATER 98.3%	Miracle Eye Pharmaceuticals	b56d2ab9-169b-b490-e053-2a95a90a80b3	2025-12-28	Warnings	Exact identifier unii: 059QF0KO0R
Sorbutuss NR	SORBUTUSS	Dextrum Laboratories Inc.	304f1d5a-218c-51ae-e054-00144ff88e88	2025-12-26	Warnings	Exact identifier unii: 495W7451VQ
TUSSIN CF	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	AptaPharma Inc.	c005c6cf-7891-463e-b65d-1129ad4bf6ec	2025-12-26	Warnings	Exact identifier unii: 495W7451VQ
CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	AptaPharma Inc.	9ae6fe74-80cd-482a-b3b9-3acafd6708ec	2025-12-26	Warnings	Exact identifier unii: 495W7451VQ
Tussin Expectorant	GUAIFENESIN	AptaPharma, Inc.	ca8fa216-09c1-42b2-a95b-fa3d0f13363c	2025-12-26	Warnings	Exact identifier unii: 495W7451VQ
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	3b7e0ee7-4dda-4bbe-842c-6cbbc208acd5	2025-12-26	Warnings	Exact identifier unii: 495W7451VQ
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f	2025-12-26	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief DM	DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG	Pioneer Life Sciences, LLC	3ce0f096-906e-47eb-8061-0ac1e9d8ea55	2025-12-26	Warnings	Exact identifier unii: 495W7451VQ
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	1194c338-e115-4105-93d8-9ab833c43193	2025-12-26	Warnings	Exact identifier unii: 495W7451VQ
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	9c9e558d-d991-4a2e-aa13-37c0b08071e6	2025-12-26	Warnings	Exact identifier unii: 495W7451VQ
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	1695e7ea-2f83-4d3a-980e-c91be6c1f2a5	2025-12-25	Warnings	Exact identifier unii: 495W7451VQ
GUAIFENESIN	GUAIFENESIN	Pharbest Pharmaceuticals, Inc.	0bf70fb4-d3c8-476d-b864-4eadc697a7d8	2025-12-24	Warnings	Exact identifier unii: 495W7451VQ
CETAFEN COUGH and COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,	HART Health	44da0d8c-4a12-4122-99da-781e2809e1a8	2025-12-24	Warnings	Exact identifier unii: 495W7451VQ
PHARBINEX-DM	GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG	Pharbest Pharmaceuticals, Inc.	8d71db43-da87-45ee-aa4a-7e870bc5016d	2025-12-24	Warnings	Exact identifier unii: 495W7451VQ
Tussin	GUAIFENESIN	Discount Drug Mart	14de3d6d-4eb0-42cf-8941-cb42b3dd5c71	2025-12-23	Warnings	Exact identifier unii: 495W7451VQ
SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	920bde5f-4079-45de-aa59-24b00e50cb56	2025-12-23	Warnings	Exact identifier unii: 495W7451VQ
Guaiasorb DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	NuCare Pharmaceuticals, Inc.	46a480c7-7092-b809-e063-6294a90a60cd	2025-12-23	Warnings	Exact identifier unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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