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 55 of 107 · 2,127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Refresh RELIEVA PF	CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN	Allergan, Inc.	d5d3df4a-a311-4f2d-9a24-edfec1a6c9f9	2025-08-22	Warnings	Exact identifier unii: PDC6A3C0OX
Refresh Optive	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	Allergan, Inc.	37e99aa8-02d6-4efb-a862-90bc7fcd5ca5	2025-08-22	Warnings	Exact identifier unii: PDC6A3C0OX
MUCUS RELIEF - DM MAXIMUM STRENGTH	GUAIFENESIN, DEXTROMETHORPHAN HBR	YYBA CORP	325b5e55-ba58-312c-e063-6394a90aee55	2025-08-21	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief	GUAIFENESIN	Rite Aid Corporation	73fb2194-a582-4d3c-bc82-c5f110efcd81	2025-08-20	Warnings	Exact identifier unii: 495W7451VQ
Severe Cold Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	258d27a9-fea6-4076-8dfa-77c7e982d250	2025-08-20	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief DM Maximum Strength	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rite Aid Corporation	8467474f-6278-47d9-8228-451d08ddf983	2025-08-20	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rite Aid Corporation	035693ed-d720-430b-98f5-fe4b5dec5db6	2025-08-20	Warnings	Exact identifier unii: 495W7451VQ
Adult Cough and Chest Congestion Relief DM Non Drowsy	DEXTROMETHORPHAN HBR, GUAIFENESIN	Safeway, Inc.	5bd508a0-2f75-413e-a690-bed970131bef	2025-08-19	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief	GUAIFENESIN	BJWC (Berkley & Jensen / BJ's)	2f32e8f9-260c-fa36-e063-6294a90a953d	2025-08-19	Warnings	Exact identifier unii: 495W7451VQ
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Asclemed USA, Inc.	682ef287-647a-4d89-9bbf-75907ebd10f2	2025-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: GSL05Y1MN6
Upside Down Pain Relief	BENZOCAINE, GLYCERIN	Fridababy, LLC	31c2cd25-1fec-5ec5-e063-6394a90a24b4	2025-08-15	Warnings	Exact identifier unii: PDC6A3C0OX
Dr Simi Mucus Relief Expectorant	GUAIFENESIN	Farmacias De Similares TX LLC	3c6d0e75-a685-6020-e063-6294a90a5c1b	2025-08-15	Warnings	Exact identifier unii: 495W7451VQ
Maximum Strength Mucus Relief	GUAIFENESIN	SAM'S WEST INC	39282544-e1e8-8270-e063-6394a90a23fe	2025-08-13	Warnings	Exact identifier unii: 495W7451VQ
GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTH	DEXTROMETHORPHAN HBR AND GUAIFENESIN	AMERISOURCE BERGEN	2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e	2025-08-12	Warnings	Exact identifier unii: 495W7451VQ
Maximum Strength Mucus DM Extended Release	GUAIFENESIN AND DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc.	5ea560d1-6443-4271-842c-7801fc6a6043	2025-08-11	Warnings	Exact identifier unii: 495W7451VQ
Mucus DM Extended Release	GUAIFENESIN AND DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc.	2aa1889f-bb76-4e70-81b5-c25c4ebab113	2025-08-11	Warnings	Exact identifier unii: 495W7451VQ
Norms Hemorrhoid	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	Totally Normal Company	3bdf8c74-3db6-1805-e063-6394a90aaba0	2025-08-08	Warnings	Exact identifier unii: PDC6A3C0OX
Diabetic Tussin DM Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	MEDTECH PRODUCTS INC	a10a3b33-7503-4334-8ed7-2bb881df4327	2025-08-08	Warnings	Exact identifier unii: 495W7451VQ
Durma DynaGel	DURMA DYNAGEL	Dynarex Corporation	3bcbe314-98ca-78f1-e063-6394a90a13ad	2025-08-07	Warnings	Exact identifier unii: PDC6A3C0OX
Medics Choice Fresh and Soothe	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	Unimed	3bcd8394-f486-d306-e063-6294a90a4e9a	2025-08-07	Warnings	Exact identifier unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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