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 34 of 107 · 2,127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HCI	CVS Pharmacy, Inc.	f70f9fc4-4022-336e-e053-6394a90a4d07	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Discount Drug Mart Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Discount Drug Mart	f7fd53be-e501-d97f-e053-6394a90ad409	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Family Wellness Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Family Dollar Services, Inc.	facd53c4-9cfc-6589-e053-6394a90a180d	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Exchange Select Artificial Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Army and Air Force Exchange Service	9e478343-8ae7-823e-e053-2995a90a84ed	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Medics Choice Eye Drops Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	K.C. Pharmaceuticals, Inc.	f7131707-47af-d70a-e053-6394a90a418f	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
DG Health Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400	Dolgencorp LLC	9cb20c3b-bf6d-8c7c-e053-2995a90aa485	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
DG Maximum Strength Redness Relief	GLYCERIN, NAPHAZOLINE HCL	Dolgencorp, Inc	9cb261ed-b708-1189-e053-2a95a90a547d	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Winco Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	WinCo Foods, LLC	ff3651d4-42ce-4db1-a318-15f7592baf86	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Core Values Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Liberty Procurement Co. Inc.	f8285f68-c40c-19a8-e053-6394a90aacad	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Harris Teeter Eye Drops Artificial Tears	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Harris Teeter, LLC.	f82957d9-c4ad-a914-e053-6294a90aac50	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Harris Teeter Eye Drops Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Harris Teeter, LLC	f710d107-0403-21c5-e053-6394a90a0372	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Foster and Thrive Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Strategic Sourcing Services LLC	0042e9a0-9693-d7e0-e063-6294a90ae6c6	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
CareOne Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCI	Retail Business Services, LLC	9ab96aed-21d3-11b6-e053-2995a90a7225	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Equate Redness and Dry Eye Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Wal-Mart Stores, Inc.	ae228018-9238-2cbd-e053-2995a90a8d99	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Eye Love Heyedrate Long Lasting Hydration	GLYCERIN, POVIDONE	Physician Recommended Neutraceuticals, L.P.	f321dea1-3251-eaa8-e053-2995a90aaf95	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Quality Choice Eye Wash	WATER	Chain Drug Marketing Assoc., Inc.	1fb8a109-351b-7039-e063-6394a90a7311	2025-12-30	Warnings	Exact identifier unii: 059QF0KO0R
Rite Aid Eye Wash	PURIFIED WATER	Rite Aid	28a18e04-d735-a511-e063-6394a90af6bb	2025-12-30	Warnings	Exact identifier unii: 059QF0KO0R
Equate Optimal Hydration Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	Walmart, Inc.	151b9723-5d5e-ac2b-e063-6294a90af073	2025-12-30	Warnings	Exact identifier unii: PDC6A3C0OX
Mucus Relief DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Chain Drug Marketing Association, Inc.	d02f32c1-716e-4753-abba-ff97c4dc9e22	2025-12-30	Warnings	Exact identifier unii: 495W7451VQ
Tusnel EX	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	77c16288-68c4-476c-995f-86f505663270	2025-12-29	Warnings	Exact identifier unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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