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 9 of 108 · 2,158 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eyesaline Emergency Eyewash	PURIFIED WATER	Protective Industrial Products, Inc.	55a261c2-725d-6765-e063-6294a90a3260	2026-07-02	Warnings	Exact identifier unii: 059QF0KO0R
equate mucus-er	GUAIFENESIN	WALMART INC.	a2cc6dec-388a-46bd-9cbc-1ffb6fd1aea3	2026-07-02	Warnings	Exact identifier unii: 495W7451VQ
COUGH AND CHEST CONGESTION	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Meijer, Inc.	9d355bf8-6398-4f3a-902a-c41cf5840c15	2026-07-02	Warnings	Exact identifier unii: 495W7451VQ
Remodulin	TREPROSTINIL	United Therapeutics Corporation	6c80bb38-e8db-4138-9f0d-dbbf9c673185	2026-07-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Green Guard Instydose Mucus Relief	GUAIFENESIN	Unifirst First Aid Corporation	5b21bd13-d649-6570-e063-6394a90a51e9	2026-07-01	Warnings	Exact identifier unii: 495W7451VQ
Medique Guaicon Insydose	GUAIFENESIN	Unifirst First Aid Corporation	5b230d04-3cf2-51e0-e063-6294a90a2498	2026-07-01	Warnings	Exact identifier unii: 495W7451VQ
TUSSIN CF SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amazon.com Services LLC	01d6c897-619d-4a6d-8950-4d6d32346b9b	2026-07-01	Warnings	Exact identifier unii: 495W7451VQ
Mucinex	GUAIFENESIN	Bryant Ranch Prepack	a898b584-e17e-45c4-8a28-9f686b95dca0	2026-06-29	Warnings	Exact identifier unii: 495W7451VQ
Sinus Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	259b6f12-50c0-4e7a-9a44-bdf7e9a20a56	2026-06-29	Warnings	Exact identifier unii: 495W7451VQ
Mucinex	GUAIFENESIN	Bryant Ranch Prepack	a8c67e0a-1f2c-4e96-91fe-0d90546d8b1b	2026-06-29	Warnings	Exact identifier unii: 495W7451VQ
Glycerin	GLYCERIN	Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd	552d9018-cc7d-7e1a-e063-6294a90a3322	2026-06-26	Warnings	Exact identifier unii: PDC6A3C0OX
Glycerin	GLYCERIN	Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd	552e16b9-f46a-7838-e063-6394a90ab8aa	2026-06-26	Warnings	Exact identifier unii: PDC6A3C0OX
MUCUS RELIEF DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	db57f6b3-30ca-4a65-9043-f61be24d9b50	2026-06-25	Warnings	Exact identifier unii: 495W7451VQ
Guaifenesin	GUAIFENESIN	YYBA CORP	4cb11551-31e3-5c01-e063-6394a90ab0d4	2026-06-25	Warnings	Exact identifier unii: 495W7451VQ
Chemstat	GLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,	Energique, Inc.	2e361b50-9268-4053-b13c-93af64549848	2026-06-25	Warnings	Exact identifier unii: PDC6A3C0OX
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea	2026-06-24	Warnings	Exact identifier unii: 495W7451VQ
Leukotrap WB System	CPDA-1 BLOOD BAG COLLECTION SYSTEM	GVS TM INC	54fd8a72-0527-df0c-e063-6294a90abe75	2026-06-24		Exact identifier unii: 1Q73Q2JULR
Leukotrap WB System	CPDA-1 BLOOD BAG COLLECTION SYSTEM	GVS TM INC	54fddca1-b40c-7af0-e063-6294a90a410e	2026-06-24		Exact identifier unii: 1Q73Q2JULR
Leukotrap WB System	CPDA-1 BLOOD BAG COLLECTION SYSTEM	GVS TM INC	54fdf83e-f641-1f69-e063-6394a90ab750	2026-06-24		Exact identifier unii: 1Q73Q2JULR
Fendall 2000 Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	37dead3e-60cb-88ae-e063-6294a90a8f70	2026-06-24	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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