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 56 of 107 · 2,127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader 12 Hour Sinus Nasal Decongestant	PSEUDOEPHEDRINE HCL	Cardinal Health 110, LLC. dba Leader	a647e822-c4dd-46fd-bd55-bd9226990357	2025-08-07	Warnings	Exact identifier unii: 6V9V2RYJ8N
Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	b7434978-44a8-4c51-979d-0bc446461e43	2025-08-06	Warnings	Exact identifier unii: 495W7451VQ
mucus dm extended release	GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE	CVS Pharmacy	6c9540ae-aea1-4717-8dca-60850ebdb1b4	2025-08-04	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief ER	GUAIFENESIN	Rugby Laboratories	2e6901aa-16f6-9b73-e063-6294a90a4d72	2025-08-02	Warnings	Exact identifier unii: 495W7451VQ
Medics Choice Fresh and Soothe	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	KC Pharmaceuticals, Inc.	3bc03d54-6b31-5921-e063-6294a90af599	2025-08-01	Warnings	Exact identifier unii: PDC6A3C0OX
GUAIFENESIN	GUAIFENESIN	Sam's West Inc	3867a132-1a87-5e08-e063-6294a90a6dc8	2025-08-01	Warnings	Exact identifier unii: 495W7451VQ
tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS Pharmacy	087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca	2025-07-31	Warnings	Exact identifier unii: 495W7451VQ
Respiratory Relief	GUAIFENESIN	Schwabe North America, Inc	f683041a-4ff9-42a5-9047-a9a3140a8758	2025-07-29	Warnings	Exact identifier unii: 495W7451VQ
Childrens Robitussin Honey Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	b87f700e-3414-463c-80d4-c3dbca89a488	2025-07-29	Warnings	Exact identifier unii: 495W7451VQ
MUCUS RELIEF DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Better Living Brands LLC	dca1d482-062f-4915-b0a7-c00ab47aaff8	2025-07-25	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief DM MAXIMUM STRENGTH	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Better Living Brands LLC	4ee69f46-3dc6-4249-9b04-186fa0a13e84	2025-07-25	Warnings	Exact identifier unii: 495W7451VQ
Doctor Butler Hemorrhoid and Fissure Advanced Formula	GLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%	Beyond Health, PA	d2a769e2-afd0-aed2-e053-2995a90ad429	2025-07-23	Warnings	Exact identifier unii: PDC6A3C0OX
Tussin DM	TUSSIN DM	Allegiant Health	7a2f8d48-3123-4c37-b238-bd7cc4242bb7	2025-07-23	Warnings	Exact identifier unii: 495W7451VQ
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GADAL Laboratories, Inc	5fb2438b-8f2d-4af2-9981-42d278d26800	2025-07-23	Warnings	Exact identifier unii: 495W7451VQ
DR. SANA COUGH AND CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GADAL Laboratories, Inc	baca0580-4c30-4b94-89fa-a7cf06d4ff25	2025-07-22	Warnings	Exact identifier unii: 495W7451VQ
Defensol Adult Syrup	GUAIFENESIN, DEXTROMETHORPHAN HBR	Menper Distributors, Inc.	62acff69-8c40-4a0e-8d56-be2cc14e3d45	2025-07-22	Warnings	Exact identifier unii: 495W7451VQ
Cosedal Drops	DEXTROMETHORPHAN HBR, GUAIFENESIN	Menper Distributors, Inc.	1241d249-ea3b-4d2b-87ed-835d6a2d286a	2025-07-22	Warnings	Exact identifier unii: 495W7451VQ
Berro y Cebolla DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Menper Distributors, Inc.	20107bd9-6d84-4ab5-a0d9-966f1f11d919	2025-07-22	Warnings	Exact identifier unii: 495W7451VQ
Defensol-ito	DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE	Menper Distributors, Inc	a7c7a60d-d49f-4239-92f7-714eac7eb0c5	2025-07-22	Warnings	Exact identifier unii: 495W7451VQ
Bisolvine Children	GUAIFENESIN, DEXTROMETHORPHAN	MENPER DISTRIBUTORS INC.	896a5443-e3d2-4af7-9e27-f1c1899ce038	2025-07-22	Warnings	Exact identifier unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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