NDC 43378-116 - Zodryl DAC 80

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: 43378-116
Package NDCs from labels: 43378-116-08
Manufacturer: CodaDose Inc. | Gorbec Pharmaceutical Services Inc | Gorbec Pharmaceutical Services Inc.
Effective date: 2009-09-22
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ZODRYL DAC 80 – chlorpheniramine maleate, codeine phosphate, and pseudoephedrine hydrochloride suspension	CodaDose Inc. \| Gorbec Pharmaceutical Services Inc \| Gorbec Pharmaceutical Services Inc.	2009-09-22	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43378-116-08	2019-10-21	C162847	48780-1	956f9ecf-db99-621f-e053-dbdaa90a74ad	ZODRYL DAC 80 – chlorpheniramine maleate, codeine phosphate, and pseudoephedrine hydrochloride suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43378-116-08	Zodryl DAC 80	236 mL in 1 BOTTLE, PLASTIC	SUSPENSION	236		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43378-116	ZODRYL DAC 80 (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) SUSPENSION [CODADOSE INC.]	1	1 package rows	20180616_a4553e9f-1170-43d3-bb4b-1d55259d9be9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43378-116-08	ML - Milliliter	43378-116	9b53fa05-8d34-40be-8529-fb610998df21	1	2013-02-13

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 58 · 1,159 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin and Pseudoephedrine Hydrochloride	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	c857bcd9-6696-40d5-93c0-65097598cd4b	2022-04-08	Warnings	Exact identifier unii: 6V9V2RYJ8N
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Proficient Rx LP	1b79a7d8-a8f4-4525-8b94-3e317fc5a717	2022-04-01	Warnings, Adverse reactions	Exact identifier unii: 6V9V2RYJ8N
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Proficient Rx LP	75b50751-5237-4e3e-b7ee-1605c0602f3b	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: GSL05Y1MN6
Miracle FootCream Lavender	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db520c80-2a2a-5eb1-e053-2995a90a5bb4	2022-03-28	Warnings	Exact identifier unii: PDC6A3C0OX
Miracle FootCream Lemon	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db525c63-29fd-2033-e053-2995a90a56b9	2022-03-28	Warnings	Exact identifier unii: PDC6A3C0OX
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b3c229a4-c772-70fb-e053-2a95a90a72db	2022-03-11	Warnings	Exact identifier unii: V1Q0O9OJ9Z
ACD-A	ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A	Fenwal, Inc.	22805f0d-ba58-41ea-b245-19980abcda22	2022-02-11		Exact identifier unii: 1Q73Q2JULR unii: XF417D3PSL
Guaifenesin and Pseudoephedrine Hydrochloride	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	d139fd8d-66fd-4484-8e78-ed90c505d999	2022-02-08	Warnings	Exact identifier unii: 6V9V2RYJ8N
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Ibuprofen and Pseudoephedrine HCl	IBUPROFEN AND PSEUDOEPHEDRINE HCL	Aurohealth LLC	6adf9292-b4af-4cb4-99f3-dda03734570a	2022-01-21	Warnings	Exact identifier unii: 6V9V2RYJ8N
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	d763511e-f1a7-4014-94b9-f7ad8f023ff4	2021-12-02		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	cf9f43a0-c750-4cf0-ac49-176ab2105aab	2021-12-02		Exact identifier unii: XF417D3PSL
Allergy Relief	CHLORPHENIRAMINE MALEATE	Good Sense	f88e2654-8e97-4cf6-9c36-01aeb51a9102	2021-11-30	Warnings	Exact identifier unii: V1Q0O9OJ9Z
Cold Medicine	COLD MEDICINE	Allegiant Health	443fbc44-2c33-4316-ad31-dcc5a5aa8f52	2021-11-23	Warnings	Exact identifier unii: V1Q0O9OJ9Z
NOCOLD-F	ACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Lydia Co., Ltd.	d0b20c56-de2a-1489-e053-2995a90a6a06	2021-11-13	Warnings	Exact identifier unii: V1Q0O9OJ9Z
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE	LGM PHARMA SOLUTIONS, LLC	180d20a5-78a8-4faa-98ad-3196cdd5663a	2021-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: GSL05Y1MN6

Reported adverse events (FAERS/openFDA)#

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