Zodryl AC 50

Product NDC: 43378-104
11-digit product format: 433780104
Labeler code: 43378
Product ID: 43378-104_332c8ac7-01ed-4ec5-abb9-bdb98eefd043
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine Maleate and Codeine Phosphate
Dosage form: SUSPENSION
Route: ORAL
Labeler: CodaDose, Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2009-08-24
Marketing end: 0000-00-00
Substance: CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE
Active strength: 2 mg/5mL; mg/5mL
DEA schedule: CV
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43378-104		I	Inactivated by FDA		2026-08-11
excluded package	package	43378-104	43378-104-08	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43378-104-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43378-104-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43378-104-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43378-104-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43378-104-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43378-104-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43378-104-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43378-104-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43378-104-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43378-104-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43378-104-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43378-104-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43378-104-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43378-104-08	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43378-104-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43378-104-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43378-104-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43378-104-08	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43378-104-08	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43378-104-08	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43378-104-08	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	43378-104-08	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43378-104-08	2019-10-21	C162847	48780-1	956f9ecf-d0d1-621f-e053-dbdaa90a74ad	ZODRYL AC 50 – chlorpheniramine maleate and codeine phosphate suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43378-104-08	Zodryl AC 50	236 mL in 1 BOTTLE, PLASTIC	SUSPENSION	236		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43378-104-08	ML - Milliliter	43378-104	4d76b622-2f9a-464c-96c2-037120f3c7b4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
CODEINE	ACTIVE MOIETY	Q830PW7520	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
TANNIC ACID	INACTIVE INGREDIENT	28F9E0DJY6	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43378-104	ZODRYL AC 50 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]	1	Legacy NDC, 1 package rows	20090904_2d0bc8b8-bda7-46d3-9339-a3f69d8be841.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995123	codeine phosphate 1 MG / chlorpheniramine maleate 0.4 MG in 1 mL Oral Suspension	PSN	2d0bc8b8-bda7-46d3-9339-a3f69d8be841	1
995125	Zodryl AC 50, 1 MG / 0.4 MG in 1 mL Oral Suspension	PSN	2d0bc8b8-bda7-46d3-9339-a3f69d8be841	1
995125	chlorpheniramine maleate 0.4 MG/ML / codeine phosphate 1 MG/ML Oral Suspension [Zodryl AC]	SBD	2d0bc8b8-bda7-46d3-9339-a3f69d8be841	1
995123	chlorpheniramine maleate 0.4 MG/ML / codeine phosphate 1 MG/ML Oral Suspension	SCD	2d0bc8b8-bda7-46d3-9339-a3f69d8be841	1
995123	chlorpheniramine maleate 0.4 MG / codeine phosphate 1 MG per 1 ML Oral Suspension	SY	2d0bc8b8-bda7-46d3-9339-a3f69d8be841	1
995125	Zodryl AC 50 (chlorpheniramine maleate 0.4 MG / codeine phosphate 1 MG) per ML Oral Suspension	SY	2d0bc8b8-bda7-46d3-9339-a3f69d8be841	1
995125	Zodryl AC 50 (chlorpheniramine maleate 2 MG / codeine phosphate 5 MG) per 5 ML Oral Suspension	SY	2d0bc8b8-bda7-46d3-9339-a3f69d8be841	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
43378-104-08	43378010408	236 mL in 1 BOTTLE, PLASTIC	236 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZODRYL AC 50 – chlorpheniramine maleate and codeine phosphate suspension	CodaDose, Inc. \| Gorbec Pharmaceutical Services Inc.	2009-08-24	HUMAN OTC DRUG LABEL	1