Cough and Cold

Product NDC: 45014-151
11-digit product format: 450140151
Labeler code: 45014
Product ID: 45014-151_3c3797ea-03dd-41d3-8f2d-bcd80ee1c040
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine Maleate and Dextromethorphan Hydrobromide
Dosage form: LIQUID
Route: ORAL
Labeler: Accudial Pharmaceutical, Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2009-11-25
Marketing end: 0000-00-00
Substance: CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 1 mg/5mL; mg/5mL
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	45014-151		I	Inactivated by FDA		2026-10-15
excluded package	package	45014-151	45014-151-04	I	Inactivated by FDA		2026-10-15

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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`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	45014-151-04	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45014-151-04	2019-10-21	C162847	48780-1	956f9ecf-dca1-621f-e053-dbdaa90a74ad	Children's ACCUDIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45014-151-04	Cough and Cold	118 mL in 1 BOTTLE	LIQUID	118		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Chlorpheniramine Maleate	ACTIVE INGREDIENT	V1Q0O9OJ9Z	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
Chlorpheniramine	ACTIVE MOIETY	3U6IO1965U	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
Fruit	INACTIVE INGREDIENT	C2AIY4ERZC	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
Sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45014-151	COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]	1	Legacy NDC, 1 package rows	20091125_03401433-923e-4577-ba58-9087515c8053.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111440	chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral Solution	PSN	03401433-923e-4577-ba58-9087515c8053	1
1111440	chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution	SCD	03401433-923e-4577-ba58-9087515c8053	1
1111440	chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral Solution	SY	03401433-923e-4577-ba58-9087515c8053	1
1111440	chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution	SY	03401433-923e-4577-ba58-9087515c8053	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
45014-151-04	45014015104	118 mL in 1 BOTTLE	118 ml	Historical