Chlorpheniramine maleate 4mg

Product NDC: 53185-277
11-digit product format: 531850277
Labeler code: 53185
Product ID: 53185-277_3bbe161c-4342-40b5-82b6-5270ef0e31d3
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine maleate 4mg
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Athlete's Needs, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-15
Substance: CHLORPHENIRAMINE MALEATE
Active strength: 4 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Chlorpheniramine maleate 4mg
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPHENIRAMINE MALEATE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1Q0O9OJ9Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1363309	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4d974959-25fc-4707-9b72-9afbf47b76f1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53185-277-24	Chlorpheniramine maleate 4mg	24 in 1 BOTTLE	TABLET, COATED	24		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53185-277	CHLORPHENIRAMINE MALEATE 4MG TABLET, COATED [ATHLETE'S NEEDS, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20231020_4d974959-25fc-4707-9b72-9afbf47b76f1.zip

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 140 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
daytime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	e0e216ef-300c-4f57-87e6-62a5327e09b4	2024-11-08	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	969c0718-ba6e-4edb-9f55-43bc9500450f	2024-11-08	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	62a70d9a-4e78-497c-8f75-012ab94e92f6	2024-11-08	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Publix Super Markets Inc	25b2ad8a-5835-4496-815f-73a7fb40dcfd	2024-11-08	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	296f20c0-8b5f-4a08-9329-f93c92e63867	2024-11-08	Warnings	Exact identifier application number: M012
topcare tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Topco Associates LLC	d3cae69e-41a5-4099-a3f4-ce25fd94df73	2024-11-08	Warnings	Exact identifier application number: M012
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	9d147d1e-8ea5-4e0f-8ae8-1da16f119496	2024-11-08	Warnings	Exact identifier application number: M012
equate adult cough and chest congestion dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	WALMART INC.	e770bdb2-3662-4538-8199-fe4a4059c720	2024-11-08	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	23dcb627-c867-435f-9d1a-a9f49e58b58f	2024-11-08	Warnings	Exact identifier application number: M012
good neighbor pharmacy adult tussin DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	ced71993-f535-4e28-bc1d-3fcb7d86e9b7	2024-11-08	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS Pharmacy	2f1dc8f8-79c5-4724-99aa-a55330ed9d5f	2024-11-08	Warnings	Exact identifier application number: M012
good sense day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	4ac6b64a-8214-4b03-8aa5-0d3199cf0b72	2024-11-08	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	1dd9afb6-9b58-4274-a557-900a0cb23524	2024-11-08	Warnings	Exact identifier application number: M012
DG health sinus severe	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	7abaa912-be8b-463c-8818-104e79b33539	2024-11-07	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Cold Plus Flu Multi-Action Day	ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	7d3266dc-879a-4d28-b8ea-74d238c3020a	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	2ddb86a8-e34c-4a03-a60a-d3fedaf90608	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ce43e5c2-fe96-4462-882c-d7479318b33d	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL SINUS PLUS HEADACHE DAY	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e608d214-cc46-4a24-ac85-1040e36e7403	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	e83f7911-22b4-4ffc-8f49-68f6acd2ebf5	2024-11-07	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.	Kenvue Brands LLC	f81d924e-10e9-0e9d-e053-6294a90a2ddf	2024-11-07	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1363309	chlorpheniramine maleate 4 MG Oral Tablet	PSN	4d974959-25fc-4707-9b72-9afbf47b76f1	6
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	4d974959-25fc-4707-9b72-9afbf47b76f1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53185-277-24	53185027724	24 TABLET, COATED in 1 BOTTLE (53185-277-24)	2014-12-15	0000-00-00	No	No	Current