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 126 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Tussnex	ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	19e9678d-ac34-4af8-a80f-d08fce0a5f0e	2024-12-19	Warnings	Exact identifier application number: M012
Vaporising Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	New Pride Corp	f66476d5-036b-0b1c-e053-2a95a90a0a07	2024-12-19	Warnings	Exact identifier application number: M012
Chest Rub Vaporizing Action	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Singhfam Corporation	c6ea663a-9c4f-4d1a-a937-002806a8530a	2024-12-19	Warnings	Exact identifier application number: M012
ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION	CAMPHOR (SYNTHETIC), LEVOMENTHOL, EUCALYPTUS	Singhfam Corporation	f1e4caee-b50e-a0a6-e053-2a95a90aadce	2024-12-19	Warnings	Exact identifier application number: M012
Leader Vapor Steam camphor (synthetic)	CAMPHOR (SYNTHETIC)	LEADER/Cardinal Health 110, Inc.	ae580e6c-2efd-c788-e053-2995a90a3360	2024-12-19	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Strategic Sourcing Service, LLC	0b6689db-ea34-9a06-e063-6394a90abaf7	2024-12-19	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Jell Pharmaceuticals Pvt Ltd.	d80b9cc1-55f5-76d5-e053-2995a90aa967	2024-12-19	Warnings	Exact identifier application number: M012
Health Smart Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Home Smart Products	acab200e-48bd-69e1-e053-2995a90afde0	2024-12-19	Warnings	Exact identifier application number: M012
Halls MENTHO-LYPTUS	MENTHOL	Mondelez Global LLC	ff21cf0e-9811-4819-bdfc-17a950e9b114	2024-12-19	Warnings	Exact identifier application number: M012
Tussnex FM Cold, Flu and Sore Throat	ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	7bddce11-c227-4d95-94c1-6f41ecd7285b	2024-12-19	Warnings	Exact identifier application number: M012
Childrens Tussnex Multi-symptom cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	9028676e-d725-4afe-aa14-72235825aa17	2024-12-19	Warnings	Exact identifier application number: M012
Tussnex FM Cold and Sinus	ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	04c6bb6a-d2f8-4322-afba-e240e8090176	2024-12-19	Warnings	Exact identifier application number: M012
Tussnex FM Severe cough and congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	387df403-7803-4031-915e-8de9b103a162	2024-12-19	Warnings	Exact identifier application number: M012
Maximum strength Tussnex FM DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Guardian Drug Company	0bae53e3-9661-4bc6-9fcc-da7fa131b034	2024-12-19	Warnings	Exact identifier application number: M012
Vicks Vaposteam Lavender	CAMPHOR, (-)-	Kaz USA, Inc	03bf6b78-cf8e-44c6-bae0-5bd0a85f8aa9	2024-12-19	Warnings	Exact identifier application number: M012
Refenesen Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Reese Pharmaceutical Co	6046dc50-f162-4e2d-aa3c-7d27efad477d	2024-12-18	Warnings	Exact identifier application number: M012
Sunmark Chest Congestion Relief PE PE	GUAIFENESIN/PHENYLEPHRINE	Strategic Sourcing Services LLC	f94ae469-4c79-4ce9-9a3d-3bdc645be6d9	2024-12-18	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Chain Drug Marketing Association	1c33a01f-1186-4a19-b639-a9cd49245220	2024-12-18	Warnings	Exact identifier application number: M012
HealthMart Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	a5d1a8e8-10ba-4fff-b6f7-18c0fde5155c	2024-12-18	Warnings	Exact identifier application number: M012
DG Health Immediate Release Mucus Relief	GUAIFENESIN	Reese Pharmaceutical Co	f60a9d1b-7a63-43d3-b843-e1f31cf78873	2024-12-18	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