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 168 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	3dc293c9-736b-4bd8-b993-ff83b9909bcd	2024-02-23	Warnings	Exact identifier application number: M012
Childrens Dibromm Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Cardinal Health (Leader) 70000	10cc7d67-30c4-4451-bf74-78abae3c8e25	2024-02-23	Warnings	Exact identifier application number: M012
Nasal Spray, 24-7 for Life	OXYMETAZOLINE HYDROCHLORIDE 0.05%	Lil' Drug Store Products, Inc.	11d27c75-fd95-f9da-e063-6394a90ac6b0	2024-02-20	Warnings	Exact identifier application number: M012
Nighttime Cold and Cough childrens	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	11652e8a-2242-4449-8a41-a8e75509025e	2024-02-20	Warnings	Exact identifier application number: M012
Severe Sinus Relief Mist	OXYMETAZOLINE SPRAY	Walgreens Company	847f47d9-62b1-49a3-8bb3-9bf275685bd2	2024-02-14	Warnings	Exact identifier application number: M012
Allergy Sinus, Lil Drug Store	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE	Lil' Drug Store Products, Inc.	1145440e-b37a-6e5e-e063-6294a90ab4a0	2024-02-13	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	A-S Medication Solutions	36140639-e7a8-43bc-83e2-469430af9d1a	2024-02-13	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	ff48b55a-0d32-47d6-941d-d99c7cf52f94	2024-02-12	Warnings	Exact identifier application number: M012
Childrens Robitussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	15950273-14c9-4a0b-bbb4-683048add722	2024-02-08	Warnings	Exact identifier application number: M012
THERAFLU Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	7d902237-a990-4c5e-875b-291e124e143b	2024-02-03	Warnings	Exact identifier application number: M012
Tussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Best Choice (Valu Merchandisers Company)	0f2d371d-f890-41e5-ac11-db5559d32466	2024-02-02	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	4daca846-8511-4303-9e6c-9469f7f260ba	2024-02-02	Warnings	Exact identifier application number: M012
CVS Health COUGH SUPPRESSANT SOFTGEL	DEXTROMETHORPHAN HYDROBROMIDE	CVS Pharmacy, Inc.	f676dfeb-fba8-419d-8a47-c3880e4100cc	2024-02-02	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu ReadyInCase	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	155a7168-b568-41f4-b8a2-214889b4eccf	2024-02-02	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	Rejoice International Corp.	104e1a38-3472-b9e2-e063-6294a90a38cf	2024-02-01	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	China Ningbo Shangge Cosmetics Technology Corp.	104f5b07-eed2-566c-e063-6294a90a6505	2024-02-01	Warnings	Exact identifier application number: M012
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	5962a73e-72e4-493b-94a7-43bc6cf9c82f	2024-02-01	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2024-01-31	Warnings	Exact identifier application number: M012
SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	17a07d2d-f2da-4e51-9a77-6f0c174987bb	2024-01-31	Warnings	Exact identifier application number: M012
Maximum strength Max Cold and Sinus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	263dae13-5f92-4505-8bcc-e903d05b9a0c	2024-01-31	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