dimaphen dm

Product NDC: 0904-6463
11-digit product format: 009046463
Labeler code: 0904
Product ID: 0904-6463_ae06d085-220b-4bc6-8239-3917ee97d9ac
Type: HUMAN OTC DRUG
Nonproprietary name: Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-09-11
Marketing end: 2026-11-30
Substance: BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 2; 10; 5 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
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: dimaphen dm

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BROMPHENIRAMINE MALEATE	2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IXA7C9ZN03	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090463	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
67072a38-1ae7-4e59-bfed-71db0d93215d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6463-20	dimaphen dm	118 mL in 1 BOTTLE	SOLUTION	118		6
0904-6463-20	dimaphen dm	1 in 1 CARTON	SOLUTION	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6463-20	ML - Milliliter	0904-6463	c5139294-a0e9-4687-bc5f-503556c4b2bf	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	IXA7C9ZN03	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6463	DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 2 package rows	20241119_67072a38-1ae7-4e59-bfed-71db0d93215d.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 10 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIPROLIDINE HYDROCHLORIDE	TRIPROLIDINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	4eeffb6d-fc5e-48bc-95f6-ec4d5cb6e0d2	2026-08-10	Warnings	Exact identifier application number: M012
TRIPROLIDINE HYDROCHLORIDE	TRIPROLIDINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	a9f01760-e335-4410-a9b8-8edce2841270	2026-08-10	Warnings	Exact identifier application number: M012
Guaifed	GUAIFENESIN	Aldama Pharmaceuticals, Inc	38f37272-2084-a33b-e063-6294a90ac150	2026-08-10	Warnings	Exact identifier application number: M012
Chlorpheniramine Maleate	CHLORPHENIRAMINE MALEATE	PD-Rx Pharmaceuticals, Inc.	7a3452a2-930f-48b1-8c59-dbceb10b9c78	2026-08-10	Warnings	Exact identifier application number: M012
Guaifed DM	DEXTROMETHORPHAN, GUAIFENESIN	Aldama Pharmaceuticals, Inc	396bf716-0f61-9563-e063-6394a90a171b	2026-08-10	Warnings	Exact identifier application number: M012
Daytime Cold and Flu mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	eff114fe-fb15-48dd-b673-4d4d66406e69	2026-08-10	Warnings	Exact identifier application number: M012
Sleep Aid	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	651b03a3-b85e-4028-a9f2-472bec16c8f4	2026-08-10	Warnings	Exact identifier application number: M012
NASAL	PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	02a89765-2a75-470a-9fd6-8cce71dc19e9	2026-08-10	Warnings	Exact identifier application number: M012
WINCO Maximum StrengthCold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WINCO FOODS, LLC	f34bfb71-2c81-44d0-a2a0-4d320c43c217	2026-08-07	Warnings	Exact identifier application number: M012
DAYTIME NIGHTTIME ELDERBERRY COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreen Company	11cac20e-9bb6-4e2d-8efd-4451f055c7b4	2026-08-07	Warnings	Exact identifier application number: M012
Winco Foods Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WINCO FOODS, LLC	1d02b32a-e88d-4c70-b66d-7bdc22c25a43	2026-08-07	Warnings	Exact identifier application number: M012
foster and thrive daytime cold and flu relief nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	c1ecc56b-8052-4b0a-900a-dc93a24771bd	2026-08-07	Warnings	Exact identifier application number: M012
Adult Long Lasting Cough Relief	DEXTROMETHORPHAN HBR	Shield Pharmaceuticals Corp	bbf7d296-fa3d-43e5-984c-e9d2881a074d	2026-08-07	Warnings	Exact identifier application number: M012
Severe Cold and Cough Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	WinCo Foods, LLC	790d534a-0f40-495b-a815-67851ac3d20d	2026-08-07	Warnings	Exact identifier application number: M012
Extra Moisturizing Nasal Pump Mist Anti Drip	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	46ebd262-c6a4-43ea-a7f6-506561bb3de4	2026-08-07	Warnings	Exact identifier application number: M012
Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	WINCO FOODS, LLC	e6afa830-6ce2-4abc-b5c9-3f5f156444df	2026-08-07	Warnings	Exact identifier application number: M012
Sinus PE Pressure plus Pain MAXIMUM STRENGTH	ACETAMINOPHEN, PHENYLEPHRINE HCL	CVS Pharmacy	a3b073b4-494c-4531-b08e-475c86ba321d	2026-08-07	Warnings	Exact identifier application number: M012
Severe Cold and Cough Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	WinCo Foods, LLC	dc56197c-c108-4b35-b791-dde5c3384ddd	2026-08-07	Warnings	Exact identifier application number: M012
Sinus Severe Non Drowsy, Daytime	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	84c30ec9-a7b5-4d2f-95b2-d6fb895945de	2026-08-07	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	887cabe5-46d0-4f4e-8f5a-2cfdbc157b58	2026-08-07	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IXA7C9ZN03	BROMPHENIRAMINE MALEATE	980-71-2	BROMPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1090463	brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	67072a38-1ae7-4e59-bfed-71db0d93215d	6
1090463	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	67072a38-1ae7-4e59-bfed-71db0d93215d	6
1090463	brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	67072a38-1ae7-4e59-bfed-71db0d93215d	6
1090463	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	67072a38-1ae7-4e59-bfed-71db0d93215d	6
1090463	brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	da148c1d-e394-4367-83e0-533469501b30	2
1090463	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	da148c1d-e394-4367-83e0-533469501b30	2
1090463	brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	da148c1d-e394-4367-83e0-533469501b30	2
1090463	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	da148c1d-e394-4367-83e0-533469501b30	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6463-20	00904646320	1 BOTTLE in 1 CARTON (0904-6463-20) / 118 mL in 1 BOTTLE	1 bottle	2006-09-11	2026-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals Children’s Dimaphen DM Drug Facts	Preferred Pharmaceuticals Inc.	2026-04-06	HUMAN OTC DRUG LABEL	2
Major Pharmaceuticals Children’s Dimaphen DM Drug Facts	Major Pharmaceuticals	2026-02-25	HUMAN OTC DRUG LABEL	6
Major Pharmaceuticals Children’s Dimaphen™ DM Drug Facts	Preferred Pharmaceuticals Inc.	2020-05-05	HUMAN OTC DRUG LABEL	3