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 141 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	8b516736-86ac-47cb-a0ec-038d4c3a0020	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu plus Cough Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e85e5eb9-3ecf-4784-999e-111e38e306f5	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ef8a846d-4b29-4fd8-a683-fada04d0a2b9	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	9761c807-75a1-4498-a8c6-1f2b1c9ffde6	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Mucus Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	24ac94e8-b223-424e-bcd2-9c027c8ff9ed	2024-11-07	Warnings	Exact identifier application number: M012
Primatene	EPHEDRINE HYDROCHLORIDE	Foundation Consumer Brands	2170f081-c03f-47e8-bc63-4052c5e653fa	2024-11-07	Warnings	Exact identifier application number: M012
Rompe Pecho Max Multi Symptoms	ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN	EFFICIENT LABORATORIES INC	938e4e47-d2d9-4b0d-bf88-e9f41b501945	2024-11-07	Warnings	Exact identifier application number: M012
topcare sinus nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	ca1fefed-e9d7-430a-9da4-972b1a6fb786	2024-11-07	Warnings	Exact identifier application number: M012
Leader Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	dd82a389-9ec5-4b3f-a9ea-1a56871ebd17	2024-11-07	Warnings	Exact identifier application number: M012
topcare day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	1a8e2e03-e11b-4da1-945b-e2caadea7243	2024-11-07	Warnings	Exact identifier application number: M012
SUDOGEST NASAL DECONGESTANT	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	09feb5f0-c22d-4a1b-97a0-d5767e5f7730	2024-11-07	Warnings	Exact identifier application number: M012
up and up childrens allergy melts	DIPHENHYDRAMINE HCL	Target Corporation	f98d1d54-8e11-4bb1-825a-ab5447d37847	2024-11-07	Warnings	Exact identifier application number: M012
good sense severe day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	44130a1b-63cc-42ac-9590-fdf21a12d164	2024-11-07	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	a5ff1134-8985-4585-8e61-a5fd5f60afeb	2024-11-07	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	50528d29-ce8c-4efb-a86c-17246b017db0	2024-11-07	Warnings	Exact identifier application number: M012
cooling severe daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy	d4a21760-b2bd-4e26-bff0-6fc1b05d26b3	2024-11-07	Warnings	Exact identifier application number: M012
dg health day time severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	60870311-3234-44ba-95dd-09cf4ea3d508	2024-11-07	Warnings	Exact identifier application number: M012
adult dm max cough and chest congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Meijer Distribution Inc	3a6855c1-da6d-4fa9-81fe-d2e61355989f	2024-11-06	Warnings	Exact identifier application number: M012
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	e51dfb62-40d0-4bec-9574-90057cb35bcc	2024-11-06	Warnings	Exact identifier application number: M012
Foster and Thrive Adult Tussin DM MAX	DEXTROMETHORPHAN HBR, GUAIFENESIN	Strategic Sourcing Services LLC	5f6e4d56-4a66-4dbd-97c8-550310dea358	2024-11-05	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