DOMETUSS

Product NDC: 53809-222
11-digit product format: 538090222
Labeler code: 53809
Product ID: 53809-222_897f949d-5437-4419-a6c3-206778dbf45d
Type: HUMAN OTC DRUG
Nonproprietary name: chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: Domel Laboratories
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-03-06
Substance: CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 2; 10; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53809-222-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53809-222-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53809-222-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53809-222-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53809-222-04	`cdf11ea48f46…`	`ba0047e9e063…`

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: DOMETUSS
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1Q0O9OJ9Z	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
1363752	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
3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe	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
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
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
53809-222-04	DOMETUSS	118 mL in 1 BOTTLE	LIQUID	118		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53809-222	DOMETUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DOMEL LABORATORIES]	2	Current NDC, 1 package rows	20241207_3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe.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 158 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Herbal Flavor Menthol Cough Drops	HERBAL FLAVOR MENTHOL COUGH DROPS	WHOLE FOODS MARKET, INC.	1eb848b6-3dec-5b5f-e063-6394a90aea14	2024-08-02	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL COUGH DROPS	WHOLE FOODS MARKET, INC.	1eb8927b-22c5-2ca3-e063-6294a90aa563	2024-08-02	Warnings	Exact identifier application number: M012
No Drip Severe Anefrin Nasal	0.05% OXYMETAZOLINE HCL	Walgreens Company	c126e969-56f3-47b4-a011-02ff150eccb8	2024-08-02	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	90e0426b-654f-4bcd-8b1d-cf56d1fc0c68	2024-07-27	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HCL	A-S Medication Solutions	0e81a937-59e5-4869-8ffb-c758fb37230d	2024-07-23	Warnings	Exact identifier application number: M012
WesTussin DM	DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Westminster Pharmaceuticals, LLC	68a0cd44-3fdd-430e-af1a-498d4415ab78	2024-07-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Lil' Drug Store Products, Inc.	edc244d6-eb0b-d3c9-e053-2a95a90a2622	2024-07-22	Warnings	Exact identifier application number: M012
Night Time Sleep Aid	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	1f3eeb6c-4c44-4e2a-ad72-12c95e6589c9	2024-07-22	Warnings	Exact identifier application number: M012
CareOne Childrens Allergy Relief	DIPHENHYDRAMINE HCL	American Sales Company	bb78ef2c-4f42-4e8f-b38d-f9b2965a384b	2024-07-19	Warnings	Exact identifier application number: M012
dg health allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, LLC	71445443-34bd-4d8c-b9c8-e7c3b8d4c832	2024-07-19	Warnings	Exact identifier application number: M012
basic care childrens allergy relief	DIPHENHYDRAMINE HCL	Amazon.com Services LLC	75b9ee90-ad26-433e-8b90-97441b8d1e15	2024-07-19	Warnings	Exact identifier application number: M012
Cold and Flu Severe Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC	9b74dd00-8f84-4fce-b5ea-df886b595326	2024-07-18	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	4872dfdd-0df6-47ae-87f2-8049191cd482	2024-07-18	Warnings	Exact identifier application number: M012
equate allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	b05acd16-21cb-4ee0-afa0-8f7d59166435	2024-07-18	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Publix Super Markets Inc	cc6e4e26-84f5-4003-b1eb-f0e06d3e294e	2024-07-18	Warnings	Exact identifier application number: M012
childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Kroger Company	10ebc7f8-dc8a-4640-8f87-d0d073998fd5	2024-07-18	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Amerisource Bergen	b173cc2c-7c4c-4f9e-a920-c71bc256ec1e	2024-07-18	Warnings	Exact identifier application number: M012
ALLERGY	CHLORPHENIRAMINE MALEATE	A-S Medication Solutions	b199b5ee-fff3-4746-be68-a04060586f8e	2024-07-18	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	H E B	2d1715b3-b1cf-455d-9909-f6d58c97db40	2024-07-18	Warnings	Exact identifier application number: M012
careone allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	American Sales Company	ed4038fc-ab39-4567-9961-2b390b91b126	2024-07-17	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
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
1363752	chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution	PSN	3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe	4
1363752	chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution	SCD	3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe	4
1363752	chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution	SY	3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53809-222-04	53809022204	118 mL in 1 BOTTLE (53809-222-04)	118 ml	2024-03-06	No	No	Current