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 5 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maximum Strength Mucus Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Hyvee Inc	4e578c7a-88d4-e4cd-e063-6394a90aac44	2026-08-27	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	5afb242f-fac9-dc81-e063-6394a90a8448	2026-08-27	Warnings	Exact identifier application number: M012
daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Amazon.com Services LLC	6de619d3-0ab0-43e7-8dac-7bbd5368ac65	2026-08-27	Warnings	Exact identifier application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI	Walgreens	366ddac8-9e8a-41bd-a7f7-48213485a5f8	2026-08-27	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Walgreens	37896933-3ed3-457f-8a32-ee0d784a19e8	2026-08-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Amazon.com Services LLC	298e9164-e378-4b39-a944-bfc8f8baa4de	2026-08-27	Warnings	Exact identifier application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum Strength	DAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Walgreens	3b4b3b04-eff9-4e06-8b37-f6729671d07f	2026-08-27	Warnings	Exact identifier application number: M012
Daytime Cold and Flu mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	dfb0fe2e-b0c7-409a-bd1a-fd12485665ba	2026-08-26	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	70c5517d-be4e-4317-b4f4-df660c71c699	2026-08-26	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d	2026-08-26	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	5b95905e-b729-4caf-921a-fc4ef815289c	2026-08-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	c88e93d4-66b6-4327-b9e5-0e0a95a18d66	2026-08-25	Warnings	Exact identifier application number: M012
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4fff664b-4ff0-4007-95ab-cb273807b9b4	2026-08-25	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	464534ee-15f8-3af8-e063-6394a90a3f18	2026-08-24	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	7d972559-6184-476b-9cbf-1bc5663ea00d	2026-08-24	Warnings	Exact identifier application number: M012
Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	9be8437c-6053-4ed4-bdd2-97f556b5289e	2026-08-24	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE	Kenvue Brands LLC	594f515c-b369-816d-e063-6294a90a59a1	2026-08-21	Warnings	Exact identifier application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, LLC	47ddbb0d-0823-4817-9c56-e7fff77d601c	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	DOLGENCORP, LLC	5be4e730-3cd6-414e-a23b-f6cad8088750	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Cardinal Health 110, LLC. DBA Leader	6304a581-9238-4539-b157-293fc05c173e	2026-08-21	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