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 17 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Viro-Flu AM	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	OPMX LLC	551c957a-2e44-2b17-e063-6394a90a5295	2026-07-15	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	1f93fe6d-ee21-e323-e063-6394a90a61bf	2026-07-15	Warnings	Exact identifier application number: M012
Pentrexcilina Daytime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b7b3c15a-bb28-5c25-e053-2a95a90ad3b1	2026-07-15	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	1f93c815-63c7-bfe0-e063-6394a90ab4a5	2026-07-15	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	WALMART INC. (see also Equate)	28251229-ad84-4573-aff0-fb0bed6cdfa1	2026-07-15	Warnings	Exact identifier application number: M012
Viro Flu PM Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	5693f346-8214-0112-e063-6394a90aabfb	2026-07-14	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	5fa848ef-35ee-4e05-8ff2-781d034cf6ac	2026-07-14	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Cardinal Health 110, LLC. DBA Leader	0fad61d8-4393-47ec-9ff6-7df5be761f5b	2026-07-14	Warnings	Exact identifier application number: M012
Sinus and Allergy Relief PE	CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	Rite Aid Corporation	211c4273-3b2c-4169-b9c6-7a87903e77cd	2026-07-13	Warnings	Exact identifier application number: M012
Flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Rite Aid Corporation	f1a4ee57-33a3-4791-a769-b208b38acb72	2026-07-13	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY Childrens Allergy Relief	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	c499574c-f32b-4608-bf8b-51ad44e35725	2026-07-13	Warnings	Exact identifier application number: M012
Good NeighborChildrens Allergy Relief Bubblegum flavor	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	f442c61b-7d2c-401c-b862-acbe2282927b	2026-07-13	Warnings	Exact identifier application number: M012
Sanatos	MENTHOL	Pharmadel LLC	5683b099-f029-2d08-e063-6394a90ad482	2026-07-13	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f673cdeb-4f8b-46b4-be92-c725d74abc55	2026-07-13	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	e4fca5ba-2d45-4c38-b0fd-297159d1705a	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	AMERISOURCE BERGEN	0269c0fd-0d8f-4264-9025-d4dcb3c45c60	2026-07-13	Warnings	Exact identifier application number: M012
Propolis Cooling Relief Cherry Cough Drops	MENTHOL, UNSPECIFIED FORM	Beekeeper's Naturals USA Inc	7087566d-f24a-4508-aa25-7f42d055c43e	2026-07-13	Warnings	Exact identifier application number: M012
Sinus Pressure and Congestion Relief	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Rite Aid Corporation	35bcf263-3296-4d9c-84c0-146a173d6e87	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Childrens Cough Relief Cherry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	AMERISOURCE BERGEN	a8e2fd43-b801-41ae-8d79-8ecf4a771543	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor No Drip Nasal Mist Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	AMERISOURCE BERGEN	7872aadd-b23c-431f-8048-24eece25ca2d	2026-07-13	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