ACTIDOM DA

Product NDC: 63102-115
11-digit product format: 631020115
Labeler code: 63102
Product ID: 63102-115_e2d0fae5-74da-4a40-8e64-708a3d237ea8
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine maleate, Phenylephrine hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: ACTIPHARMA, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-01-20
Substance: CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 1; 2.5 mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: ACTIDOM DA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPHENIRAMINE MALEATE	1 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1Q0O9OJ9Z	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
1429345	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
7797c22e-ffeb-4798-9fb6-aa64cf077ba7	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
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
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
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
63102-115-16	ACTIDOM DA	474 mL in 1 BOTTLE, PLASTIC	SOLUTION	474		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63102-115	ACTIDOM DA (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20240809_7797c22e-ffeb-4798-9fb6-aa64cf077ba7.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 172 of 174 · 3,464 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	0d65c4a9-938c-4a89-b1f1-d9ada8a8c587	2023-10-10	Warnings	Exact identifier application number: M012
Triacting Daytime Cold Cough Childrens	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8656aa2e-9546-4de4-9ecc-ce99bf903333	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief All in One Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL	Walgreens	a33ae35b-1cde-4a3d-a836-3b169e4f1bb9	2023-10-10	Warnings	Exact identifier application number: M012
Severe Cold and Cough Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	553d01a9-e8ad-4797-b55b-32f134f08af9	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief Maximum StrengthCold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	8781e2c5-ad46-4615-a0d9-879590e86f95	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief All in One Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	419df833-1f33-45cf-bab3-730c928d5887	2023-10-10	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	93a5cb36-3262-4224-a5be-5ea1619a67bd	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN	CVS Pharmacy	782fb103-cd9f-4e8c-8f3a-1fb131b9eda6	2023-10-09	Warnings	Exact identifier application number: M012
Cold and Congestion Childrens Nighttime	DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL	Walgreens	a7847413-e556-4f88-8a7f-a8528afbe927	2023-10-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	06d2c6cf-0adb-91b9-e063-6294a90aff52	2023-10-03	Warnings	Exact identifier application number: M012
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Lil' Drug Store Products, Inc.	e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b	2023-10-02	Warnings	Exact identifier application number: M012
Guaifenesin DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	PD-Rx Pharmaceuticals, Inc.	ac8c0c15-b305-47f2-8712-e4b53636f7fa	2023-10-02	Warnings	Exact identifier application number: M012
Maximum strength Day cold and flu and Night severe cold and flu	ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS	TIME CAP LABORATORIES,INC	fff69901-965c-5372-e053-6394a90a29c2	2023-09-18	Warnings	Exact identifier application number: M012
Tussin Mucus and Chest Congestion Sugar Free	GUAIFENESIN	AARNA USA, Inc.	6e488782-0138-436d-a9f0-0ec5bc9daedd	2023-05-15	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	KROGER COMPANY	813b1db2-a177-77c6-e053-2a91aa0ac73b	2023-01-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	DEXTROMETHORPHAN HBR/GUAIFENESIN	KROGER COMPANY	813baf42-edb0-33a9-e053-2a91aa0a8599	2023-01-17	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H-E-B	db19b8c7-0334-0664-e053-2a95a90ad61f	2023-01-14	Warnings	Exact identifier application number: M012
Nightime	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	H-E-B	db44560b-da02-74c9-e053-2a95a90af0b6	2023-01-13	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	dbf5656b-9105-871b-e053-2995a90a4941	2023-01-03	Warnings	Exact identifier application number: M012
DAYTIME-NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	KROGER	a2508699-08c0-4a22-e053-2a95a90a8a6d	2022-11-02	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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1429345	chlorpheniramine maleate 1 MG / phenylephrine hydrochloride 2.5 MG in 5 mL Oral Solution	PSN	7797c22e-ffeb-4798-9fb6-aa64cf077ba7	2
1429345	chlorpheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	7797c22e-ffeb-4798-9fb6-aa64cf077ba7	2
1429345	chlorpheniramine maleate 1 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	7797c22e-ffeb-4798-9fb6-aa64cf077ba7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63102-115-16	63102011516	474 mL in 1 BOTTLE, PLASTIC (63102-115-16)	474 ml	2022-01-20	0000-00-00	No	No	Current