ACTICON

Product NDC: 63102-401
11-digit product format: 631020401
Labeler code: 63102
Product ID: 63102-401_fa228895-52c1-44e7-b53c-fad106868c0d
Type: HUMAN OTC DRUG
Nonproprietary name: DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: ACTIPHARMA, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-08-13
Substance: DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 2; 60 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-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: ACTICON
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXBROMPHENIRAMINE MALEATE	2 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BPA9UT29BS	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1363513	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
847014ab-86ae-40c5-8e7f-f1ddea14f1b3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63102-401-60	2023-10-13	C162847	48780-1	0191ceaa-70e3-198a-e063-dbdaa90aec3e	ACTICON ® COLD & ALLERGY Tablets
63102-401-60	2023-07-28	C162847	48780-1	0191ceaa-70e3-198a-e063-dbdaa90aec3e	ACTICON ® COLD & ALLERGY Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63102-401-60	ACTICON	60 in 1 BOTTLE, PLASTIC	TABLET	60		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63102-401-60	EA - Each	63102-401	c2cee2a0-2d2e-46be-9bfa-4e990d78d77f	1	2016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXBROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	BPA9UT29BS	ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]	1
DEXBROMPHENIRAMINE	ACTIVE MOIETY	75T64B71RP	ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63102-401	ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20240814_847014ab-86ae-40c5-8e7f-f1ddea14f1b3.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 18 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus Congestion	PHENYLEPHRINE HCL	L.N.K. International, Inc.	81f0276a-99a2-4a57-a0d8-224735aa8c79	2026-07-10	Warnings	Exact identifier application number: M012
SINUS AND HEADACHE	ACETAMINOPHEN, PHENYLEPHRINE HCL	Rite Aid Corporation	efaf3be1-ab39-45f7-a45c-7fea8705c8d0	2026-07-10	Warnings	Exact identifier application number: M012
Equate Daytime Nighttime Vapor Ice Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WALMART INC.	f847d9f2-aa47-4bbe-8f06-19356c637398	2026-07-10	Warnings	Exact identifier application number: M012
Sinus and Allergy Relief PE	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Topco Associates, LLC	2a80fba9-5e30-4ec0-bd8e-8957c0654b6c	2026-07-10	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	50230cad-3d04-8882-e063-6294a90acf3c	2026-07-09	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Maximum Strength	ACETAMINOPHEN, PHENYLEPHRINE HCL	Rugby Laboratories	fc42e97d-1224-4d29-a55d-1a1885e0bf8f	2026-07-09	Warnings	Exact identifier application number: M012
Head Congestion and Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	7418d92d-a540-40d6-91d0-b7eb1f87f8ff	2026-07-08	Warnings	Exact identifier application number: M012
DG HEALTH COUGH AND CHEST CONGESTION	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dolgencorp Inc	5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d	2026-07-08	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Topco Associates, LLC	bfcabe02-7961-4407-a748-8cd087731398	2026-07-08	Warnings	Exact identifier application number: M012
Aller-chlor	CHLORPHENIRAMINE MALEATE	Rugby Laboratories	04ca3806-72be-47d4-9fea-5b0dee087683	2026-07-08	Warnings	Exact identifier application number: M012
nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	24c22c9f-0c2f-46dc-850e-ed05f00d3e95	2026-07-08	Warnings	Exact identifier application number: M012
NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	0e65c5d1-a18b-452c-9be6-8d44d34577e9	2026-07-08	Warnings	Exact identifier application number: M012
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	Cardinal Health 110, LLC. DBA Leader	aaecfda5-1a50-4d8a-9909-7153c1a22bda	2026-07-08	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	7cb9f378-5d64-475f-bf26-4058ba6c15b4	2026-07-08	Warnings	Exact identifier application number: M012
DG HEALTH DAY TIME INTENSE FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Dolgencorp Inc	f174d08e-3335-4cc9-8766-4070f18c4f31	2026-07-08	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN 400 MG	Health Pharma USA LLC	d60a3e9d-e88e-3b19-e053-2995a90a3e8d	2026-07-07	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	d38f47ea-7fda-170b-e053-2995a90adc82	2026-07-07	Warnings	Exact identifier application number: M012
Guaifenesin 200mg	GUAIFENESIN	Health Pharma USA LLC	d68222f7-b796-7b27-e053-2995a90a2efe	2026-07-07	Warnings	Exact identifier application number: M012
Cold and Flu Severe Day Time / Night Time	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	acdcc6ce-c190-4de6-b126-62fe9043112e	2026-07-07	Warnings	Exact identifier application number: M012
Calmco Allergy Relief	DIPHENHYDRAMINE HCL	CalmCo LLC	471b1a43-1708-8be7-e063-6394a90a9bb7	2026-07-06	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BPA9UT29BS	DEXBROMPHENIRAMINE MALEATE	2391-03-9	DEXBROMPHENIRAMINE MALEATE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1363513	dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG Oral Tablet	PSN	847014ab-86ae-40c5-8e7f-f1ddea14f1b3	6
1363513	dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet	SCD	847014ab-86ae-40c5-8e7f-f1ddea14f1b3	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63102-401-60	63102040160	60 TABLET in 1 BOTTLE, PLASTIC (63102-401-60)	60 tablet	2015-08-13	0000-00-00	No	No	Current