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 110 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Defensol D Blister Pack	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCI	Menper Distributors, Inc.	0dfcc977-6101-4536-e063-6294a90a7a48	2025-07-22	Warnings	Exact identifier application number: M012
Broncofin	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Menper Distributors, Inc.	fdf67382-1692-485b-92f1-2cbb8be4fb70	2025-07-22	Warnings	Exact identifier application number: M012
Defensol Adult Syrup	GUAIFENESIN, DEXTROMETHORPHAN HBR	Menper Distributors, Inc.	62acff69-8c40-4a0e-8d56-be2cc14e3d45	2025-07-22	Warnings	Exact identifier application number: M012
Cosedal Drops	DEXTROMETHORPHAN HBR, GUAIFENESIN	Menper Distributors, Inc.	1241d249-ea3b-4d2b-87ed-835d6a2d286a	2025-07-22	Warnings	Exact identifier application number: M012
Berro y Cebolla DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Menper Distributors, Inc.	20107bd9-6d84-4ab5-a0d9-966f1f11d919	2025-07-22	Warnings	Exact identifier application number: M012
Defensol-ito	DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE	Menper Distributors, Inc	a7c7a60d-d49f-4239-92f7-714eac7eb0c5	2025-07-22	Warnings	Exact identifier application number: M012
Bisolvine Children	GUAIFENESIN, DEXTROMETHORPHAN	MENPER DISTRIBUTORS INC.	896a5443-e3d2-4af7-9e27-f1c1899ce038	2025-07-22	Warnings	Exact identifier application number: M012
Bisolvine Aloe-Miel	DEXTROMETHORPHAN, GUAIFENESIN	MENPER DISTRIBUTORS INC.	34801c79-ce88-492f-808e-b639e8601607	2025-07-22	Warnings	Exact identifier application number: M012
Viva Porru Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Menper Distributors, Inc.	0dfadfe3-9e40-0eee-e063-6294a90a00c3	2025-07-22	Warnings	Exact identifier application number: M012
leader childrens allergy relief	DIPHENHYDRAMINE HCL	Cardinal Health 110, LLC. dba Leader	40d697b7-dc59-4d24-8d46-db635e01b9d5	2025-07-22	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Chain Drug Consortium	34005c55-3176-4f28-9a3b-7dc6fefd01fe	2025-07-19	Warnings	Exact identifier application number: M012
Sinus Relief Daytime Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	73a77a13-983b-4e65-bb3c-2ba5e9f33a3e	2025-07-19	Warnings	Exact identifier application number: M012
QUALITY CHOICE No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	7cb6ad04-7847-46b9-b371-0a3473001c79	2025-07-18	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	Chain Drug Consortium	270e9221-d305-4148-b523-741e02fe733f	2025-07-18	Warnings	Exact identifier application number: M012
ACTISPEC PSE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	5def1555-87f4-41d5-8a5c-be560aa8f1e2	2025-07-17	Warnings	Exact identifier application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	1a17b24a-8022-4e2f-e063-6294a90af276	2025-07-17	Warnings	Exact identifier application number: M012
BULPOL Smoking Patches	MENTHOL	Jiashen International Trade Limited	3a1cc0e1-fabf-52b9-e063-6394a90ae35e	2025-07-17	Warnings	Exact identifier application number: M012
Ampigrin Ultra Forte Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	e11e71c3-fe7c-77c7-e053-2995a90a34b2	2025-07-17	Warnings	Exact identifier application number: M012
Nitecin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	dfb56532-6f72-1e4d-e053-2a95a90a1c05	2025-07-17	Warnings	Exact identifier application number: M012
tabcin NIGHT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	0b3ed2bb-88ed-699e-e063-6394a90ac023	2025-07-17	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