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 172 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Sinus Maxium Strength	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	6e5ca8e1-5a03-4e77-b385-d44387fb3bfc	2023-12-29	Warnings	Exact identifier application number: M012
Cold, Flu and Sore Throat Maxium Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	d98029c0-ccd9-47e1-996f-c7786cd4ecca	2023-12-29	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH Sinus Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	0f2be061-bd0a-4e62-b994-6d0768ea647a	2023-12-29	Warnings	Exact identifier application number: M012
Tussin CF Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	c19b9997-4037-48f3-b905-86da421a292d	2023-12-29	Warnings	Exact identifier application number: M012
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	0239ada0-644d-4ef4-a3b8-df70246a3bc2	2023-12-21	Warnings	Exact identifier application number: M012
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	a698502d-c1c5-41ca-8142-74338b834c8b	2023-12-21	Warnings	Exact identifier application number: M012
Father Johns Cough Medicine Plus	NASAL DECONGESTANT	Oakhurst Company	8b8aab0f-251b-6bd8-e053-2995a90ad748	2023-12-18	Warnings	Exact identifier application number: M012
Father Johns Medicine	DEXTROMETHORPHAN HBR	Oakhurst Company	8b8a249d-55af-cc98-e053-2995a90a431d	2023-12-18	Warnings	Exact identifier application number: M012
Daytime Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e79d92d2-d73c-d44f-e053-2995a90a03d9	2023-12-15	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL TABLET	Lil' Drug Store Products, Inc.	e5339c39-1d66-b283-e053-2995a90a4317	2023-12-15	Warnings	Exact identifier application number: M012
Father Johns Medicine	DEXTROMETHORPHAN HBR	Humco Holding Group, Inc	a7b0669f-8da1-5a44-e053-2995a90a84d9	2023-12-15	Warnings	Exact identifier application number: M012
Ephedrine Hydrochloride	EPHEDRINE HYDROCHLORIDE	Walgreen Company	bcb81dc1-d854-30c0-e053-2a95a90a9fc7	2023-12-14	Warnings	Exact identifier application number: M012
Allergy, Circle K	DIPHENHYDRAMINE HCL 25MG TABLET	Lil' Drug Store Products, Inc.	d1f370ac-e7f4-baf7-e053-2995a90a1e50	2023-12-14	Warnings	Exact identifier application number: M012
Circle K Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	a6a1e3d9-575c-4adf-beb6-c9719de55c67	2023-12-14	Warnings	Exact identifier application number: M012
Non-Drowsy Sinus Severe, Circle K	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED	Lil' Drug Store products, Inc.	e78c456f-f62e-596d-e053-2995a90a2397	2023-12-14	Warnings	Exact identifier application number: M012
Non-Drowsy Max Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e79f1a92-d8ea-e3f9-e053-2a95a90a2d37	2023-12-14	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Major Pharmaceuticals	bcc1a001-4176-485d-aaf0-2037ca65c6b8	2023-12-14	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Major Pharmaceuticals	edb49b17-06a7-4c25-bc7c-d62c1deac7f1	2023-12-13	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline No Drip	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	0c006b1c-8ab2-4b9c-8738-e7001c1bb47d	2023-12-11	Warnings	Exact identifier application number: M012
Daytime Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORP	0b1e230d-4354-bf61-e063-6394a90a2b2f	2023-12-09	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