FDA.reportPublic FDA data

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
IngredientStrength
DEXBROMPHENIRAMINE MALEATE2 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BPA9UT29BSInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1363513Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
847014ab-86ae-40c5-8e7f-f1ddea14f1b3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63102-401-602023-10-13C16284748780-10191ceaa-70e3-198a-e063-dbdaa90aec3eACTICON ® COLD & ALLERGY Tablets
63102-401-602023-07-28C16284748780-10191ceaa-70e3-198a-e063-dbdaa90aec3eACTICON ® COLD & ALLERGY Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-401-60ACTICON60 in 1 BOTTLE, PLASTICTABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63102-401-60EA - Each63102-401c2cee2a0-2d2e-46be-9bfa-4e990d78d77f12016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXBROMPHENIRAMINE MALEATEACTIVE INGREDIENTBPA9UT29BSACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]1
DEXBROMPHENIRAMINEACTIVE MOIETY75T64B71RPACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63102-401ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [ACTIPHARMA, LLC]5Current NDC, Legacy NDC, 1 package rows20240814_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 11 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORIGINAL Nasal PUMP MIST No DripOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLCac27fd75-4fe4-433c-a434-2dac16c895c72026-08-07WarningsExact identifier
application number: M012
Winco Foods Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLCa1367804-37c9-4906-858f-8feeb748d8d32026-08-07WarningsExact identifier
application number: M012
Severe Congestion Nasal Anti-Drip Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLCa09c2d02-334a-4840-b2d0-327121cec9942026-08-07WarningsExact identifier
application number: M012
Daytime Nighttime Intense Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company03aa43fd-4962-4c2c-9edd-e422a629a0e32026-08-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf311b56f-b959-4070-9b23-82c642dd98b82026-08-06WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.2ed25f69-89ef-4c50-946a-7e7b9df1ca8a2026-08-06WarningsExact identifier
application number: M012
EucamintMENTHOL, CAMPHORIndiana Botanic Gardensd79bc8de-9efb-4996-a55c-accda0f8edb22026-08-06WarningsExact identifier
application number: M012
NICOTINE GUMNICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.4e88dab4-8e13-f074-e063-6394a90a39082026-08-06WarningsExact identifier
application number: M012
Oneoo Nicotine Gum (Mint)NICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.54b1329b-b422-29a5-e063-6294a90a87802026-08-06WarningsExact identifier
application number: M012
Sine Aid PEAK MISERYOXYMETAZOLINE HYDROCHLORIDEInfirst Healthcare Inc.586a2a14-7048-0c8b-e063-6394a90a65b72026-08-06WarningsExact identifier
application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERaritan Pharmaceuticals Incb745f45d-2042-4daa-9932-241836d7734b2026-08-06WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
application number: M012
Daytime Cold, Nighttime Cold multi-symptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI3b462a5d-d48b-4b73-b5d4-d7944730bbdd2026-08-06WarningsExact identifier
application number: M012
TOPCARE DAY TIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLCd1b89d17-b3b9-4133-88a3-8cd7c4efafa92026-08-05WarningsExact identifier
application number: M012
Sinufrin Quick Relief DecongestantSINUFRINNeilmed pharmaceuticals Inc.0c36a34e-462d-713c-e063-6294a90a17762026-08-05WarningsExact identifier
application number: M012
No DripOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Ince9b799ad-9164-7f30-e053-2a95a90a00c52026-08-05WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Fast DissolveCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.507284c3-cad9-d65c-e063-6394a90a58a82026-08-05WarningsExact identifier
application number: M012
cough and cold relief HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRUnited Natural Foods, Inc. dba UNFI90482e7a-d7c7-4127-972d-5ee55e55ed1c2026-08-04WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Company78edeb7a-4712-4f04-9d76-d5b2d20ce76d2026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRBetter Living Brands, LLC33f34aa2-3b37-4e51-8428-4a12708aa0642026-08-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363513dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG Oral TabletPSN847014ab-86ae-40c5-8e7f-f1ddea14f1b36
1363513dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD847014ab-86ae-40c5-8e7f-f1ddea14f1b36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63102-401-606310204016060 TABLET in 1 BOTTLE, PLASTIC (63102-401-60) 60 tablet2015-08-130000-00-00NoNoCurrent