FDA.reportPublic FDA data

Rycontuss

Product NDC
65852-021
11-digit product format
658520021
Labeler code
65852
Product ID
65852-021_41afb883-1159-9764-e063-6294a90a1712
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Dextrum Laboratories, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-05-31
Substance
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
5; 2; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Rycontuss
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL
CHLORPHENIRAMINE MALEATE2 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
V1Q0O9OJ9ZInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1363752Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41afb883-1158-9764-e063-6294a90a1712Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-021-16Rycontuss473 mL in 1 BOTTLE, PLASTICLIQUID4731

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 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEWinCo Foods, LLCdc56197c-c108-4b35-b791-dde5c3384ddd2026-08-07WarningsExact identifier
application number: M012
Sinus Severe Non Drowsy, DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.84c30ec9-a7b5-4d2f-95b2-d6fb895945de2026-08-07WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC887cabe5-46d0-4f4e-8f5a-2cfdbc157b582026-08-07WarningsExact identifier
application number: M012
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN41afb883-1158-9764-e063-6294a90a17121
1363752chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD41afb883-1158-9764-e063-6294a90a17121
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY41afb883-1158-9764-e063-6294a90a17121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65852-021-1665852002116473 mL in 1 BOTTLE, PLASTIC (65852-021-16) 473 ml2011-05-31NoNoCurrent