FDA.reportPublic FDA data

Rycontuss

Product NDC
76117-001
11-digit product format
761170001
Labeler code
76117
Product ID
76117-001_2920bd2e-29f6-9847-e063-6394a90a4fde
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Okendpharma, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-05-31
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2; 10; 5 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
Brand name suffix
Cherry Flavor
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal 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
c91798fa-48ab-47a0-92da-4d44c2aafde0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76117-001-16RycontussCherry Flavor473 mL in 1 BOTTLELIQUID4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76117-001-16ML - Milliliter76117-001faa8a08d-4cf3-4b6c-a39f-3ec233d3e20412014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZRYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHRYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJRYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965URYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSRYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVRYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPRYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LRYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TRYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHRYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRRYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554RYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RRYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76117-001RYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]5Current NDC, Legacy NDC, 1 package rows20241215_c91798fa-48ab-47a0-92da-4d44c2aafde0.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 10 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIPROLIDINE HYDROCHLORIDETRIPROLIDINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC4eeffb6d-fc5e-48bc-95f6-ec4d5cb6e0d22026-08-10WarningsExact identifier
application number: M012
TRIPROLIDINE HYDROCHLORIDETRIPROLIDINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa9f01760-e335-4410-a9b8-8edce28412702026-08-10WarningsExact identifier
application number: M012
GuaifedGUAIFENESINAldama Pharmaceuticals, Inc38f37272-2084-a33b-e063-6294a90ac1502026-08-10WarningsExact identifier
application number: M012
Chlorpheniramine MaleateCHLORPHENIRAMINE MALEATEPD-Rx Pharmaceuticals, Inc.7a3452a2-930f-48b1-8c59-dbceb10b9c782026-08-10WarningsExact identifier
application number: M012
Guaifed DMDEXTROMETHORPHAN, GUAIFENESINAldama Pharmaceuticals, Inc396bf716-0f61-9563-e063-6394a90a171b2026-08-10WarningsExact identifier
application number: M012
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpeff114fe-fb15-48dd-b673-4d4d66406e692026-08-10WarningsExact identifier
application number: M012
Sleep AidDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)651b03a3-b85e-4028-a9f2-472bec16c8f42026-08-10WarningsExact identifier
application number: M012
NASALPHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC02a89765-2a75-470a-9fd6-8cce71dc19e92026-08-10WarningsExact identifier
application number: M012
WINCO Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWINCO FOODS, LLCf34bfb71-2c81-44d0-a2a0-4d320c43c2172026-08-07WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME ELDERBERRY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company11cac20e-9bb6-4e2d-8efd-4451f055c7b42026-08-07WarningsExact identifier
application number: M012
Winco Foods Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWINCO FOODS, LLC1d02b32a-e88d-4c70-b66d-7bdc22c25a432026-08-07WarningsExact identifier
application number: M012
foster and thrive daytime cold and flu relief nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCc1ecc56b-8052-4b0a-900a-dc93a24771bd2026-08-07WarningsExact identifier
application number: M012
Adult Long Lasting Cough ReliefDEXTROMETHORPHAN HBRShield Pharmaceuticals Corpbbf7d296-fa3d-43e5-984c-e9d2881a074d2026-08-07WarningsExact identifier
application number: M012
Severe Cold and Cough DaytimeACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEWinCo Foods, LLC790d534a-0f40-495b-a815-67851ac3d20d2026-08-07WarningsExact identifier
application number: M012
Extra Moisturizing Nasal Pump Mist Anti DripOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLC46ebd262-c6a4-43ea-a7f6-506561bb3de42026-08-07WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINWINCO FOODS, LLCe6afa830-6ce2-4abc-b5c9-3f5f156444df2026-08-07WarningsExact identifier
application number: M012
Sinus PE Pressure plus Pain MAXIMUM STRENGTHACETAMINOPHEN, PHENYLEPHRINE HCLCVS Pharmacya3b073b4-494c-4531-b08e-475c86ba321d2026-08-07WarningsExact identifier
application number: M012
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

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 SolutionPSNc91798fa-48ab-47a0-92da-4d44c2aafde05
1363752chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDc91798fa-48ab-47a0-92da-4d44c2aafde05
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSYc91798fa-48ab-47a0-92da-4d44c2aafde05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76117-001-1676117000116473 mL in 1 BOTTLE (76117-001-16) 473 ml2011-05-310000-00-00NoNoCurrent