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 55 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
S2RACEPINEPHRINE HYDROCHLORIDENephron Pharmaceuticals Corporationdd1b35c7-b23b-4b95-8162-df3d263fe32e2026-01-26WarningsExact identifier
application number: M012
SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d97c634-0975-42d5-8ade-2ed2018cfe9d2026-01-26WarningsExact identifier
application number: M012
GOOD SENSE NIGHT TIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEL. Perrigo Companycd68289b-3850-40c6-9439-aae0e2d7637d2026-01-26WarningsExact identifier
application number: M012
Seacall Nasal Spray.NASAL SPRAYGuangdong Quadrant Ecological Technology Co., Ltd.1f12618b-7461-fb47-e063-6294a90af7532026-01-23WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecf7d210-102c-4053-81f6-67116de6cf7b2026-01-23WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergen44f9255b-0bf9-4573-ac9c-410acb515bc22026-01-23WarningsExact identifier
application number: M012
Daytime cold and flu non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMeijer Distribution Inc29caa3a7-7fe6-4134-a9b0-49bdb9280ca72026-01-23WarningsExact identifier
application number: M012
good neighbor pharmacy night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergene2b5c27e-ca5f-4503-a3ce-c86e1d8070a72026-01-23WarningsExact identifier
application number: M012
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
application number: M012
DRX CHOICE NIGHTTIME COLD and FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATERaritan Pharmaceuticals Inc.f466fc0e-3384-4884-832e-99bf1fdcf8992026-01-21WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR GUAIFENESINStrategic Sourcing Services LLC84750bfb-9e94-40a3-b731-21799f5e4fd12026-01-20WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRAmerisource Bergen0b58990f-2246-408e-9365-51f56bb6766c2026-01-20WarningsExact identifier
application number: M012
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATECARDINAL HEALTH 110, LLC. DBA LEADER 70000a8460fc9-2d08-4e5f-8dd3-5135ecda59232026-01-20WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINFamily Dollar Services Inc0a651316-623e-41eb-ab3a-641f5d8074252026-01-20WarningsExact identifier
application number: M012
Walgreens Maximum Strength Non Drowsy Day and Night Cold and FluWALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLUWalgreens579c47c8-6366-4785-9680-d3986ce9641d2026-01-19WarningsExact identifier
application number: M012
Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and ColdWALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLDWalgreensdd61c9d3-0b70-450e-9525-282710b383cc2026-01-19WarningsExact identifier
application number: M012
Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC48bf7422-38ef-d4b4-e063-6294a90aa3ab2026-01-19WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensfc670515-a820-4ea7-8786-8ae710798b312026-01-19WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWALGREENS9dece7b1-00b1-2499-e053-2a95a90a0be32026-01-19WarningsExact identifier
application number: M012
SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalgreens2dba2bec-e0e3-4910-89c5-ebc093e05bec2026-01-19WarningsExact 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