FDA.reportPublic FDA data

RYNEX PE

Product NDC
0485-0202
11-digit product format
004850202
Labeler code
0485
Product ID
0485-0202_4c481ad3-2e51-1c12-e063-6294a90a4b6b
Type
HUMAN OTC DRUG
Nonproprietary name
BROMPHENIRAMINE MALEATE and Phenylephrine HCL
Dosage form
LIQUID
Route
ORAL
Labeler
EDWARDS PHARMACEUTICALS, INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-07
Substance
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
1; 2.5 mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 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
RYNEX PE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE1 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IXA7C9ZN03Internal 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
1053258Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
77ae1cf6-b8e5-4f3c-b7bc-e2609a8991efAvailable 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
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0485-0202-16RYNEX PE473 mL in 1 BOTTLE, PLASTICLIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0485-0202-16ML - Milliliter0485-02027df84534-7fde-4615-bd19-b4d1caf0f08312013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NRYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNRYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FRYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPRYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TRYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFRYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHRYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RRYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4RYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RRYNEX PE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0485-0202RYNEX PE (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) LIQUID [EDWARDS PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20241228_77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef.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 117 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REVASOL CHILDRENS ALLERGYDIPHENHYDRAMINE HCLRnv LLC3143137f-ef42-5358-e063-6394a90a8ed12025-03-26WarningsExact identifier
application number: M012
Rompe Pecho SF FLUDEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEEfficient Laboratories Incbc10695a-9664-4ce3-82bb-820da06129fa2025-03-26WarningsExact identifier
application number: M012
SUPRESS-PE PediatricGUIAFENESIN, PHENYLEPHRINE HCLKramer Novisa474171d-5c29-4a80-9d37-00613796211a2025-03-26WarningsExact identifier
application number: M012
Guaifenesin DMDEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESINInnovida Pharmaeutique Corporationdd3f806b-2470-4055-94e1-18adac8110252025-03-25WarningsExact identifier
application number: M012
Foster and Thrive childrens cold cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC38b710e3-1d01-4ff4-a6b6-44936f277f492025-03-25WarningsExact identifier
application number: M012
Revasol Tussin DM Max with HoneyDEXTROMETHORPHAN HBR AND GUAIFENESINRnv LLC30da9255-c93a-84d6-e063-6394a90a7c2a2025-03-21WarningsExact identifier
application number: M012
REVASOL NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATERnv LLC30dfd8f7-4cc6-d4f2-e063-6394a90aa9c92025-03-21WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINMeijer, Inc.261a79b3-5704-76f2-e063-6394a90a5ac62025-03-20WarningsExact identifier
application number: M012
Rompe Tos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cc932d-b412-0710-e063-6394a90a87f62025-03-19WarningsExact identifier
application number: M012
Rompe Tos X AdultsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05abb2db-d22e-90b5-e063-6294a90ace3f2025-03-19WarningsExact identifier
application number: M012
Sinus Head CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLC30a07773-bd6f-b9f2-e063-6394a90ab8aa2025-03-18WarningsExact identifier
application number: M012
Halls Sugar Free Black CherryMENTHOLMondelez Global LLCbd2a311a-bf0c-4365-af9b-76675c243b222025-03-16WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTARGET CORPORATIONfbca9627-5e12-048a-e053-6294a90a6e0f2025-03-15WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLDOLGENCORP, INC.0655688e-7c42-507f-e063-6294a90ae4982025-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY, INC1b8d5494-1fcf-4cd0-acc0-34f17d577bd72025-03-14WarningsExact identifier
application number: M012
Ultra Concentrated Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300b2357-933b-fe9a-e063-6294a90aa4b92025-03-11WarningsExact identifier
application number: M012
Ultra Concentrated Nighttime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEPuraCap Pharmaceutical LLC300bf27f-744f-7366-e063-6394a90acbcb2025-03-11WarningsExact identifier
application number: M012
Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300c7c7b-ea0b-3650-e063-6294a90a65e82025-03-11WarningsExact identifier
application number: M012
Rompe Pecho NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEFFICIENT LABORATORIES INC2ec319a8-92bf-4552-86dd-37cbce18980f2025-03-11WarningsExact identifier
application number: M012
HISTEX-DM New FormulationDEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCIAllegis Pharmaceuticals, LLC30010401-e5b4-2bd9-e063-6394a90a0b0b2025-03-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef9
1053258brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef9
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral ElixirSY77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef9
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef9
1053258brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0485-0202-1600485020216473 mL in 1 BOTTLE, PLASTIC (0485-0202-16) 473 ml2011-03-070000-00-00NoNoCurrent