FDA.reportPublic FDA data

Sinus PE Congestion

Product NDC
0363-4534
11-digit product format
003634534
Labeler code
0363
Product ID
0363-4534_04dde71c-38ba-4412-b583-097958bf2d19
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl, Phenylephrine HCl
Dosage form
KIT
Labeler
Walgreen Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-19
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
Sinus PE Congestion
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049182Internal RxNorm lookup
1052928Internal RxNorm lookup
2639176Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b9151b7-3e40-4f37-b3e0-4c0fa0115b71Available 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
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4534-09Sinus PE Congestion1 in 1 PACKAGE, COMBINATIONKIT19
0363-7453-42Sinus PE Congestion12 in 1 BLISTER PACKTABLET, FILM COATED1210 mg9
0363-7485-40Sinus PE Congestion8 in 1 BLISTER PACKTABLET, FILM COATED825 mg9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4534SINUS PE CONGESTION (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREEN COMPANY]8Current NDC, Legacy NDC, 3 package rows20250130_5b9151b7-3e40-4f37-b3e0-4c0fa0115b71.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 36 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Panadol Cold and Flu NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3417993d-8e3c-23d6-e063-6394a90a7d502026-04-29WarningsExact identifier
application number: M012
Halls Sugar Free Mountain MentholMENTHOLMondelez Global LLC509f233e-ff01-8927-e063-6394a90a99292026-04-29WarningsExact identifier
application number: M012
Broncomiel AdultsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509c61d3-ae16-be5c-e063-6294a90a68da2026-04-29WarningsExact identifier
application number: M012
Mucus Relief DM Max Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINTOP CARE (Topco Associates LLC)aa1eb90c-e565-455f-8978-6f2f9e00a8142026-04-29WarningsExact identifier
application number: M012
Tussin Cough and Chest Congestion DM adultDEXTROMETHORPHAN HBR, GUAIFENESINHarris Teeter, LLCe1280355-da81-489f-9bd2-ffea9a68010c2026-04-29WarningsExact identifier
application number: M012
Mucus Relief ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC7b095ec5-9951-4491-9b68-7ac0a7f100532026-04-29WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOP CARE (Topco Associates LLC)98dd0ba6-0109-46b2-92df-11a0309842402026-04-28WarningsExact identifier
application number: M012
Pain, Headache and CongestionACETAMINOPHEN, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED41a77cbb-6a4d-46a4-ab27-c7affa2cc6822026-04-28WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.dd7da15a-4e0b-405f-e053-2995a90a06d22026-04-28WarningsExact identifier
application number: M012
CAREONE CHILDRENS COLD COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDERetail Business Services, LLC382f7d51-ceb8-4bdf-9bd5-440b50c65cd32026-04-28WarningsExact identifier
application number: M012
Cold and Flu Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.1a520b4f-6a4b-4e37-94c5-9387f2e4c34a2026-04-27WarningsExact identifier
application number: M012
Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKroger49a7cd2a-8c0e-2196-e063-6294a90a134a2026-04-27WarningsExact identifier
application number: M012
Guaifenesin,Dextromethorphan HbrGUAIFENESIN,DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd3e5d978f-cc70-60a5-e063-6394a90a67d32026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd36ced59c-12dc-441f-e063-6294a90a32392026-04-27WarningsExact identifier
application number: M012
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLSoftgel Healthcare Private Limited30ab39f3-27cc-5728-e063-6394a90a9cbe2026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited353f71f7-81e0-08c2-e063-6294a90acb492026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr ,GuaifenesinACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESINSoftgel Healthcare Pvt Ltd353ef34f-760d-ae92-e063-6294a90a5b4a2026-04-27WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0203d919-dc1f-cca0-e063-6394a90aa1aa2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.507214ad-1e06-fe21-e063-6294a90a59cd2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50738a43-7299-270c-e063-6294a90af2cc2026-04-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2639176{1 (diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) / 1 (phenylephrine hydrochloride 10 MG Oral Tablet) } PackGPCK5b9151b7-3e40-4f37-b3e0-4c0fa0115b719
26391761 daytime (phenylephrine hydrochloride 10 MG Oral Tablet) / 1 nighttime (diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) PackPSN5b9151b7-3e40-4f37-b3e0-4c0fa0115b719
1052928diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral TabletPSN5b9151b7-3e40-4f37-b3e0-4c0fa0115b719
1049182phenylephrine HCl 10 MG Oral TabletPSN5b9151b7-3e40-4f37-b3e0-4c0fa0115b719
1052928diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD5b9151b7-3e40-4f37-b3e0-4c0fa0115b719
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD5b9151b7-3e40-4f37-b3e0-4c0fa0115b719
26391761 daytime (phenylephrine hydrochloride 10 MG Oral Tablet) / 1 nighttime (diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) PackSY5b9151b7-3e40-4f37-b3e0-4c0fa0115b719

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-4534-09003634534091 KIT in 1 PACKAGE, COMBINATION (0363-4534-09) * 12 TABLET, FILM COATED in 1 BLISTER PACK (0363-7453-42) * 8 TABLET, FILM COATED in 1 BLISTER PACK (0363-7485-40) 1 kit2022-01-190000-00-00NoNoCurrent
0363-7453-420036374534212 in 1 BLISTER PACKHistorical
0363-7485-40003637485408 in 1 BLISTER PACKHistorical