FDA.reportPublic FDA data

Decongestant PE

Product NDC
69168-271
11-digit product format
691680271
Labeler code
69168
Product ID
69168-271_2b621db5-4138-44f0-9c86-28468ba954af
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-23
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [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
Decongestant PE
Brand name suffix
Non Drowsy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1299145Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a3098b4-381c-4f32-97a7-87b53fd64428Available 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
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
69168-271-17Decongestant PENon Drowsy300 in 1 BOTTLETABLET3006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-271DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]5Current NDC, Legacy NDC, 1 package rows20231114_7a3098b4-381c-4f32-97a7-87b53fd64428.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 40 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. dba Leadere7ad8d2d-01fd-40d9-a972-b2ca14cc97fb2026-04-09WarningsExact identifier
application number: M012
Sinus and Headache DaytimeACETAMINOPHEN, PHENYLEPHRINE HCLL.N.K. International, Inc.e20b1093-d77f-4c39-b105-adaa1b82ea762026-04-09WarningsExact identifier
application number: M012
Alka Seltzer Cold Cold and Congestion Severe Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.4f0c1b8e-3fb1-ccf2-e063-6394a90acd152026-04-09WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATELidl US LLCb26ac105-f8e4-4ad0-8a26-9fdf30c017002026-04-09WarningsExact identifier
application number: M012
Wal Dryl Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEWalgreens09de28cd-fa60-4af7-b7cc-cf74c00a35312026-04-09WarningsExact identifier
application number: M012
Tussin DM Max NIGHTTIMEDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companyd10a413e-22a6-4799-8367-5777831756a92026-04-09WarningsExact identifier
application number: M012
Sinus Pressure and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader80d25e23-b108-4eb1-88c7-73fe9da8f9422026-04-09WarningsExact identifier
application number: M012
Mucus Relief DM CoughDEXTROMETHORPHAN HBR AND GUAIFENESINL.N.K. International, Inc.2fea3533-8218-4875-affe-5b33a22c553a2026-04-08WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Plus Chest CongestionACETAMINOPHEN, GUAIFENESINKenvue Brands LLC4e60e1ad-4ad4-c329-e063-6294a90ab3182026-04-08WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC4592d547-556f-4eec-8faf-6ff9a92e46c82026-04-08WarningsExact identifier
application number: M012
Goodmeds Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.e24121d2-c9d2-4bbd-869e-eeed7e2bb8812026-04-08WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLStrategic Sourcing Services LLC8460d4f9-8d7b-4ae4-8047-c2010d9c80132026-04-08WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leaderd2dab450-cf82-4be2-a4e2-630295fb59ab2026-04-08WarningsExact identifier
application number: M012
Nighttime CoughDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreens4657c02b-887b-4746-8a78-83a72465e07b2026-04-08WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED33646fab-79a5-4f10-8ac0-48423eac9b562026-04-07WarningsExact identifier
application number: M012
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLC76e19b9a-3bdb-479a-9503-9e8250109c842026-04-07WarningsExact identifier
application number: M012
equate daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.7959ea00-2a41-4c3c-8c58-85795ebd2afc2026-04-06WarningsExact identifier
application number: M012
dimaphen dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPreferred Pharmaceuticals Inc.da148c1d-e394-4367-83e0-533469501b302026-04-06WarningsExact identifier
application number: M012
Cough Relief AdultDEXTROMETHORPHAN HBRTOP CARE (Topco Associates LLC)b2ebfeb3-e248-40bf-81d3-81c5fb532dbe2026-04-06WarningsExact identifier
application number: M012
Allergy Plus Sinus ReliefDIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLRite Aid Corporation54623e2e-5f9a-426e-8f7e-ea755ff8b3f82026-04-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299145phenylephrine HCl 5 MG Oral TabletPSN7a3098b4-381c-4f32-97a7-87b53fd644286
1299145phenylephrine hydrochloride 5 MG Oral TabletSCD7a3098b4-381c-4f32-97a7-87b53fd644286
1299145phenylephrine HCl 5 MG Oral TabletSY7a3098b4-381c-4f32-97a7-87b53fd644286

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-271-1769168027117300 TABLET in 1 BOTTLE (69168-271-17) 300 tablet2021-06-160000-00-00NoNoCurrent