FDA.reportPublic FDA data

SU PHEDRINE PE

Product NDC
57243-453
11-digit product format
572430453
Labeler code
57243
Product ID
57243-453_5ae58203-4d1e-42ed-bbbe-e27aca71dc91
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Salado Sales, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-01-14
Marketing end
2026-11-30
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
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
SU PHEDRINE PE
Brand name suffix
Non-Drowsy, Maximum Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 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
1049182Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9056fa58-d6aa-4df5-97e0-9be3f2332f86Available 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
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57243-453-44SU PHEDRINE PENon-Drowsy, Maximum Strength1 in 1 CARTONTABLET, FILM COATED115
57243-453-44SU PHEDRINE PENon-Drowsy, Maximum Strength18 in 1 BLISTER PACKTABLET, FILM COATED1815

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GSU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57243-453SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]14Current NDC, Legacy NDC, 2 package rows20250117_9056fa58-d6aa-4df5-97e0-9be3f2332f86.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 130 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINTHE KROGER CO430c6604-93a7-4df6-a657-ba438aa614252024-12-18WarningsExact identifier
application number: M012
Discount Drugmart Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart, Inc1ac281e1-22ea-42f8-98fe-ab3d5ff9a2082024-12-18WarningsExact identifier
application number: M012
TopCare Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC4c50233e-1dcb-427d-ba63-1538cf3700612024-12-18WarningsExact identifier
application number: M012
Dollar General Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINDolgencorp, LLC718f08d2-3757-4f3e-915e-3e4982ad090f2024-12-18WarningsExact identifier
application number: M012
Good Neighbor Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmerisourceBergen Drug Corpe4610d53-4459-43a0-9351-f0ac8586df602024-12-18WarningsExact identifier
application number: M012
Always Save Mucus Relief PEGUAIFENESIN/PHENYLEPHRINEValu Merch5fb7ceb4-97da-4aa5-baa4-9eb2778ee2f62024-12-17WarningsExact identifier
application number: M012
ChestrubCAMPHOR MENTHOL EUCALYPTUS OILDelta Brands Inc8e6f731f-c16a-41b2-9786-0cab588cfc8e2024-12-17WarningsExact identifier
application number: M012
Mentholatum Nighttime Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company5539ae74-9723-480d-b35f-0a6644bf54ad2024-12-17WarningsExact identifier
application number: M012
Mentholatum No Mess Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyf4675bc1-01cc-4a33-a3bf-bfc99230fe322024-12-17WarningsExact identifier
application number: M012
Mentholatum Cherry Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyde01225a-eabb-4972-bf3a-3e5a0e44abef2024-12-17WarningsExact identifier
application number: M012
Rite Aid Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLRite Aid Corporation198a666a-3f34-4e4f-89e8-ec7f412f00af2024-12-17WarningsExact identifier
application number: M012
Equate Childrens VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc372e66a6-1f1f-4aa3-a2ed-d215fafee9b92024-12-17WarningsExact identifier
application number: M012
Caring Mill Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFSA Store Inc.caa83419-c332-4b92-b151-22da2fa852892024-12-17WarningsExact identifier
application number: M012
Always Save Chest Congestion Relief GUAFGUAIFENESINValu Merch9d81d88b-2db9-4891-942b-fecb1be961dd2024-12-17WarningsExact identifier
application number: M012
Kroger EXTRA STRENGTH Acetaminophen PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.24a75ffa-c2a7-71a9-e063-6394a90a0e252024-12-17WarningsExact identifier
application number: M012
Allergy 36ct, Caseys 4goodDIPHENHYDRAMINE HCL 25MGLil' Drug Store Products, Inc.04b78b23-424d-9762-e063-6394a90a52e32024-12-16WarningsExact identifier
application number: M012
Sinus Relief, Caseys 4goodACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store Products, Inc.033837c0-fa68-a38d-e063-6394a90a98322024-12-16WarningsExact identifier
application number: M012
DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.cfab9b80-0580-4482-b6e3-0aab875b57972024-12-16WarningsExact identifier
application number: M012
Allergy Relief, 24-7 Lift by 7-ElevenDIPHENHYDRAMINE HCL 25MGLil' Drug Store products, Inc.04c9db9a-95ef-3a48-e063-6294a90a4e8e2024-12-16WarningsExact identifier
application number: M012
Cold and Flu Daytime Severe, 24/7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLETLil' Drug Store Products, Inc.05cc7185-d49d-82a3-e063-6294a90a568e2024-12-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSN9056fa58-d6aa-4df5-97e0-9be3f2332f8615
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD9056fa58-d6aa-4df5-97e0-9be3f2332f8615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57243-453-44572430453441 BLISTER PACK in 1 CARTON (57243-453-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2005-01-142026-11-30NoNoCurrent