FDA.reportPublic FDA data

Dover Sudanyl PE

Product NDC
47682-162
11-digit product format
476820162
Labeler code
47682
Product ID
47682-162_3e4c212c-9fa3-9a39-e063-6294a90a7f2e
Type
HUMAN OTC DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-12-30
Marketing end
2027-08-31
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
5 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
Dover Sudanyl PE

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
d7d62ac1-1333-4366-884b-26537766ce38Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-162-13Dover Sudanyl PE500 in 1 BOXTABLET, FILM COATED50013
47682-162-99Dover Sudanyl PE2 in 1 PACKETTABLET, FILM COATED213

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJMEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVMEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-162MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]12Current NDC, Legacy NDC, 2 package rows20241226_d7d62ac1-1333-4366-884b-26537766ce38.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 45 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuaifenesinGUAIFENESINBryant Ranch Prepack1e9887f6-209f-4f1f-9afa-a5ca649721cb2026-03-18WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamora Inc.5a7bf4cd-1d44-424d-9ef4-d484e626e3262026-03-18WarningsExact identifier
application number: M012
Harris Teeter Menthol Cough DropsMENTHOLHarris Teeter4d502c1f-7307-ac50-e063-6294a90a6ff42026-03-18WarningsExact identifier
application number: M012
Harris Teeter Cherry Cough DropsMENTHOLHarris Teeter4d50cc62-c84f-0761-e063-6394a90af54a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter Honey Lemon Cough DropsMENTHOLHarris Teeter4d516fce-d219-eee9-e063-6294a90ac59a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter SF Honey Lemon Cough DropsMENTHOLHarris Teeter4d524b45-260e-7411-e063-6294a90af6392026-03-18WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack9a77465c-6d3a-4399-9734-ad22e4b435db2026-03-18WarningsExact identifier
application number: M012
good sense childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPreferred Pharmaceuticals Inc.a56d2fe4-5bea-4668-8e66-5a6f4279d4612026-03-18WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINCardinal Health 110, LLC. DBA Leader4136e5f4-cc00-46d6-aa7f-ef56d087d7ec2026-03-18WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepackf9a0fb35-46d6-434f-8f9a-425a4bf50e842026-03-18WarningsExact identifier
application number: M012
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEGrocery Outlet7398a372-7679-423b-a3ca-8da905a979dd2026-03-17WarningsExact identifier
application number: M012
Allergy ReliefALLERGY RELIEFGrocery Outlet0661ddeb-6289-471e-af89-7f4b7452c3552026-03-16WarningsExact identifier
application number: M012
Daytime Cold and Cough Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS2cf361eb-6055-2364-e063-6294a90a69a12026-03-16WarningsExact identifier
application number: M012
Severe Cold and Flu Relief Daytime/NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYb024ab38-e5da-4f5a-888f-e2a2815782902026-03-16WarningsExact identifier
application number: M012
good neighbor pharmacy night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergen41f87d59-3245-46dc-88a8-b947675a90fc2026-03-16WarningsExact identifier
application number: M012
Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCLCVS2bc3eae8-ffe6-bc96-e063-6394a90a22832026-03-16WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP23e2d2dc-12d4-294d-e063-6394a90a95232026-03-16WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS Pharmacy48438525-e49f-9303-e063-6394a90a44f22026-03-16WarningsExact identifier
application number: M012
DaytimeACETAMINOPHEN, GUAIFENESINCVS HEALTH CORP4985c332-6602-fd2d-e063-6394a90accd22026-03-16WarningsExact identifier
application number: M012
Daytime Cold and Flu and Nighttime SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy4981bbcd-7178-335f-e063-6394a90ae9612026-03-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299145phenylephrine HCl 5 MG Oral TabletPSNd7d62ac1-1333-4366-884b-26537766ce3813
1299145phenylephrine hydrochloride 5 MG Oral TabletSCDd7d62ac1-1333-4366-884b-26537766ce3813
1299145phenylephrine HCl 5 MG Oral TabletSYd7d62ac1-1333-4366-884b-26537766ce3813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-162-1347682016213500 PACKET in 1 BOX (47682-162-13) / 2 TABLET, FILM COATED in 1 PACKET (47682-162-99) 500 packet2008-12-302027-08-31NoNoCurrent
47682-162-99476820162992 TABLET, FILM COATED in 1 PACKET (47682-162-99) 2008-12-302027-08-31NoNoCurrent