FDA.reportPublic FDA data

Sinus and Headache

Product NDC
50844-467
11-digit product format
508440467
Labeler code
50844
Product ID
50844-467_448f6ba2-0be3-4557-a64b-36636de255f9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-07-26
Marketing end
2027-03-31
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 5 mg/1; 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
Sinus and Headache
Brand name suffix
Daytime

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal 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
1046378Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e20b1093-d77f-4c39-b105-adaa1b82ea76Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-467-02Sinus and HeadacheDaytime1 in 1 CARTONTABLET, FILM COATED111
50844-467-02Sinus and HeadacheDaytime12 in 1 BLISTER PACKTABLET, FILM COATED1211
50844-467-08Sinus and HeadacheDaytime2 in 1 CARTONTABLET, FILM COATED211
50844-467-08Sinus and HeadacheDaytime12 in 1 BLISTER PACKTABLET, FILM COATED1211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-467SINUS AND HEADACHE DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]11Current NDC, Legacy NDC, 4 package rows20250423_e20b1093-d77f-4c39-b105-adaa1b82ea76.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 57 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREEN COMPANY5bf72e2f-15c8-466a-9e13-50654233da912026-01-19WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreens9862f84d-1c18-4ef7-86dc-98572599d4172026-01-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreens37853689-c9ca-4bc7-9c5b-4a68b8d778be2026-01-19WarningsExact identifier
application number: M012
VAPORXCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLAKRON PHARMA INC51b32162-0c5a-4b5b-999a-34337d8166032026-01-19WarningsExact identifier
application number: M012
EquateOXYMETAZOLINE HCLWalmart Inc2f762c24-2442-506a-e063-6394a90a3b962026-01-19WarningsExact identifier
application number: M012
DimetaneDIPHENHYDRAMINE HYDROCHLORIDERising Pharma Holdings, Inc.484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f2026-01-19WarningsExact identifier
application number: M012
nitetimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Incf681d986-9838-42d8-8ed9-732a39fbf8702026-01-19WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLH E B22d241c5-a3fd-4619-8147-91d7a4c8cf982026-01-19WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLBetter Living Brands, LLC9fe63ca6-3863-4175-9aec-ecd6ebbdb2492026-01-19WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergen5749ce9d-e182-478f-ab88-b520a35a99a72026-01-19WarningsExact identifier
application number: M012
Foster and Thrive Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC1d9150b1-2f6c-4c33-8c93-3ed1d88585e22026-01-18WarningsExact identifier
application number: M012
HealthWise Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcarece3ceffd-3ff5-3795-e053-2995a90a827f2026-01-18WarningsExact identifier
application number: M012
topcare nite time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLC31210a95-f9dc-49db-aab5-25c4dca492662026-01-17WarningsExact identifier
application number: M012
Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf77226c0-b6d5-9fd0-e053-6294a90a4b572026-01-16WarningsExact identifier
application number: M012
Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf691734b-5cf4-6eb8-e053-2a95a90aee802026-01-16WarningsExact identifier
application number: M012
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf771aa19-295a-9f4e-e053-6294a90a16742026-01-16WarningsExact identifier
application number: M012
CVS Cherry Cough DropsMENTHOLCVS Pharmacyde5c4b94-0420-5d43-e053-2995a90aa5a52026-01-16WarningsExact identifier
application number: M012
CVS Honey Lemon Cough DropsMENTHOLCVS Pharmacyde963dc3-8108-440f-e053-2995a90a906f2026-01-16WarningsExact identifier
application number: M012
CVS SF Menthol Cough DropsMENTHOLCVS Pharmacye08f8ca3-b683-4964-e053-2a95a90afabb2026-01-16WarningsExact identifier
application number: M012
CVS SF Honey Lemon Cough DropsMENTHOLCVS Pharmacye0cdeccf-c32f-318a-e053-2a95a90ac4012026-01-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNe20b1093-d77f-4c39-b105-adaa1b82ea7611
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe20b1093-d77f-4c39-b105-adaa1b82ea7611
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYe20b1093-d77f-4c39-b105-adaa1b82ea7611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-467-02508440467021 BLISTER PACK in 1 CARTON (50844-467-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2005-07-262027-03-31NoNoCurrent
50844-467-08508440467082 BLISTER PACK in 1 CARTON (50844-467-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-07-262027-03-31NoNoCurrent