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 120 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Cough Drops Honey Vanilla FlavorMENTHOL7-ELEVEN2f3c43dd-175f-722e-e063-6294a90acff92025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTIN7-ELEVEN2f3c3c65-4178-6304-e063-6294a90a51fa2025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efbffd7-bbdd-c5f5-e063-6294a90a15f02025-02-25WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Vanilla FlavorMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efc46c9-a421-1998-e063-6394a90aeb642025-02-25WarningsExact identifier
application number: M012
Redicare Cough Drops Cherry FlavoredCHERRY FLAVORED MENTHOL COUGH DROPSRedicare LLC2efeaafa-ee96-37ee-e063-6394a90a9a4b2025-02-25WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLGenexa Inc.e880b8d7-61c3-41cc-e053-2995a90aaaeb2025-02-20WarningsExact identifier
application number: M012
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC596ec923-56a0-4b6e-a69c-8d740feb75a22025-02-20WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-packACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC77a2dc96-73ee-4ca2-b1fe-4069958026062025-02-19WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafewayf1d0edd5-fe58-4de0-98f4-07fb24bd0ac22025-02-19WarningsExact identifier
application number: M012
Coricidin HBP Cold and FluACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEBayer HealthCare LLC.763a5334-a741-4678-9947-6037766224502025-02-18WarningsExact identifier
application number: M012
Sof Skin Vaporizing Chest Rub and Cough SuppressantMENTHOL AND CAMPHOR AND EUCALYPTUS OILViny Health and Beauty Inc46ae16a4-b8a7-44de-ae1a-9bb503c15ea02025-02-18WarningsExact identifier
application number: M012
Pain Reliever PMACETAMINOPHEN DIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)4897d1df-4fb3-46e2-bbf0-847e964dca0a2025-02-18WarningsExact identifier
application number: M012
meijer EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bee7e4f-1813-1bdf-e063-6294a90a6a322025-02-17WarningsExact identifier
application number: M012
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCLACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCLKroger Companya24f09d9-60f1-853a-e053-2a95a90ae1fa2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFAMILY DOLLAR SERVICESa7343bea-53cc-4621-e053-2a95a90a2a5f2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCLFAMILY DOLLARaa8f6dd0-d19f-0c10-e053-2a95a90a1e8a2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGHT DAY COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCLFAMILY DOLLARaa8ebccf-6813-2dca-e053-2a95a90a032b2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENTH NIGHT COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFAMILY DOLLARaa8f0465-1595-0b0f-e053-2a95a90a00812025-02-15WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINKROGER COMPANY9bb7aaf0-6698-9a5c-e053-2a95a90a097c2025-02-14WarningsExact identifier
application number: M012
DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH-E-Bdb432947-fe02-79b2-e053-2a95a90af4a92025-02-14WarningsExact 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