FDA.reportPublic FDA data

SINUS AND HEADACHE

Product NDC
11822-4669
11-digit product format
118224669
Labeler code
11822
Product ID
11822-4669_98daa89f-6122-407b-a403-b88a10b5e2ab
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-09
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
Listing certified through
2027-12-31
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
SINUS AND HEADACHE
Listing expiration
2027-12-31

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
efaf3be1-ab39-45f7-a45c-7fea8705c8d0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-4669-8SINUS AND HEADACHE12 in 1 BLISTER PACKTABLET, FILM COATED123
11822-4669-8SINUS AND HEADACHE2 in 1 CARTONTABLET, FILM COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4669SINUS AND HEADACHE (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION]2Current NDC, 2 package rows20240711_efaf3be1-ab39-45f7-a45c-7fea8705c8d0.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 20 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC319e84fd-4033-f5eb-e063-6394a90aa2f32026-06-27WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLHY-VEE, INC47a6f3c3-a6fa-dd61-e063-6394a90a49652026-06-26WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLHY-VEE, INC47a717e9-56b3-e771-e063-6394a90a5c172026-06-26WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5532fd37-cdd6-97ab-e063-6394a90a3c772026-06-26WarningsExact identifier
application number: M012
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5533e705-b8d5-71cf-e063-6394a90a20102026-06-26WarningsExact identifier
application number: M012
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals265f1ce7-160c-4dda-b2e0-b78d68f962bd2026-06-26WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEBryant Ranch Prepackee052b39-1658-4071-b081-5433c87b5e4a2026-06-25WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLDOLGENCORP, LLCfae1499a-7029-4208-8436-4d330347b9152026-06-25WarningsExact identifier
application number: M012
Sinus Pressure and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLDOLGENCORP, LLC4fe8f124-ac80-40b4-8e1d-96709c459a4f2026-06-25WarningsExact identifier
application number: M012
Allergy and Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE91268cd0-c151-4744-a715-a57af3f3a3142026-06-25WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea2026-06-24WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEcb475e7f-aec1-415d-9770-07cce4e02c072026-06-24WarningsExact identifier
application number: M012
Broncolito ChildrenDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509f5b72-9894-ef44-e063-6394a90a6d072026-06-23WarningsExact identifier
application number: M012
Neo-Synephrine SeverePHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC54edaff7-d241-dc90-e063-6294a90ac64d2026-06-23WarningsExact identifier
application number: M012
AXIV Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC4b81abf9-3ea7-e996-e063-6394a90a71e82026-06-23WarningsExact identifier
application number: M012
AXIV Sinus OVERNIGHTOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC54e03a63-f978-33d4-e063-6394a90a30f22026-06-23WarningsExact identifier
application number: M012
equaline daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI9a199782-5d7e-449b-a86c-969746f0e96f2026-06-23WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Company542b9861-8055-45f6-8cbf-9fe5cde1c4d92026-06-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNefaf3be1-ab39-45f7-a45c-7fea8705c8d03
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDefaf3be1-ab39-45f7-a45c-7fea8705c8d03
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYefaf3be1-ab39-45f7-a45c-7fea8705c8d03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11822-4669-8118224669082 BLISTER PACK in 1 CARTON (11822-4669-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2024-07-09NoNoCurrent