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 66 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safetussin PM Nighttime Cough reliefDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKramer Laboratories33dd2245-9abd-4b32-ac76-0f45a54c0f332025-12-29WarningsExact identifier
application number: M012
Winco Foods Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLWinCo Foods, LLCf54eb60d-c602-1272-e053-2995a90aa95a2025-12-28WarningsExact identifier
application number: M012
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCad4d74a8-a762-4378-9016-f7c83421073e2025-12-26WarningsExact identifier
application number: M012
Sorbutuss NRSORBUTUSSDextrum Laboratories Inc.304f1d5a-218c-51ae-e054-00144ff88e882025-12-26WarningsExact identifier
application number: M012
caring mill Cough drops CHERRYMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a28aa-00e9-8b9d-e063-6394a90ace2a2025-12-26WarningsExact identifier
application number: M012
Creamy Strawberry Flavor Cough DropCREAMY STRAWBERRY FLAVOR COUGH DROP WITH MENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2749b83a-ea4f-d8ca-e063-6394a90a69b72025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f4a026-c4d2-2645-e063-6294a90aac582025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a13b5-6fcb-70ed-e063-6394a90a7fb32025-12-26WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropHONEY LEMON FLAVOR COUGH DROPXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a4802-7c02-ccce-e063-6394a90ad71d2025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2749f353-9286-15b9-e063-6394a90a76932025-12-26WarningsExact identifier
application number: M012
Leader Cough Drops Vanilla HoneyMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a93c2c-a663-e3d1-e063-6394a90ad8592025-12-26WarningsExact identifier
application number: M012
Nite-Time COLD/FLU MedicineACETAMINOPHENAptaPharma Inc.344440bc-d810-4296-93ec-e6ae6673856b2025-12-26WarningsExact identifier
application number: M012
Nite-Time COLD/FLU Medicine CherryACETAMINOPHENAptaPharma Inc.87c2b823-ed88-44f3-8f6a-df30430b40f32025-12-26WarningsExact identifier
application number: M012
TUSSIN CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAptaPharma Inc.c005c6cf-7891-463e-b65d-1129ad4bf6ec2025-12-26WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEAptaPharma Inc.b2cef61f-ab54-4a20-a7f7-6d3da4754e8b2025-12-26WarningsExact identifier
application number: M012
CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVORDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAptaPharma Inc.9ae6fe74-80cd-482a-b3b9-3acafd6708ec2025-12-26WarningsExact identifier
application number: M012
Tussin ExpectorantGUAIFENESINAptaPharma, Inc.ca8fa216-09c1-42b2-a95b-fa3d0f13363c2025-12-26WarningsExact identifier
application number: M012
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCa9875dc9-6a27-413c-a2c7-68a86483ffc12025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC3b7e0ee7-4dda-4bbe-842c-6cbbc208acd52025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f2025-12-26WarningsExact 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