FDA.reportPublic FDA data

Sinus Headache PEMaximum Strength Non-Drowsy

Product NDC
69168-270
11-digit product format
691680270
Labeler code
69168
Product ID
69168-270_5614edd7-fae9-4261-aa48-bd393f771caa
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-22
Marketing end
2027-10-31
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 Headache PEMaximum Strength Non-Drowsy
Brand name suffix
Maximum Strength Non-Drowsy

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
b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69168-270-952020-03-13C16284748780-19d75b9d0-f02b-f424-e053-dadaa90a57ceDrug Facts
69168-270-952020-01-31C16284748780-19d75b9d0-f02b-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-270-95Sinus Headache PEMaximum Strength Non-DrowsyMaximum Strength Non-Drowsy18 in 1 BLISTER PACKTABLET187

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSINUS HEADACHE PE MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-270SINUS HEADACHE PEMAXIMUM STRENGTH NON-DROWSY MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]6Current NDC, Legacy NDC, 1 package rows20231114_b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f.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 27 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREENS CO.d92d97a8-0ee3-1206-e053-2a95a90a72a82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSAM'S WEST INC0c8e7095-0806-4501-e063-6394a90a89aa2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREEN CO.b3763182-2428-155a-e053-2995a90ab5782025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREENSe467b78e-9f23-5563-e053-2a95a90a586e2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWalgreensfd7c3250-35d4-494a-e053-6394a90a2db52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC1ddb8a2b-3081-3eda-e063-6294a90ab82b2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCb1307d52-10e6-46e1-e053-2995a90a03b62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCc2c6d6a1-b492-506d-e053-2995a90aac232025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
application number: M013
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINNUVICARE LLC3a4aa3c7-b726-4303-8803-74196fa5637a2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
application number: M013
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company07bc6632-fabb-427d-81f3-c27c54caa6a02025-12-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f7
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f7
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-270-956916802709518 TABLET in 1 BLISTER PACK (69168-270-95) 18 tablet2014-12-222027-10-31NoNoCurrent