FDA.reportPublic FDA data

Sinus plus Headache

Product NDC
72036-323
11-digit product format
720360323
Labeler code
72036
Product ID
72036-323_25136855-e660-eba6-e063-6394a90a08c7
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Harris Teeter
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-19
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
2026-12-31
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 plus Headache
Listing expiration
2026-12-31

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
c9d82968-b2ec-2f4b-e053-2a95a90a7f0cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72036-323-05Sinus plus Headache2 in 1 CARTONTABLET, COATED23
72036-323-05Sinus plus Headache12 in 1 BLISTER PACKTABLET, COATED123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72036-323SINUS PLUS HEADACHE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HARRIS TEETER]3Current NDC, Legacy NDC, 2 package rows20241024_c9d82968-b2ec-2f4b-e053-2a95a90a7f0c.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 TabletPSNc9d82968-b2ec-2f4b-e053-2a95a90a7f0c3
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDc9d82968-b2ec-2f4b-e053-2a95a90a7f0c3
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYc9d82968-b2ec-2f4b-e053-2a95a90a7f0c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72036-323-05720360323052 BLISTER PACK in 1 CARTON (72036-323-05) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2020-06-190000-00-00NoNoCurrent