FDA.reportPublic FDA data

Medi First Plus Sinus Pain and Pressure

Product NDC
47682-919
11-digit product format
476820919
Labeler code
47682
Product ID
47682-919_3e4c1ebf-19a0-ecd3-e063-6394a90a6575
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-12-30
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
500; 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
Medi First Plus Sinus Pain and Pressure
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 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
04JA59TNSJInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1101534Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f196f2c5-a100-42b1-bd01-0327b223838eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-919-33Medi First Plus Sinus Pain and Pressure50 in 1 BOXTABLET5021
47682-919-33Medi First Plus Sinus Pain and Pressure2 in 1 PACKETTABLET221
47682-919-48Medi First Plus Sinus Pain and Pressure125 in 1 BOXTABLET12521
47682-919-48Medi First Plus Sinus Pain and Pressure2 in 1 PACKETTABLET221

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJMEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVMEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]4
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EMEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-919MEDI FIRST SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET MEDI FIRST PLUS SINUS PAIN AND PRESSURE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET OTIS CLAPP MYGREX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]20Current NDC, Legacy NDC, 4 package rows20241115_f196f2c5-a100-42b1-bd01-0327b223838e.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 111 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pentrexcilina Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e5c17-28f2-7186-e053-2995a90a51f62025-07-17WarningsExact identifier
application number: M012
Viro Flu PM ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe1553da8-3a89-e258-e053-2a95a90a47252025-07-17WarningsExact identifier
application number: M012
ACTICON PEDIATRICDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC3052cc67-e6c0-4d3f-9ec9-ffe58d9fae232025-07-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDemoulas Super Markets, Inc397f5acd-31c0-683e-e063-6394a90a7e542025-07-16WarningsExact identifier
application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC19ad2cca-c1cb-019c-e063-6294a90a56442025-07-16WarningsExact identifier
application number: M012
DG HEALTH COLD FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDolgencorp Inc8ea03891-2fbc-4413-8e6d-de903d426f8d2025-07-16WarningsExact identifier
application number: M012
up and up nighttime flu and severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationdf488727-b913-440b-9a0b-cce3ae143bf22025-07-15WarningsExact identifier
application number: M012
Topcare DayTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLCbb9663e3-fd11-4e72-bf85-fee4841b795f2025-07-15WarningsExact identifier
application number: M012
DG HEALTH COLD FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Inc320e4f32-66aa-48be-9afd-fa2b2c217dc12025-07-14WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.f29da4ca-443d-7035-e053-2a95a90acab82025-07-14WarningsExact identifier
application number: M012
CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS PHARMACYcdc9af7c-3766-4573-9d95-bf217907b9322025-07-11WarningsExact identifier
application number: M012
Health Smart Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUS OILInternational Wholesale Inc398fee3d-7d93-9dbc-e063-6294a90abdcc2025-07-10WarningsExact identifier
application number: M012
HEADACHE RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINEKroger Companybbed29a1-3c52-3531-e053-2995a90a686c2025-07-10WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INCb765c82e-5021-4772-8647-c5ebc596bc0a2025-07-10WarningsExact identifier
application number: M012
Sinus Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyc378acaf-389a-4afb-a4f0-e367a907a4682025-07-10WarningsExact identifier
application number: M012
Nasal Decongestant Non-DrowsyPSEUDOEPHEDRINE HCLCVS Pharmacy3330b077-dab7-45c6-acbb-0f91f22712322025-07-09WarningsExact identifier
application number: M012
ACTIDOGESIC DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEACTIPHARMA, LLCff8e2565-bce3-4c06-a416-6e8f369f057f2025-07-09WarningsExact identifier
application number: M012
ACTINELDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLCdb0cb6ae-0a4d-4232-805a-f3f3a058261f2025-07-08WarningsExact identifier
application number: M012
HALLS Extra StrongMENTHOLMondelez Global LLC396f93a9-8d2c-2f27-e063-6294a90ab3442025-07-08WarningsExact identifier
application number: M012
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLCaea0335d-75e6-4a90-86a5-f197cf024a112025-07-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101534acetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSNf196f2c5-a100-42b1-bd01-0327b223838e21
1101534acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf196f2c5-a100-42b1-bd01-0327b223838e21
1101534APAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYf196f2c5-a100-42b1-bd01-0327b223838e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-919-334768209193350 PACKET in 1 BOX (47682-919-33) / 2 TABLET in 1 PACKET50 packet2008-12-300000-00-00NoNoCurrent
47682-919-4847682091948125 PACKET in 1 BOX (47682-919-48) / 2 TABLET in 1 PACKET125 packet2008-12-300000-00-00NoNoCurrent