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 6 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HyVee Daytime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc496ec389-1aea-f202-e063-6394a90ae51c2026-08-20WarningsExact identifier
application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact identifier
application number: M012
CVS Adult Cough plus Chest Congestion DM Max with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY822d5bf6-8841-4b7f-bbf7-90c3d50b80242026-08-19WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC2517b241-c433-440f-999d-5a32d5bbaa262026-08-19WarningsExact identifier
application number: M012
Daytime and Nighttime Cough and Chest Congestion ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATECVS Pharmacy347f1731-5b85-4220-ae2b-9497a3afa4ed2026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACYe1c246a4-7a8c-4761-ab26-13b5165029cc2026-08-19WarningsExact identifier
application number: M012
CVS childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRCVS PHARMACY035c5e2a-04e3-490b-8f1a-233a5cb6eadb2026-08-19WarningsExact identifier
application number: M012
rugby cough syrupDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratories89752c69-25c8-45e3-9021-f81b35b52d362026-08-19WarningsExact 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