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 34 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids AllergyDIPHENHYDRAMINE HCLGenexa Inc.a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec42026-05-08WarningsExact identifier
application number: M012
day time non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Incf4fd597f-bca2-4ed4-b353-6c734f2f885c2026-05-08WarningsExact identifier
application number: M012
Daytime Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacyd8339bb0-5da3-4f34-a819-339643cf4a972026-05-08WarningsExact identifier
application number: M012
severe tussin cfACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDa26afc33-533e-4dc0-ab25-21be87356e222026-05-08WarningsExact identifier
application number: M012
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketcdd53eba-1fa2-49c1-b03d-c32f309da7fb2026-05-08WarningsExact identifier
application number: M012
Benadryl Allergy Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCbfeae100-e2d1-4607-be3b-2d9b15cd4f7f2026-05-07WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLH E B6503761f-37ae-4f39-b727-cb75d4c4a3c92026-05-07Warnings, Adverse reactionsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLCad199488-a4be-4b6e-b806-67ce8a6e907e2026-05-07WarningsExact identifier
application number: M012
good sense nasalOXYMETAZOLINE HCLL. Perrigo Company5d42adb9-3625-4072-a6b1-29a229f255c82026-05-07WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company4856cd7b-ccdf-4546-9c65-236ebaac3dca2026-05-06WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac2026-05-06WarningsExact identifier
application number: M012
daytime cough and chest congestion dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED175cc2d0-0202-4e38-8af2-9fc126b7412d2026-05-06WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals90fae0fa-da07-4ea8-bdbd-39c2ed99ae592026-05-06WarningsExact identifier
application number: M012
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals5d8b980f-0011-41e3-a881-ad10fe3990792026-05-06WarningsExact identifier
application number: M012
HALLS MentholyptusMENTHOLMondelez Global LLC38d12374-e2c7-444c-e063-6294a90a42b32026-05-06WarningsExact identifier
application number: M012
HALLS MentholyptusMENTHOLMondelez Global LLC1ab295ff-94b1-c938-e063-6294a90a98fd2026-05-06WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.512af63d-2f09-4baa-e063-6394a90a86bd2026-05-06WarningsExact identifier
application number: M012
Thieves Chest RubCHEST RUBYoung Living Essential Oils, LC.9b7f125e-6caa-c53e-e053-2a95a90a737e2026-05-06WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Plus Pain and HeadacheACETAMINOPHEN, GUAIFENESINShield Pharmaceuticals Corpf20c0db1-dcf3-4bfc-b3e4-930398f82dc92026-05-06WarningsExact identifier
application number: M012
NitetimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc8aa6492b-1723-4c6b-82ee-4f800301c6ad2026-05-06WarningsExact 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