Otis Clapp Mygrex

Product NDC
47682-509
11-digit product format
476820509
Labeler code
47682
Product ID
47682-509_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
Otis Clapp Mygrex
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
47682-509-03Otis Clapp Mygrex150 in 1 BOXTABLET15021
47682-509-99Otis Clapp Mygrex2 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
47682-509MEDI 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, 2 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 119 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafewayf1d0edd5-fe58-4de0-98f4-07fb24bd0ac22025-02-19WarningsExact identifier
application number: M012
Coricidin HBP Cold and FluACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEBayer HealthCare LLC.763a5334-a741-4678-9947-6037766224502025-02-18WarningsExact identifier
application number: M012
Sof Skin Vaporizing Chest Rub and Cough SuppressantMENTHOL AND CAMPHOR AND EUCALYPTUS OILViny Health and Beauty Inc46ae16a4-b8a7-44de-ae1a-9bb503c15ea02025-02-18WarningsExact identifier
application number: M012
Pain Reliever PMACETAMINOPHEN DIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)4897d1df-4fb3-46e2-bbf0-847e964dca0a2025-02-18WarningsExact identifier
application number: M012
meijer EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bee7e4f-1813-1bdf-e063-6294a90a6a322025-02-17WarningsExact identifier
application number: M012
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCLACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCLKroger Companya24f09d9-60f1-853a-e053-2a95a90ae1fa2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFAMILY DOLLAR SERVICESa7343bea-53cc-4621-e053-2a95a90a2a5f2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCLFAMILY DOLLARaa8f6dd0-d19f-0c10-e053-2a95a90a1e8a2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGHT DAY COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCLFAMILY DOLLARaa8ebccf-6813-2dca-e053-2a95a90a032b2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENTH NIGHT COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFAMILY DOLLARaa8f0465-1595-0b0f-e053-2a95a90a00812025-02-15WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINKROGER COMPANY9bb7aaf0-6698-9a5c-e053-2a95a90a097c2025-02-14WarningsExact identifier
application number: M012
DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH-E-Bdb432947-fe02-79b2-e053-2a95a90af4a92025-02-14WarningsExact identifier
application number: M012
Halls Sugar Free CherryMENTHOLMondelez Global LLCea8dfe96-f6a4-4172-bf9e-ae3cf606ff502025-02-14WarningsExact identifier
application number: M012
Halls Sugar Free WatermelonMENTHOLMondelez Global LLCc4c090ca-f083-74e0-e053-2a95a90a9d602025-02-14WarningsExact identifier
application number: M012
Tukol Max ActionOXYMETAZOLINE HYDROCHLORIDEGenomma Lab USA73358103-43dc-4b11-9c89-9a6ba45bf1af2025-02-14WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association Inc.6c4e867b-24b9-4525-9fab-10f1e7910b132025-02-13WarningsExact identifier
application number: M012
DAYTIME- NIGHTTIME COLD AND FLUDAYTIME NIGHTTIME COLD AND FLUTARGET CORP9def204a-ee1e-6868-e053-2995a90a76b82025-02-13WarningsExact identifier
application number: M012
Daytime Cold and Flu and Nigttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.f2c11b63-278f-64de-e053-2995a90a5aae2025-02-12WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLBETTER LIVING BRANDS LLC.f29c604a-271d-a702-e053-2a95a90a34272025-02-12WarningsExact identifier
application number: M012
Nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.f2c01090-645c-1efe-e053-2995a90a7df52025-02-12WarningsExact 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
47682-509-0347682050903150 PACKET in 1 BOX (47682-509-03) / 2 TABLET in 1 PACKET (47682-509-99) 150 packet2008-12-300000-00-00NoNoCurrent
47682-509-99476820509992 TABLET in 1 PACKET (47682-509-99) 2 tablet2008-12-300000-00-00NoNoCurrent