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 135 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c62024-11-21WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.028b025e-2dde-4bef-ba7b-61774e855b4b2024-11-21WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC856cb3c3-8f32-4285-8c13-25f01779a31a2024-11-21WarningsExact identifier
application number: M012
Night Time Severe Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC3375a059-2939-438e-92b5-a7f1952bbb222024-11-21WarningsExact identifier
application number: M012
NiteTime Cold/Flu, Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc9033bf94-f444-4488-b717-050d04dee3882024-11-21WarningsExact identifier
application number: M012
Day and Night Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.4b554ce8-9a6a-444f-b5ea-63359bbc06532024-11-21WarningsExact identifier
application number: M012
Day Severe Cold and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.7492b381-9eca-4b07-b356-63fdaea14f812024-11-21WarningsExact identifier
application number: M012
Severe sinus Congestion ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLCe173bec9-14df-4535-a023-47d8cda8d4ec2024-11-21WarningsExact identifier
application number: M012
COLD FLU and SORE THROAT RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLC1161e5dc-0677-4fb9-964f-971a508098b62024-11-21WarningsExact identifier
application number: M012
Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERetail Business Services, LLCfc8c70d6-6be5-4f12-84b0-125fc82149ec2024-11-21WarningsExact identifier
application number: M012
12 Hour Original Nasal DecongestantNASAL SPRAYWinCo Foods LLCb3b6065a-56da-45e9-b89d-f6553bc181c92024-11-21WarningsExact identifier
application number: M012
Family Wellness Oxymetazoline Sinus SevereOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)13237d31-c60a-49f8-9b96-4414cf766a082024-11-21WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5b55d1df-275b-40d8-bde3-fc43313b7eb32024-11-20WarningsExact identifier
application number: M012
Halls Green AppleMENTHOLMondelez Global LLC1bb8dcb2-c3a8-a64e-e063-6294a90ae4a22024-11-20WarningsExact identifier
application number: M012
Halls BlueberryMENTHOLMondelez Global LLC275a6935-ea44-486e-e063-6394a90ae19a2024-11-20WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYWalgreens Company234bd567-4e3c-419f-a000-fdfc28cafc8b2024-11-20WarningsExact identifier
application number: M012
NICE Assorted Cough DropsMENTHOLLeosons Overseas Corp96db0f37-41cc-1ebd-e053-2a95a90a32152024-11-19WarningsExact identifier
application number: M012
Nice Cherry Cough DropsMENTHOLLeosons Overseas Corp98e52604-6e41-6408-e053-2995a90a6bc82024-11-19WarningsExact identifier
application number: M012
NICE Citrus Cough DropsMENTHOLLeosons Overseas Corp96d9527d-9bf9-ce82-e053-2995a90aff0c2024-11-19WarningsExact identifier
application number: M012
NICE Menthol Cough DropsMENTHOLLeosons Overseas Corp96d77897-475c-482c-e053-2995a90a2da42024-11-19WarningsExact 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
47682-509-0347682050903150 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