FDA.reportPublic FDA data

Pentrexcilina Daytime

Product NDC
69729-223
11-digit product format
697290223
Labeler code
69729
Product ID
69729-223_56ab1a6f-9733-820a-e063-6294a90aaa97
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
OPMX LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-30
Substance
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN
Active strength
10; 4; 500 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Pentrexcilina Daytime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1
CHLORPHENIRAMINE MALEATE4 mg/1
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
V1Q0O9OJ9ZInternal 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
2463332Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b7b3c15a-bb28-5c25-e053-2a95a90ad3b1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-223-02Pentrexcilina Daytime2 in 1 POUCHTABLET25
69729-223-06Pentrexcilina Daytime2 in 1 POUCHTABLET25
69729-223-06Pentrexcilina Daytime3 in 1 CARTONTABLET35
69729-223-37Pentrexcilina Daytime2 in 1 POUCHTABLET25
69729-223-37Pentrexcilina Daytime6 in 1 CARTONTABLET65
69729-223-38Pentrexcilina Daytime2 in 1 POUCHTABLET25
69729-223-38Pentrexcilina Daytime72 in 1 CARTONTABLET725

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-223PENTREXCILINA DAYTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [OPMX LLC]5Current NDC, Legacy NDC, 7 package rows20240202_b7b3c15a-bb28-5c25-e053-2a95a90ad3b1.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 10 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIPROLIDINE HYDROCHLORIDETRIPROLIDINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC4eeffb6d-fc5e-48bc-95f6-ec4d5cb6e0d22026-08-10WarningsExact identifier
application number: M012
TRIPROLIDINE HYDROCHLORIDETRIPROLIDINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa9f01760-e335-4410-a9b8-8edce28412702026-08-10WarningsExact identifier
application number: M012
GuaifedGUAIFENESINAldama Pharmaceuticals, Inc38f37272-2084-a33b-e063-6294a90ac1502026-08-10WarningsExact identifier
application number: M012
Chlorpheniramine MaleateCHLORPHENIRAMINE MALEATEPD-Rx Pharmaceuticals, Inc.7a3452a2-930f-48b1-8c59-dbceb10b9c782026-08-10WarningsExact identifier
application number: M012
Guaifed DMDEXTROMETHORPHAN, GUAIFENESINAldama Pharmaceuticals, Inc396bf716-0f61-9563-e063-6394a90a171b2026-08-10WarningsExact identifier
application number: M012
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpeff114fe-fb15-48dd-b673-4d4d66406e692026-08-10WarningsExact identifier
application number: M012
Sleep AidDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)651b03a3-b85e-4028-a9f2-472bec16c8f42026-08-10WarningsExact identifier
application number: M012
NASALPHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC02a89765-2a75-470a-9fd6-8cce71dc19e92026-08-10WarningsExact identifier
application number: M012
WINCO Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWINCO FOODS, LLCf34bfb71-2c81-44d0-a2a0-4d320c43c2172026-08-07WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME ELDERBERRY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company11cac20e-9bb6-4e2d-8efd-4451f055c7b42026-08-07WarningsExact identifier
application number: M012
Winco Foods Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWINCO FOODS, LLC1d02b32a-e88d-4c70-b66d-7bdc22c25a432026-08-07WarningsExact identifier
application number: M012
foster and thrive daytime cold and flu relief nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCc1ecc56b-8052-4b0a-900a-dc93a24771bd2026-08-07WarningsExact identifier
application number: M012
Adult Long Lasting Cough ReliefDEXTROMETHORPHAN HBRShield Pharmaceuticals Corpbbf7d296-fa3d-43e5-984c-e9d2881a074d2026-08-07WarningsExact identifier
application number: M012
Severe Cold and Cough DaytimeACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEWinCo Foods, LLC790d534a-0f40-495b-a815-67851ac3d20d2026-08-07WarningsExact identifier
application number: M012
Extra Moisturizing Nasal Pump Mist Anti DripOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLC46ebd262-c6a4-43ea-a7f6-506561bb3de42026-08-07WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINWINCO FOODS, LLCe6afa830-6ce2-4abc-b5c9-3f5f156444df2026-08-07WarningsExact identifier
application number: M012
Sinus PE Pressure plus Pain MAXIMUM STRENGTHACETAMINOPHEN, PHENYLEPHRINE HCLCVS Pharmacya3b073b4-494c-4531-b08e-475c86ba321d2026-08-07WarningsExact identifier
application number: M012
Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEWinCo Foods, LLCdc56197c-c108-4b35-b791-dde5c3384ddd2026-08-07WarningsExact identifier
application number: M012
Sinus Severe Non Drowsy, DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.84c30ec9-a7b5-4d2f-95b2-d6fb895945de2026-08-07WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC887cabe5-46d0-4f4e-8f5a-2cfdbc157b582026-08-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2463332acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral TabletPSNb7b3c15a-bb28-5c25-e053-2a95a90ad3b15
2463332acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDb7b3c15a-bb28-5c25-e053-2a95a90ad3b15
2463332APAP 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSYb7b3c15a-bb28-5c25-e053-2a95a90ad3b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69729-223-02697290223022 TABLET in 1 POUCH (69729-223-02) 2 tablet2020-12-30NoNoCurrent
69729-223-06697290223063 POUCH in 1 CARTON (69729-223-06) / 2 TABLET in 1 POUCH3 pouch2024-01-10NoNoCurrent
69729-223-37697290223376 POUCH in 1 CARTON (69729-223-37) / 2 TABLET in 1 POUCH6 pouch2024-01-10NoNoCurrent
69729-223-386972902233872 POUCH in 1 CARTON (69729-223-38) / 2 TABLET in 1 POUCH72 pouch2020-12-300000-00-00NoNoCurrent
69729-223-506972902235050 POUCH in 1 CARTON (69729-223-50) / 2 TABLET in 1 POUCH50 pouch2020-12-30NoNoCurrent