FDA.reportPublic FDA data

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl

Product NDC
69729-222
11-digit product format
697290222
Labeler code
69729
Product ID
69729-222_b3c20bae-91cc-dc02-e053-2995a90aaad8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
OPMX LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-08-26
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Active strength
10 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-222-062025-01-30C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-272025-01-30C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-372025-01-30C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-382025-01-30C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-272023-09-04C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-372023-09-04C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-382023-09-04C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-272022-01-28C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-372022-01-28C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-382022-01-28C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-222-06Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl2 in 1 POUCHTABLET23
69729-222-06Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl3 in 1 CARTONTABLET33
69729-222-27Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl2 in 1 POUCHTABLET23
69729-222-37Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl12 in 1 POUCHTABLET123
69729-222-38Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl144 in 1 POUCHTABLET1443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-222ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL TABLET [OPMX LLC]3Legacy NDC, 5 package rows20230905_b3c2158c-6ee1-dba9-e053-2995a90a8555.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2463332acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral TabletPSNb3c2158c-6ee1-dba9-e053-2995a90a85553
2463332acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDb3c2158c-6ee1-dba9-e053-2995a90a85553
2463332APAP 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSYb3c2158c-6ee1-dba9-e053-2995a90a85553

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69729-222-06697290222062 in 1 POUCHHistorical
69729-222-27697290222272 TABLET in 1 POUCH (69729-222-27) 2 tablet2019-08-260000-00-00NoNoCurrent
69729-222-376972902223712 TABLET in 1 POUCH (69729-222-37) 12 tablet2019-08-260000-00-00NoNoCurrent
69729-222-3869729022238144 TABLET in 1 POUCH (69729-222-38) 144 tablet2019-08-260000-00-00NoNoCurrent