FDA.reportPublic FDA data

PENTREXCILINA

Product NDC
69517-155
11-digit product format
695170155
Labeler code
69517
Product ID
69517-155_083396b6-6a36-ffc7-e063-6294a90ad8e2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
Healthlife of USA
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-05
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 5; 15 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69517-155-72e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69517-155-06e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69517-155-729bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69517-155-069bebd1f3094a…5416666fcb17…

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
04JA59TNSJInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1367205Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae9ada14-0ec8-4c01-a874-237f2108936aAvailable 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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69517-155-062023-02-23PENTREXCILINA
69517-155-722023-02-23PENTREXCILINA
69517-155-062023-01-30PENTREXCILINA
69517-155-722023-01-30PENTREXCILINA
69517-155-062021-12-03PENTREXCILINA
69517-155-722021-12-03PENTREXCILINA
69517-155-062020-01-31PENTREXCILINA
69517-155-722020-01-31PENTREXCILINA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69517-155-06PENTREXCILINA2 in 1 POUCHTABLET28
69517-155-06PENTREXCILINA6 in 1 PACKAGETABLET68
69517-155-72PENTREXCILINA2 in 1 POUCHTABLET28
69517-155-72PENTREXCILINA72 in 1 PACKAGETABLET728

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69517-155PENTREXCILINA (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) TABLET [HEALTHLIFE OF USA]8Current NDC, Legacy NDC, 4 package rows20231021_ae9ada14-0ec8-4c01-a874-237f2108936a.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 127 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Harris Teeter Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter4ebe1d94-bb15-4250-a4c2-8cd45743c7dd2024-12-18WarningsExact identifier
application number: M012
Care One Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINRETAIL BUSINESS SERVICES , LLCf6657dee-9f32-45b1-8e44-1ad67a4a68bd2024-12-18WarningsExact identifier
application number: M012
Childrens Metapp DaytimeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLGuardian Drug Company40565500-944b-47f2-8563-5df05469e4182024-12-18WarningsExact identifier
application number: M012
CVS Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINCVS Pharmacy, Inc.884abed2-e355-4134-92f1-591f3a18f71d2024-12-18WarningsExact identifier
application number: M012
CVS Health Chest Congestion Relief PEGUAIFENESIN/PHENYLEPHRINECVS Pharmacy, Inc.a49020e8-739e-47ec-8141-e866479a3ab32024-12-18WarningsExact identifier
application number: M012
Family Wellness Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINFamily Dollar Services Inc8aee8108-a4e0-4956-8e37-6b3b1c5dc6832024-12-18WarningsExact identifier
application number: M012
TopCare Chest Congestion ReliefGUAIFENESINTOPCO ASSOCIATES LLCb8339617-17ce-4ad7-af38-399ecc74d8642024-12-18WarningsExact identifier
application number: M012
Kroger Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETHE KROGER CO976bfdcf-2110-486c-aa6e-cd2067334cdc2024-12-18WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINAmerisourceBergen Drug Corp79cefd46-bd19-4a1d-9cb1-e85ff0f124942024-12-18WarningsExact identifier
application number: M012
Leader Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINCardinal Health8397e1b9-e83e-4c6a-b858-1663c23658402024-12-18WarningsExact identifier
application number: M012
GNP Mucus Relief PEGUAIFENESIN/PHENYLEPHRINEAmerisourceBergen Drug Corp63932e68-b09d-4500-bc1d-cfb2c267df1c2024-12-18WarningsExact identifier
application number: M012
Meijer Chest Congestion ReliefGUAIFENESINMeijer Distribution Inc.ae02e0bd-d9e7-495f-b01f-b135b96934a02024-12-18WarningsExact identifier
application number: M012
Topcare Chest Congestion and Sinus Congestion Relief PEGUAIFENESIN/PHENYLEPHRINETOPCO ASSOCIATES LLCb6c0362f-86ca-4f08-ba53-800c6df2c0252024-12-18WarningsExact identifier
application number: M012
Sunmark Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINStrategic Sourcing Services LLC10cad9a7-1223-470c-9027-807891217d402024-12-18WarningsExact identifier
application number: M012
Kroger Mucus ReliefGUAIFENESINTHE KROGER CO2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e2024-12-18WarningsExact identifier
application number: M012
Quality Choice Mucus ReliefGUAIFENESINChain Drug Marketing Association41f88b43-3e0a-4650-b167-a72afe6177e82024-12-18WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINRugby Laboratories5da36516-9f94-49cb-9421-0c310abcd1162024-12-18WarningsExact identifier
application number: M012
Kroger Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINTHE KROGER CO430c6604-93a7-4df6-a657-ba438aa614252024-12-18WarningsExact identifier
application number: M012
Discount Drugmart Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart, Inc1ac281e1-22ea-42f8-98fe-ab3d5ff9a2082024-12-18WarningsExact identifier
application number: M012
TopCare Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC4c50233e-1dcb-427d-ba63-1538cf3700612024-12-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367205acetaminophen 325 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 5 MG Oral TabletPSNae9ada14-0ec8-4c01-a874-237f2108936a8
1367205acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDae9ada14-0ec8-4c01-a874-237f2108936a8
1367205APAP 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral TabletSYae9ada14-0ec8-4c01-a874-237f2108936a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69517-155-06695170155066 POUCH in 1 PACKAGE (69517-155-06) / 2 TABLET in 1 POUCH6 pouch2018-01-050000-00-00NoNoCurrent
69517-155-726951701557272 POUCH in 1 PACKAGE (69517-155-72) / 2 TABLET in 1 POUCH72 pouch2018-01-050000-00-00NoNoCurrent