Daytime Cold and Flu

Product NDC
59726-848
Requested package NDC
59726-848-08
11-digit product format
597260848
Labeler code
59726
Product ID
59726-848_f4563c5f-3acd-46dd-87cf-2b1f558139f8
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
P & L Development, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-06-30
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59726-84859726-848-08DDiscontinued by firm2026-10-12

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 · 5 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-27Drug Facts
2022-01-28Drug Facts
2020-12-05Drug Facts
2020-09-27Drug Facts
2020-09-25Drug Facts
2020-07-22Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-848DAYTIME COLD AND FLU NON DROWSY (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [P & L DEVELOPMENT, LLC]4Legacy NDC20240501_ab077ce2-d050-477f-878b-4cd73a270a91.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-848-08597260848088 BLISTER PACK in 1 CARTON (59726-848-08) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK8 blister pack2019-06-300000-00-00NoNoCurrent