FDA.reportPublic FDA data

AcetaFlu NightTime Effervescent

Product NDC
13411-841
11-digit product format
134110841
Labeler code
13411
Product ID
13411-841_106498d1-31cc-41e7-a17b-9463fbeb6cb1
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-03-24
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 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
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-841-162022-01-28C16284748780-1d6a99b39-88b2-a426-e053-dadaa90af4c2d5ebda54-8917-4bd7-af47-354432f13cc8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-841-16AcetaFlu NightTime Effervescent4 in 1 BLISTER PACKTABLET, EFFERVESCENT41
13411-841-16AcetaFlu NightTime Effervescent4 in 1 BOXTABLET, EFFERVESCENT41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-841ACETAFLU NIGHTTIME EFFERVESCENT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, EFFERVESCENT [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 2 package rows20200407_d5ebda54-8917-4bd7-af47-354432f13cc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2287739acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Effervescent Oral TabletPSNd5ebda54-8917-4bd7-af47-354432f13cc81
2287739acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Effervescent Oral TabletSCDd5ebda54-8917-4bd7-af47-354432f13cc81
2287739acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Effervescent Oral TabletSYd5ebda54-8917-4bd7-af47-354432f13cc81
2287739APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Effervescent Oral TabletSYd5ebda54-8917-4bd7-af47-354432f13cc81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13411-841-16134110841164 BLISTER PACK in 1 BOX (13411-841-16) > 4 TABLET, EFFERVESCENT in 1 BLISTER PACK4 blister pack2020-03-240000-00-00NoNoCurrent