FDA.reportPublic FDA data

Assured Headache PM (Aspirin Free)

Product NDC
68210-4135
Requested package NDC
68210-4135-2
11-digit product format
682104135
Labeler code
68210
Product ID
68210-4135_ee8ee49e-5b65-ed5a-e053-2a95a90a5840
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Citrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Spirit Pharmaceutical LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-04-28
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE
Active strength
500 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage68210-413568210-4135-2IInactivated by FDA2026-09-09

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4135-2Assured Headache PM (Aspirin Free)1 in 1 CARTONTABLET, COATED16
68210-4135-2Assured Headache PM (Aspirin Free)20 in 1 BOTTLETABLET, COATED206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4135ASSURED HEADACHE PM (ASPIRIN FREE) (ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [SPIRIT PHARMACEUTICAL LLC]6Legacy NDC, 2 package rows20250101_d9d22e45-1a13-4b45-910d-1183a8e6ed7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099872acetaminophen 500 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNd9d22e45-1a13-4b45-910d-1183a8e6ed7d6
1099872acetaminophen 500 MG / diphenhydramine citrate 38 MG Oral TabletSCDd9d22e45-1a13-4b45-910d-1183a8e6ed7d6
1099872APAP 500 MG / Diphenhydramine Citrate 38 MG Oral TabletSYd9d22e45-1a13-4b45-910d-1183a8e6ed7d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4135-2682104135021 BOTTLE in 1 CARTON (68210-4135-2) > 20 TABLET, COATED in 1 BOTTLE1 bottle2021-04-280000-00-00NoNoCurrent