FDA.reportPublic FDA data

Pain Reliever and Sleep Aid

Product NDC
68210-4185
Requested package NDC
68210-4185-3
11-digit product format
682104185
Labeler code
68210
Product ID
68210-4185_ef1a7325-7aaf-3ca7-e053-2995a90acc58
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, and Diphenhydramine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-11-22
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
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 packagepackage68210-418568210-4185-3IInactivated by FDA2026-09-14

Reported adverse events (FAERS/openFDA)#

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

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
68210-4185-3Pain Reliever and Sleep Aid30 in 1 POUCHTABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4185PAIN RELIEVER AND SLEEP AID (ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 1 package rows20241215_eea540b9-c2e6-4899-8c7a-7799b45f80fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNeea540b9-c2e6-4899-8c7a-7799b45f80fe5
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDeea540b9-c2e6-4899-8c7a-7799b45f80fe5
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYeea540b9-c2e6-4899-8c7a-7799b45f80fe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4185-36821041850330 TABLET, FILM COATED in 1 POUCH (68210-4185-3) 2021-11-220000-00-00NoNoCurrent