FDA.reportPublic FDA data

MAXIMUM STRENGTH SLEEP AID

Product NDC
68210-4099
11-digit product format
682104099
Labeler code
68210
Product ID
68210-4099_eeca6dcf-c8c5-7cf9-e053-2995a90a936a
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HCl
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS LLC
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-02
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-4099IInactivated by FDA2026-10-05
excluded packagepackage68210-409968210-4099-1IInactivated by FDA2026-10-05

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
68210-4099-1MAXIMUM STRENGTH SLEEP AID100 in 1 BOTTLECAPSULE, GELATIN COATED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4099MAXIMUM STRENGTH SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [SPIRIT PHARMACEUTICALS LLC]6Legacy NDC, 1 package rows20241215_cee5f4b1-613f-4e49-a29a-6d4c4bd5df18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNcee5f4b1-613f-4e49-a29a-6d4c4bd5df186
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDcee5f4b1-613f-4e49-a29a-6d4c4bd5df186
1020477diphenhydramine HCl 50 MG Oral CapsuleSYcee5f4b1-613f-4e49-a29a-6d4c4bd5df186

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4099-168210409901100 CAPSULE, GELATIN COATED in 1 BOTTLE (68210-4099-1) 2020-07-020000-00-00NoNoCurrent