FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
60760-332
11-digit product format
607600332
Labeler code
60760
Product ID
60760-332_a0967588-5008-2cdf-e053-2995a90a2b42
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-03-11
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60760-332DDiscontinued by firm2026-10-05
excluded packagepackage60760-33260760-332-30DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-332-30EA - Each60760-33222044bc2-91a5-4c74-96a3-a2d96d90b04412020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-332DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]2Legacy NDC20231219_a0968b34-280d-a644-e053-2a95a90a4c58.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-332-306076003323030 CAPSULE in 1 BOTTLE, PLASTIC (60760-332-30) 30 capsule2020-03-110000-00-00NoNoCurrent