Home NDC 55700-580-30 Diphenhydramine Hydrochloride
Product NDC 55700-580
Requested package NDC 55700-580-30
11-digit product format 557000580
Labeler code 55700
Product ID 55700-580_c62fc0e8-34e2-47a2-b88c-4792e147373f
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application part336
Marketing category OTC MONOGRAPH FINAL
Marketing start 2018-01-12
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55700-580 55700-580-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55700-580 55700-580-30 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55700-580-30 55700058030 30 CAPSULE in 1 BOTTLE (55700-580-30) 30 capsule 2018-01-12 0000-00-00 No No Current