FDA.reportPublic FDA data

Pharbedryl

Product NDC
50090-1638
Requested package NDC
50090-1638-3
11-digit product format
500901638
Labeler code
50090
Product ID
50090-1638_10fc2a98-6c58-406f-bde3-c0fb4553a0b8
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-02-01
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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 packagepackage50090-163850090-1638-3DDiscontinued by firm2026-10-12

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-1638-02020-02-14Drug Facts
50090-1638-12020-02-14Drug Facts
50090-1638-22020-02-14Drug Facts
50090-1638-32020-02-14Drug Facts
50090-1638-82020-02-14Drug Facts
50090-1638-02020-01-31Drug Facts
50090-1638-12020-01-31Drug Facts
50090-1638-22020-01-31Drug Facts
50090-1638-32020-01-31Drug Facts
50090-1638-82020-01-31Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1638-0EA - Each50090-16386e13795f-c49e-4ea9-b974-5d6f345a558b12018-08-13
50090-1638-1EA - Each50090-1638159ef4a5-65d8-4c2d-998b-24c1191bbae812018-08-13
50090-1638-2EA - Each50090-1638bbf1a35f-1c23-4237-8954-7cae402ff96112018-08-13
50090-1638-3EA - Each50090-16382f51f7d7-3aad-4663-8e8e-62db2410770612018-08-13
50090-1638-8EA - Each50090-16387383ee7e-9385-4c6a-b519-ebd30079dc7b12018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1638-35009016380320 CAPSULE in 1 BOTTLE (50090-1638-3) 20 capsule2016-02-010000-00-00NoNoCurrent