Diphenhydramine Hydrochloride

Product NDC
70000-0207
Requested package NDC
70000-0207-1
11-digit product format
700000207
Labeler code
70000
Product ID
70000-0207_c4fcd8bc-0bb7-c0a3-e053-2995a90a8b49
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-01-13
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage70000-020770000-0207-1DDiscontinued by firm2026-10-05

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70000-020770000-0207-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
70000-0207-1EA - Each70000-020773ef5e69-b13a-4adb-a8f0-5eaf94405f4312017-11-06
70000-0207-2EA - Each70000-0207891bca17-6cfd-411a-b7d2-dfad8f83f3f112017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0207DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [LEADER/ CARDINAL HEALTH 110, INC.]7Legacy NDC20250212_2e3b4e65-d090-4e44-9c03-60c3064b74fa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0207-1700000207012 BLISTER PACK in 1 CARTON (70000-0207-1) > 12 CAPSULE in 1 BLISTER PACK2 blister pack2017-01-310000-00-00NoNoCurrent