FDA.reportPublic FDA data

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Product NDC
70677-0144
Requested package NDC
70677-0144-2
11-digit product format
706770144
Labeler code
70677
Product ID
70677-0144_fa1a53b5-1258-41c4-8662-b8e6d3d57ea8
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-04-22
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
13 mg/5mL
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 packagepackage70677-014470677-0144-2DDiscontinued by firm2026-10-15

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 · 6 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…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0144-1ML - Milliliter70677-0144d50457bd-c0d8-473f-a4c0-8170cab381bc12022-09-12
70677-0144-2ML - Milliliter70677-01440b0ec04e-40f2-4711-a1e3-bd1d2d8f358412022-10-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN5c6c1809-4c6f-4e8f-a5ae-9796e821d4006
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD5c6c1809-4c6f-4e8f-a5ae-9796e821d4006
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY5c6c1809-4c6f-4e8f-a5ae-9796e821d4006
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY5c6c1809-4c6f-4e8f-a5ae-9796e821d4006
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY5c6c1809-4c6f-4e8f-a5ae-9796e821d4006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70677-0144-2706770144021 BOTTLE in 1 CARTON (70677-0144-2) > 236 mL in 1 BOTTLE1 bottle2022-05-160000-00-00NoNoCurrent