FDA.reportPublic FDA data

DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC
61919-079
Requested package NDC
61919-079-30
11-digit product format
619190079
Labeler code
61919
Product ID
61919-079_b9469dad-3958-2e41-e053-2a95a90abd26
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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 packagepackage61919-07961919-079-30DDiscontinued 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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
61919-079-30EA - Each61919-079b3acb0f0-903c-4e12-bcfb-0b95be7e363212014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-079-306191900793030 CAPSULE in 1 BOTTLE (61919-079-30) 30 capsule2015-01-010000-00-00NoNoCurrent