FDA.reportPublic FDA data

Allergy

Product NDC
59726-691
Requested package NDC
59726-691-01
11-digit product format
597260691
Labeler code
59726
Product ID
59726-691_4f8fcdaa-db29-4525-9b61-39ae2ae0a815
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
P & L Development, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-08-27
Marketing end
2024-01-05
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage59726-69159726-691-01DDiscontinued 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 · 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.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
TALCINACTIVE INGREDIENT7SEV7J4R1UALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
WATERINACTIVE INGREDIENT059QF0KO0RALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59726-691-01597260691011 BOTTLE, PLASTIC in 1 BOX (59726-691-01) > 100 TABLET in 1 BOTTLE, PLASTIC2013-08-272024-01-05NoNoCurrent