North Antihistamine

Product NDC
0498-0097
11-digit product format
004980097
Labeler code
0498
Product ID
0498-0097_ad849e9a-6e1f-481d-ad72-d5ce453d35c8
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE
Dosage form
TABLET
Route
ORAL
Labeler
Honeywell Safety Products USA, Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-12-02
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0498-0097DDiscontinued by firm2026-08-17
excluded packagepackage0498-00970498-0097-20DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0498-0097-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0498-0097-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0498-0097-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0498-0097-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0498-0097-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0498-0097-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0498-0097-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0498-0097-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0498-0097-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0498-0097-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0498-0097-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0498-0097-20557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40NORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JNORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KNORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KNORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTH ANTIHISTAMINE (DIPHENHYDRAMINE ) TABLET [NORTH SAFETY PRODUCTS]1