healthy accents allergy relief

Product NDC
55316-479
11-digit product format
553160479
Labeler code
55316
Product ID
55316-479_91220316-c268-4965-b75c-ede668fccc8e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
DZA Brands LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2008-01-29
Marketing end
2020-03-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55316-479DDiscontinued by firm2026-10-12
excluded packagepackage55316-47955316-479-62DDiscontinued by firm2026-10-12
excluded packagepackage55316-47955316-479-78DDiscontinued 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 · 36 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 packagepackage55316-479-62d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55316-479-78d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-479-62f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-479-78f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-479-622ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-479-782ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-479-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-479-78a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-479-62cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-479-78cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-479-62cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-479-78cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-479-62302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-479-78302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-479-62ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-479-78ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-479-620efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-479-780efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-479-62ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-479-78ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55316-479-62367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55316-479-78367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55316-479-62557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55316-479-78557ba5c1ecfa…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 INGREDIENTTC2D6JAD40HEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MHEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JHEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEALTHY ACCENTS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DZA BRANDS LLC]2