Allergy

Product NDC
62011-0058
11-digit product format
620110058
Labeler code
62011
Product ID
62011-0058_481de4bb-5d7e-4155-8629-d9f19de4ca5a
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-05-17
Marketing end
2020-03-30
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 productproduct62011-0058DDiscontinued by firm2026-10-05
excluded packagepackage62011-005862011-0058-1DDiscontinued by firm2026-10-05
excluded packagepackage62011-005862011-0058-3DDiscontinued 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 · 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 packagepackage62011-0058-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0058-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0058-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0058-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0058-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0058-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0058-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0058-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0058-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0058-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0058-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0058-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0058-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0058-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0058-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0058-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0058-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0058-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62011-0058-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62011-0058-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62011-0058-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62011-0058-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62011-0058-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62011-0058-3557ba5c1ecfa…9c80585c8c6e…

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
62011-0058-1EA - Each62011-0058dc32abb5-35f2-47b2-87ce-e783146b953312012-07-24
62011-0058-3EA - Each62011-0058651cbb78-f3e2-43f9-b915-6df86402ea5812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
TALCINACTIVE INGREDIENT7SEV7J4R1UALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3
WATERINACTIVE INGREDIENT059QF0KO0RALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MCKESSON]3