FDA.reportPublic FDA data

allergy

Product NDC
56062-462
Requested package NDC
56062-462-67
11-digit product format
560620462
Labeler code
56062
Product ID
56062-462_c3bb7947-f335-41ab-8ecb-83c1cf8d95c5
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Publix Super Markets Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1993-08-31
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage56062-46256062-462-67DDiscontinued 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 · 11 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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
56062-462-622024-01-30C16284748780-11030e365-4a71-111a-e063-dadaa90a10e2Publix Super Markets, Inc. Allergy Capsules Drug Facts
56062-462-672024-01-30C16284748780-11030e365-4a71-111a-e063-dadaa90a10e2Publix Super Markets, Inc. Allergy Capsules Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
56062-462-62EA - Each56062-46215944b06-8776-4391-ba5d-684fa1f1ec1d12012-07-24
56062-462-67EA - Each56062-462aa8d87c3-67e0-4ec0-b28a-94066d32dcb012022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
GELATININACTIVE INGREDIENT2G86QN327LALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PUBLIX SUPER MARKETS INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-462-675606204626748 BLISTER PACK in 1 CARTON (56062-462-67) > 1 CAPSULE in 1 BLISTER PACK48 blister pack2002-04-180000-00-00NoNoCurrent