Diphenhydramine HCl and Zinc Acetate

Product NDC
56104-015
11-digit product format
561040015
Labeler code
56104
Product ID
56104-015_c70469a3-4009-78ea-e053-2995a90aa414
Type
HUMAN OTC DRUG
Nonproprietary name
Extra Strength Itch Relief Continuous Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
2 g/88mL; g/88mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct56104-015DDiscontinued by firm2026-10-05
excluded packagepackage56104-01556104-015-03DDiscontinued 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 · 18 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 packagepackage56104-015-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage56104-015-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage56104-015-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage56104-015-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage56104-015-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage56104-015-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage56104-015-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage56104-015-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage56104-015-030efc9e666f02…f202fb6c5f17…

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 INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07ADIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37DIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-015-035610400150388 mL in 1 CANISTER (56104-015-03) 88 ml2013-01-010000-00-00NoNoCurrent