Benadryl Extra Strength Itch Relief

Product NDC
58232-0742
Requested package NDC
58232-0742-6
11-digit product format
582320742
Labeler code
58232
Product ID
58232-0742_ddc598e7-d3b4-1be9-e053-2995a90ab90b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride and Zinc Acetate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Johnson & Johnson Consumer Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-04-01
Marketing end
2023-02-21
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
20 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58232-074258232-0742-6DDiscontinued 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 · 12 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…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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 INGREDIENTTC2D6JAD40BENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY, DIVISION OF JOHNSON & JOHNSON CONSUMER COMPANIES, INC.]3
Zinc AcetateACTIVE INGREDIENTFM5526K07ABENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY, DIVISION OF JOHNSON & JOHNSON CONSUMER COMPANIES, INC.]3
DiphenhydramineACTIVE MOIETY8GTS82S83MBENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY, DIVISION OF JOHNSON & JOHNSON CONSUMER COMPANIES, INC.]3
Zinc CationACTIVE MOIETY13S1S8SF37BENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY, DIVISION OF JOHNSON & JOHNSON CONSUMER COMPANIES, INC.]3
AlcoholINACTIVE INGREDIENT3K9958V90MBENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY, DIVISION OF JOHNSON & JOHNSON CONSUMER COMPANIES, INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY, DIVISION OF JOHNSON & JOHNSON CONSUMER COMPANIES, INC.]3
PovidonesINACTIVE INGREDIENTFZ989GH94EBENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY, DIVISION OF JOHNSON & JOHNSON CONSUMER COMPANIES, INC.]3
TromethamineINACTIVE INGREDIENT023C2WHX2VBENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY, DIVISION OF JOHNSON & JOHNSON CONSUMER COMPANIES, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RBENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY, DIVISION OF JOHNSON & JOHNSON CONSUMER COMPANIES, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58232-0742-6582320742061 APPLICATOR in 1 CARTON (58232-0742-6) > 14 mL in 1 APPLICATOR1 applicator2012-04-012023-02-21NoNoCurrent