FDA.reportPublic FDA data

Benadryl Original Strength Itch Stopping

Product NDC
69968-0625
11-digit product format
699680625
Labeler code
69968
Product ID
69968-0625_27cdd95f-6e4d-7241-e063-6394a90a5f12
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride and Zinc Acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
10; 1 mg/g; mg/g
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benadryl Original Strength Itch Stopping
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE10 mg/g
ZINC ACETATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, FM5526K07A
Rxcui1292313, 1293717

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0625-1Benadryl Original Strength Itch Stopping28.3 g in 1 TUBECREAM28.37
69968-0625-1Benadryl Original Strength Itch Stopping1 in 1 CARTONCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0625BENADRYL ORIGINAL STRENGTH ITCH STOPPING (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241208_920c50cb-9bdd-4a36-bb3d-c2559db73327.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293717Benadryl Itch Stopping (diphenhydrAMINE HCl 1 % / zinc acetate 0.1 % ) Topical CreamPSN920c50cb-9bdd-4a36-bb3d-c2559db733277
1292313diphenhydrAMINE HCl 1 % / zinc acetate 0.1 % Topical CreamPSN920c50cb-9bdd-4a36-bb3d-c2559db733277
1293717diphenhydramine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]SBD920c50cb-9bdd-4a36-bb3d-c2559db733277
1292313diphenhydramine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD920c50cb-9bdd-4a36-bb3d-c2559db733277
1293717Benadryl Itch Stopping (diphenhydramine HCl 1 % / zinc acetate 0.1 % ) Topical CreamSY920c50cb-9bdd-4a36-bb3d-c2559db733277
1292313diphenhydramine hydrochloride 1 % / zinc acetate 0.1 % Topical CreamSY920c50cb-9bdd-4a36-bb3d-c2559db733277

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0625-1699680625011 TUBE in 1 CARTON (69968-0625-1) / 28.3 g in 1 TUBE1 tube2020-01-310000-00-00NoNoCurrent