FDA.reportPublic FDA data

Diphenhydramine HCl and Zinc Acetate

Product NDC
37808-526
11-digit product format
378080526
Labeler code
37808
Product ID
37808-526_42653e08-8894-9563-e063-6394a90a5e77
Type
HUMAN OTC DRUG
Nonproprietary name
Extra Strength Itch Relief
Dosage form
SPRAY
Route
TOPICAL
Labeler
HEB
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-22
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
1.52; .076 g/76g; g/76g
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
Diphenhydramine HCl and Zinc Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE1.52 g/76g
ZINC ACETATE.076 g/76g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, FM5526K07A
Rxcui1053138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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
37808-526-27Diphenhydramine HCl and Zinc Acetate76 g in 1 CANSPRAY767

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-526DIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [HEB]6Current NDC, Legacy NDC, 1 package rows20241212_2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f7
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f7
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-526-273780805262776 g in 1 CAN (37808-526-27) 76 g2017-12-220000-00-00NoNoCurrent