FDA.reportPublic FDA data

Diphenhydramine HCl and Zinc Acetate

Product NDC
36800-126
11-digit product format
368000126
Labeler code
36800
Product ID
36800-126_42f4bfb8-4182-037f-e063-6294a90a9cee
Type
HUMAN OTC DRUG
Nonproprietary name
Extra Strength Itch Relief Continuous Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-05
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
1.5; .075 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 HYDROCHLORIDE1.5 g/76g
ZINC ACETATE.075 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
36800-126-76Diphenhydramine HCl and Zinc Acetate76 g in 1 CANISTERAEROSOL, SPRAY767

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-126DIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 1 package rows20241213_8026c7dd-eb7b-ebea-e053-2991aa0a1b0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN8026c7dd-eb7b-ebea-e053-2991aa0a1b0f7
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD8026c7dd-eb7b-ebea-e053-2991aa0a1b0f7
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY8026c7dd-eb7b-ebea-e053-2991aa0a1b0f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-126-763680001267676 g in 1 CANISTER (36800-126-76) 76 g2019-03-050000-00-00NoNoCurrent