FDA.reportPublic FDA data

CAREALL Anti-Itch

Product NDC
51824-088
11-digit product format
518240088
Labeler code
51824
Product ID
51824-088_44eb4ae2-989d-baba-e063-6394a90a39d2
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride and zinc acetate cream
Dosage form
CREAM
Route
TOPICAL
Labeler
New World Imports, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
20; 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
CAREALL Anti-Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE20 mg/g
ZINC ACETATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, FM5526K07A
Rxcui1087026

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
51824-088-01CAREALL Anti-Itch35 g in 1 TUBECREAM354

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-088-01GM - Gram51824-088e53bd25d-c3fd-4181-a7fd-adf37b3a0f5612023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-088CAREALL ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAM) CREAM [NEW WORLD IMPORTS, INC]3Current NDC, Legacy NDC, 1 package rows20240214_3a01f57a-ebc6-4724-b625-1d1ea4b85e73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN3a01f57a-ebc6-4724-b625-1d1ea4b85e734
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD3a01f57a-ebc6-4724-b625-1d1ea4b85e734
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY3a01f57a-ebc6-4724-b625-1d1ea4b85e734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-088-015182400880135 g in 1 TUBE (51824-088-01) 35 g2022-07-010000-00-00NoNoCurrent