Anti itch Topical Analgesic

Product NDC
63868-218
11-digit product format
638680218
Labeler code
63868
Product ID
63868-218_9a14c831-7437-84b0-e053-2995a90af7ba
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride, Zinc Acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Chain Drug Marketing Associations Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-02-20
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
2 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-218DDiscontinued by firm2026-10-12
excluded packagepackage63868-21863868-218-01DDiscontinued by firm2026-10-12

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 · 40 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63868-218-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63868-218-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63868-218-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63868-218-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63868-218-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63868-218-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63868-218-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63868-218-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63868-218-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63868-218-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63868-218-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63868-218-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63868-218-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63868-218-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63868-218-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63868-218-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63868-218-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63868-218-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63868-218-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63868-218-01e2bbac7714bc…27bdfed8d636…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-218-01Anti itch Topical Analgesic28 g in 1 TUBECREAM285
63868-218-01Anti itch Topical Analgesic1 in 1 BOXCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-218-01GM - Gram63868-2189519dbdf-88b1-4890-991d-418fa36773b412014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07AANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]1
ZINC CATIONACTIVE MOIETY13S1S8SF37ANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-218ANTI ITCH TOPICAL ANALGESIC (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATIONS INC]5Legacy NDC, 2 package rows20191220_85ebd147-9684-4126-a4e6-d0f1046c3ac1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN85ebd147-9684-4126-a4e6-d0f1046c3ac15
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD85ebd147-9684-4126-a4e6-d0f1046c3ac15
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY85ebd147-9684-4126-a4e6-d0f1046c3ac15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63868-218-016386802180128 g in 1 TUBE28 gHistorical