Anti Itch Cream

Product NDC
51141-0054
11-digit product format
511410054
Labeler code
51141
Product ID
51141-0054_7b5b52f3-182a-4f8e-b877-68cc5e5201d1
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl, Zinc acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
NeoPharm Co., Ltd.
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-09-07
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
2 g/100g; g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51141-0054IInactivated by FDA2026-10-05
excluded packagepackage51141-005451141-0054-1IInactivated by FDA2026-10-05
excluded packagepackage51141-005451141-0054-2IInactivated by FDA2026-10-05

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 2 · 66 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 packagepackage51141-0054-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51141-0054-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51141-0054-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51141-0054-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51141-0054-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51141-0054-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51141-0054-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51141-0054-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51141-0054-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51141-0054-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51141-0054-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51141-0054-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51141-0054-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51141-0054-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51141-0054-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51141-0054-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51141-0054-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51141-0054-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51141-0054-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51141-0054-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51141-0054-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51141-0054-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51141-0054-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51141-0054-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51141-0054-28af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51141-0054-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51141-0054-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51141-0054-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51141-0054-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51141-0054-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51141-0054-1fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51141-0054-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51141-0054-186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51141-0054-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51141-0054-1bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51141-0054-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51141-0054-18dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51141-0054-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51141-0054-1e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51141-0054-2e2bbac7714bc…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
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51141-0054-12019-10-21C16284748780-1956f9ecf-d035-621f-e053-dbdaa90a74adDrug Facts
51141-0054-22019-10-21C16284748780-1956f9ecf-d035-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51141-0054-1Anti Itch Cream1 in 1 BOXCREAM11
51141-0054-1Anti Itch Cream28 g in 1 TUBECREAM281
51141-0054-2Anti Itch Cream1 in 1 BOXCREAM11
51141-0054-2Anti Itch Cream57 g in 1 TUBECREAM571

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07AANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
ZINCACTIVE MOIETYJ41CSQ7QDSANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51141-0054ANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]1Legacy NDC, 4 package rows20100907_0fcf2d98-991e-4a66-8f82-ec48df01310d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN0fcf2d98-991e-4a66-8f82-ec48df01310d1
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD0fcf2d98-991e-4a66-8f82-ec48df01310d1
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY0fcf2d98-991e-4a66-8f82-ec48df01310d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51141-0054-1511410054011 in 1 BOXHistorical
51141-0054-2511410054021 in 1 BOXHistorical