Anti-Itch

Product NDC
29500-2437
11-digit product format
295002437
Labeler code
29500
Product ID
29500-2437_69bf5fe2-9930-4fbb-a2d0-6a61f46dbfbf
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Personal Care Products, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-07-10
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
700 mg/35g; mg/35g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct29500-2437IInactivated by FDA2026-10-15
excluded packagepackage29500-243729500-2437-1IInactivated by FDA2026-10-15

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage29500-2437-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage29500-2437-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage29500-2437-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage29500-2437-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage29500-2437-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage29500-2437-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage29500-2437-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage29500-2437-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage29500-2437-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage29500-2437-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage29500-2437-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage29500-2437-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage29500-2437-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage29500-2437-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage29500-2437-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage29500-2437-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage29500-2437-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage29500-2437-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage29500-2437-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage29500-2437-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage29500-2437-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage29500-2437-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
29500-2437-12020-01-31C16284748780-19d75b9d0-9742-f424-e053-dadaa90a57cebfa57f40-a1f4-4b53-95d5-1d6d6ed0233f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29500-2437-1Anti-ItchExtra Strength35 g in 1 TUBECREAM351

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07AANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37ANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4ANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1
PEG-2 STEARATEINACTIVE INGREDIENT94YQ11Y95FANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1
PEG-20 STEARATEINACTIVE INGREDIENTNBX892EA57ANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29500-2437ANTI-ITCH EXTRA STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERSONAL CARE PRODUCTS, INC.]1Legacy NDC, 1 package rows20130724_bfa57f40-a1f4-4b53-95d5-1d6d6ed0233f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNbfa57f40-a1f4-4b53-95d5-1d6d6ed0233f1
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDbfa57f40-a1f4-4b53-95d5-1d6d6ed0233f1
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSYbfa57f40-a1f4-4b53-95d5-1d6d6ed0233f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
29500-2437-12950024370135 g in 1 TUBE35 gHistorical