QUALITY CHOICE EXTRA STRENGTH ANTI ITCH

Product NDC
63868-947
11-digit product format
638680947
Labeler code
63868
Product ID
63868-947_53c9d44d-7fd1-4aaa-89d7-2fa8c10e26ad
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Dosage form
CREAM
Route
TOPICAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-02-13
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-947IInactivated by FDA2026-10-12
excluded packagepackage63868-94763868-947-30IInactivated by FDA2026-10-12

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 · 44 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 packagepackage63868-947-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63868-947-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63868-947-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63868-947-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63868-947-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63868-947-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63868-947-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63868-947-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63868-947-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63868-947-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63868-947-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63868-947-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63868-947-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63868-947-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63868-947-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63868-947-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63868-947-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63868-947-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63868-947-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63868-947-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63868-947-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63868-947-30110d247fa046…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
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
63868-947-302019-11-13C16284748780-197449f38-c2d5-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-947-30QUALITY CHOICE EXTRA STRENGTH ANTI ITCH30 g in 1 TUBECREAM301
63868-947-30QUALITY CHOICE EXTRA STRENGTH ANTI ITCH1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40QUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07AQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
ZINCACTIVE MOIETYJ41CSQ7QDSQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1
WATERINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-947QUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]1Legacy NDC, 2 package rows20120228_6b99d52d-6e5f-4b5f-beae-bb1107007163.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN6b99d52d-6e5f-4b5f-beae-bb11070071631
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD6b99d52d-6e5f-4b5f-beae-bb11070071631
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY6b99d52d-6e5f-4b5f-beae-bb11070071631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63868-947-306386809473030 g in 1 TUBE30 gHistorical