Kids-EEZE

Product NDC
61941-1005
11-digit product format
619411005
Labeler code
61941
Product ID
61941-1005_185301e7-69c9-43ef-93c1-e6dddeb153ad
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
ProPhase Labs, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-09-01
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
13 mg/1
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 productproduct61941-1005IInactivated by FDA2026-11-03
excluded packagepackage61941-100561941-1005-1IInactivated by FDA2026-11-03

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 packagepackage61941-1005-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61941-1005-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61941-1005-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61941-1005-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61941-1005-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61941-1005-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61941-1005-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61941-1005-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61941-1005-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61941-1005-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61941-1005-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61941-1005-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61941-1005-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61941-1005-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61941-1005-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61941-1005-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61941-1005-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61941-1005-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61941-1005-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61941-1005-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61941-1005-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61941-1005-1110d247fa046…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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61941-1005-12019-10-29C16284748780-1960f7f55-db2c-8e05-e053-dbdaa90a074aKids-EEZE ® Allergy Soft Chews Great Tasting Grape

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61941-1005-1Kids-EEZE Allergy72 in 1 CASETABLET, ORALLY DISINTEGRATING721
61941-1005-6Kids-EEZE Allergy12 in 1 PACKAGETABLET, ORALLY DISINTEGRATING121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40KIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1
DiphenhydramineACTIVE MOIETY8GTS82S83MKIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48KIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1
ETHYLCELLULOSE (4 MPA.S)INACTIVE INGREDIENTKC5472WRJKKIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVKIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PKIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62KIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPKIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4KIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EKIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61941-1005KIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1Legacy NDC, 2 package rows20110601_cf4f599c-f3b2-4e07-8157-1486094ee52b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSNcf4f599c-f3b2-4e07-8157-1486094ee52b1
1111095Kids-EEZE Allergy 12.5 MG Chewable TabletPSNcf4f599c-f3b2-4e07-8157-1486094ee52b1
1111095diphenhydramine hydrochloride 12.5 MG Chewable Tablet [Kids-Eeze Allergy]SBDcf4f599c-f3b2-4e07-8157-1486094ee52b1
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCDcf4f599c-f3b2-4e07-8157-1486094ee52b1
1111095Kids-Eeze Allergy 12.5 MG Chewable TabletSYcf4f599c-f3b2-4e07-8157-1486094ee52b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61941-1005-16194110050172 in 1 CASEHistorical
61941-1005-66194110050612 in 1 PACKAGEHistorical