Cold-EEZE

Product NDC
61941-0225
11-digit product format
619410225
Labeler code
61941
Product ID
61941-0225_c1cf8137-5dad-44d8-b08d-5404467e05b0
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Gluconate, Valerian, and Chamomile
Dosage form
KIT
Labeler
ProPhase Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-12-01
Marketing end
0000-00-00
Active strength
0
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 productproduct61941-0225IInactivated by FDA2026-10-15
excluded packagepackage61941-022561941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4IInactivated 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 packagepackage61941-0225-4EExcluded 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
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61941-0225-42020-01-31C16284748780-19d75b9cf-d5fe-f424-e053-dadaa90a57ceCold-EEZE ® Daytime/Nighttime QuickMelts ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61941-0225-4Cold-EEZE Daytime and Nighttime QuickMelts1 in 1 CARTONKIT11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ChamomileACTIVE INGREDIENTFGL3685T2XCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
VALERIANACTIVE INGREDIENTJWF5YAW3QWCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
Zinc GluconateACTIVE INGREDIENTU6WSN5SQ1ZCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
ChamomileACTIVE MOIETYFGL3685T2XCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
VALERIANACTIVE MOIETYJWF5YAW3QWCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
CrospovidoneINACTIVE INGREDIENT68401960MKCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
GlycineINACTIVE INGREDIENTTE7660XO1CCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
STEVIA REBAUDIUNA LEAFINACTIVE INGREDIENT6TC6NN0876COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCOLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61941-0225COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1Legacy NDC, 1 package rows20150114_42739447-8fa8-4f03-9035-2e44671feb04.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61941-0225-4619410225041 in 1 CARTONHistorical