FDA.reportPublic FDA data

TopCare Health Cold Remedy

Product NDC
36800-805
Requested package NDC
36800-805-25
11-digit product format
368000805
Labeler code
36800
Product ID
36800-805_e4a54742-20d4-42b0-a742-e0ca8876c60d
Type
HUMAN OTC DRUG
Nonproprietary name
Zincum Gluconicum
Dosage form
TABLET
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-04-17
Substance
ZINC GLUCONATE
Active strength
1 [hp_X]/1
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare Health Cold Remedy
Brand name suffix
Cherry Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC GLUCONATE1 [hp_X]/1

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-805-25TopCare Health Cold RemedyCherry Flavor25 in 1 BOTTLE, PLASTICTABLET257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-805TOPCARE HEALTH COLD REMEDY CHERRY FLAVOR (ZINCUM GLUCONICUM) TABLET [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 1 package rows20241107_45823465-2c57-4cc1-a44d-1649fb7f3f63.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Health Cold Remedy Cherry FlavorZINCUM GLUCONICUMTOPCO ASSOCIATES LLC45823465-2c57-4cc1-a44d-1649fb7f3f632025-11-10WarningsExact identifier
ndc (package): 36800-805-25
ndc (product): 36800-805
ndc11 (package): 36800080525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-805-253680008052525 TABLET in 1 BOTTLE, PLASTIC (36800-805-25) 25 tablet2019-04-170000-00-00NoNoCurrent