FDA.reportPublic FDA data

Umcka ColdCare Childrens Cherry

Product NDC
53499-0165
11-digit product format
534990165
Labeler code
53499
Product ID
53499-0165_9de4f1b7-f570-4ebc-be25-5fc21eb2ca52
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/120mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct53499-0165DDiscontinued by firm2026-08-17
excluded packagepackage53499-016553499-0165-5DDiscontinued by firm2026-08-17

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 · 4 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 packagepackage53499-0165-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53499-0165-5f5e01cc5f278…a2eaf40c39c3…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PELARGONIUM SIDOIDES ROOTACTIVE INGREDIENTH6J53HEX8EUMCKA COLDCARE CHILDRENS CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
PELARGONIUM SIDOIDES ROOTACTIVE MOIETYH6J53HEX8EUMCKA COLDCARE CHILDRENS CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
ARONIA MELANOCARPA FRUIT JUICEINACTIVE INGREDIENTD2EVP827PJUMCKA COLDCARE CHILDRENS CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPUMCKA COLDCARE CHILDRENS CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVUMCKA COLDCARE CHILDRENS CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DUMCKA COLDCARE CHILDRENS CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RUMCKA COLDCARE CHILDRENS CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-0165-5534990165051 BOTTLE, PLASTIC in 1 CARTON (53499-0165-5) > 120 mL in 1 BOTTLE, PLASTIC2009-09-010000-00-00NoNoCurrent