Umcka Cold Flu Orange

Product NDC: 53499-9161
11-digit product format: 534999161
Labeler code: 53499
Product ID: 53499-9161_161d147b-8e56-4f76-91ac-abfea8ca1932
Type: HUMAN OTC DRUG
Nonproprietary name: Pelargonium sidoides, Aconitum napellus, Bryonia, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Ipecacuanha, Phosphorus
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Schwabe North Amertica, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2017-09-08
Marketing end: 2026-05-31
Substance: ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS
Active strength: 4; 4; 2; 6; 4; 3; 1; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53499-9161		D	Discontinued by firm		2026-07-31
excluded package	package	53499-9161	53499-9161-0	D	Discontinued by firm		2026-07-31

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53499-9161-0	Umcka Cold Flu Orange	2 in 1 CARTON	TABLET, CHEWABLE	2		8
53499-9161-0	Umcka Cold Flu Orange	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10		8

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53499-9161	UMCKA COLD FLU ORANGE (PELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUS) TABLET, CHEWABLE [SCHWABE NORTH AMERTICA, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20241027_a2798927-c92d-40b1-b93d-5391a70d7963.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U0NQ8555JD	ACONITUM NAPELLUS		ACONITUM NAPELLUS
T7J046YI2B	BRYONIA ALBA ROOT		BRYONIA ALBA ROOT
S546YLW6E6	EUCALYPTUS GLOBULUS LEAF		EUCALYPTUS GLOBULUS LEAF
1W0775VX6E	EUPATORIUM PERFOLIATUM FLOWERING TOP		EUPATORIUM PERFOLIATUM FLOWERING TOP
639KR60Q1Q	GELSEMIUM SEMPERVIRENS ROOT		GELSEMIUM SEMPERVIRENS ROOT
62I3C8233L	IPECAC	8012-96-2	IPECAC
H6J53HEX8E	PELARGONIUM SIDOIDES ROOT		PELARGONIUM SIDOIDES ROOT
27YLU75U4W	PHOSPHORUS	7723-14-0	PHOSPHORUS

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53499-9161-0	53499916100	2 BLISTER PACK in 1 CARTON (53499-9161-0) / 10 TABLET, CHEWABLE in 1 BLISTER PACK	2 blister pack	2017-09-08	2026-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Umcka Cold + Flu Orange Chewables	Schwabe North Amertica, Inc. \| Schwabe North America, Inc.	2024-10-25	HUMAN OTC DRUG LABEL	8