Home NDC 53499-0159 Umcka Cold Flu Berry Chewable
Product NDC 53499-0159
11-digit product format 534990159
Labeler code 53499
Product ID 53499-0159_41af4855-7b47-4184-b826-18263533da72
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 America, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2017-08-21
Marketing end 0000-00-00
Substance ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS
Active strength 4 [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
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53499-0159-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53499-0159-0 f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53499-0159 UMCKA COLD FLU BERRY CHEWABLE (PELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUS) TABLET, CHEWABLE [SCHWABE NORTH AMERICA, INC.] 7 Legacy NDC 20230713_3b483993-48b0-415d-8109-b6b4a48e7cda.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53499-0159-0 53499015900 2 BLISTER PACK in 1 CARTON (53499-0159-0) > 10 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2017-08-21 0000-00-00 No No Current