Home NDC 52053-0001 Sambucol Cold and Flu Relief
Product NDC 52053-0001
11-digit product format 520530001
Labeler code 52053
Product ID 52053-0001_bf3dfdcd-0427-46ad-aa29-60e5b1fa0089
Type HUMAN OTC DRUG
Nonproprietary name Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum
Dosage form TABLET, ORALLY DISINTEGRATING
Route ORAL
Labeler PharmaCare US, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2013-03-26
Substance BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; ZINC GLUCONATE
Active strength 6; 6; 3; 12; 2 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 30 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 52053-0001-4 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 52053-0001-4 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52053-0001-4 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52053-0001-4 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52053-0001-4 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52053-0001-4 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52053-0001-4 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52053-0001-4 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52053-0001-4 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52053-0001-4 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52053-0001-4 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52053-0001-4 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 52053-0001-4 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 52053-0001-4 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 52053-0001-4 1332a3947898…d4bfe170f9cd…
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 Sambucol Cold and Flu Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRYONIA ALBA ROOT 6 [hp_X]/mg GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]/mg SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X]/mg SULFUR 12 [hp_X]/mg ZINC GLUCONATE 2 [hp_X]/mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52053-0001-1 Sambucol Cold and Flu Relief 4500 mg in 1 BLISTER PACK TABLET, ORALLY DISINTEGRATING 4500 10 52053-0001-2 Sambucol Cold and Flu Relief 2 in 1 CARTON TABLET, ORALLY DISINTEGRATING 2 10 52053-0001-4 Sambucol Cold and Flu Relief 6 in 1 CARTON TABLET, ORALLY DISINTEGRATING 6 2 52053-0001-4 Sambucol Cold and Flu Relief 4500 mg in 1 BLISTER PACK TABLET, ORALLY DISINTEGRATING 4500 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BRYONIA ALBA ROOT ACTIVE INGREDIENT T7J046YI2B SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 GELSEMIUM SEMPERVIRENS ROOT ACTIVE INGREDIENT 639KR60Q1Q SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 SAMBUCUS NIGRA FLOWERING TOP ACTIVE INGREDIENT CT03BSA18U SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 SULFUR ACTIVE INGREDIENT 70FD1KFU70 SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 ZINC GLUCONATE ACTIVE INGREDIENT U6WSN5SQ1Z SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 BRYONIA ALBA ROOT ACTIVE MOIETY T7J046YI2B SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 GELSEMIUM SEMPERVIRENS ROOT ACTIVE MOIETY 639KR60Q1Q SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 SAMBUCUS NIGRA FLOWERING TOP ACTIVE MOIETY CT03BSA18U SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 SULFUR ACTIVE MOIETY 70FD1KFU70 SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 BLACK CARROT ANTHOCYANINS INACTIVE INGREDIENT 971DA56IOL SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 EUROPEAN ELDERBERRY JUICE INACTIVE INGREDIENT Z4IFJ0AK1E SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52053-0001 SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20241105_4dc2088f-3f13-4e49-83e4-44c2a26d195f.zip 52053-0001 SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20220413_ce66e57d-ae46-0973-e053-2a95a90a6165.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52053-0001-1 52053000101 4500 mg in 1 BLISTER PACK 4500 mg Historical 52053-0001-2 52053000102 2 BLISTER PACK in 1 CARTON (52053-0001-2) / 4500 mg in 1 BLISTER PACK (52053-0001-1) 2 blister pack 2017-06-30 0000-00-00 No No Current 52053-0001-4 52053000104 6 BLISTER PACK in 1 CARTON (52053-0001-4) > 4500 mg in 1 BLISTER PACK 6 blister pack 2021-10-15 0000-00-00 No No Current