Home NDC 57520-0595 Water
Product NDC 57520-0595
11-digit product format 575200595
Labeler code 57520
Product ID 57520-0595_d3471a2c-00f3-40a1-9109-d01c83d1ab6b
Type HUMAN OTC DRUG
Nonproprietary name Betula pendula, cortex, Lappa major, Plantago major, Taraxacum officinale,
Dosage form CAPSULE
Route ORAL
Labeler Apotheca Company
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2011-01-25
Marketing end 0000-00-00
Substance BETULA PENDULA BARK; ARCTIUM LAPPA ROOT; PLANTAGO MAJOR; TARAXACUM OFFICINALE
Active strength 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag E
Listing certified through 2018-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 57520-0595-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 57520-0595-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 57520-0595-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 57520-0595-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 57520-0595-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 57520-0595-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57520-0595-1 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57520-0595-1 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57520-0595-1 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 57520-0595-1 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 57520-0595-1 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57520-0595-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 57520-0595-1 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 57520-0595-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 57520-0595-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 57520-0595-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 57520-0595-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 57520-0595-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 57520-0595-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 57520-0595-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 57520-0595-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 57520-0595-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57520-0595-1 Water X 30 g in 1 BOTTLE CAPSULE 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ARCTIUM LAPPA ROOT ACTIVE INGREDIENT 597E9BI3Z3 WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 BETULA PENDULA BARK ACTIVE INGREDIENT 40S83Y133C WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 PLANTAGO MAJOR ACTIVE INGREDIENT W2469WNO6U WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 TARAXACUM OFFICINALE ACTIVE INGREDIENT 39981FM375 WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 ARCTIUM LAPPA ROOT ACTIVE MOIETY 597E9BI3Z3 WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 BETULA PENDULA BARK ACTIVE MOIETY 40S83Y133C WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 PLANTAGO MAJOR ACTIVE MOIETY W2469WNO6U WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 TARAXACUM OFFICINALE ACTIVE MOIETY 39981FM375 WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 AGATHOSMA BETULINA LEAF INACTIVE INGREDIENT 369DDH39Z0 WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 ARCTIUM LAPPA ROOT INACTIVE INGREDIENT 597E9BI3Z3 WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 BETULA PUBESCENS LEAF INACTIVE INGREDIENT 84SOH0O3OO WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 ELYMUS REPENS ROOT INACTIVE INGREDIENT 3IXW0F6P8W WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 JUNIPERUS COMMUNIS FRUIT INACTIVE INGREDIENT O84B5194RL WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 TARAXACUM OFFICINALE ROOT INACTIVE INGREDIENT 9DE5YCO0RU WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57520-0595 WATER (BETULA PENDULA, CORTEX, LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE,) CAPSULE [APOTHECA COMPANY] 1 Legacy NDC, 1 package rows 20110126_9e9018e1-f874-49f4-8824-5e0f8360e8b0.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 57520-0595-1 57520059501 30 g in 1 BOTTLE 30 g Historical