Home NDC 53346-1316 DR. RECKEWEG R16 Cimisan
Product NDC 53346-1316
11-digit product format 533461316
Labeler code 53346
Product ID 53346-1316_ae122ddf-a5ea-4887-b6e6-f4393160b430
Type HUMAN OTC DRUG
Nonproprietary name Cimicifuga racemosa 4X, Gelsemium sempervirens 3X, Iris versicolor 2X, Sanguinaria canadensis 3X, Spigelia anthelmia 4X
Dosage form LIQUID
Route ORAL
Labeler PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1986-06-01
Marketing end 0000-00-00
Substance BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA
Active strength 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL
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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 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 53346-1316-5 DR. RECKEWEG R16 CimisanCombination Product 50 mL in 1 BOTTLE LIQUID 50 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BLACK COHOSH ACTIVE INGREDIENT K73E24S6X9 DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 GELSEMIUM SEMPERVIRENS ROOT ACTIVE INGREDIENT 639KR60Q1Q DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 IRIS VERSICOLOR ROOT ACTIVE INGREDIENT X43D4L3DQC DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 SANGUINARIA CANADENSIS ROOT ACTIVE INGREDIENT N9288CD508 DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 SPIGELIA ANTHELMIA ACTIVE INGREDIENT WYT05213GE DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 BLACK COHOSH ACTIVE MOIETY K73E24S6X9 DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 GELSEMIUM SEMPERVIRENS ROOT ACTIVE MOIETY 639KR60Q1Q DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 IRIS VERSICOLOR ROOT ACTIVE MOIETY X43D4L3DQC DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 SANGUINARIA CANADENSIS ROOT ACTIVE MOIETY N9288CD508 DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 SPIGELIA ANTHELMIA ACTIVE MOIETY WYT05213GE DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53346-1316 DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 4X, GELSEMIUM SEMPERVIRENS 3X, IRIS VERSICOLOR 2X, SANGUINARIA CANADENSIS 3X, SPIGELIA ANTHELMIA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO] 1 Legacy NDC, 1 package rows 20130514_e8045873-06cc-4614-b31d-27187bcbcb00.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 53346-1316-5 53346131605 50 mL in 1 BOTTLE 50 ml Historical