Dr. Reckeweg R10 Klimakteran

Product NDC
53346-1310
11-digit product format
533461310
Labeler code
53346
Product ID
53346-1310_f94cf9a1-c478-496e-adee-54458759ebd2
Type
HUMAN OTC DRUG
Nonproprietary name
Cimicifuga racemosa 6X, Lachesis mutus 12X, Sanguinaria canadensis 6X, Sepia 6X, Sulfuricum acidum 6X
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; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFURIC ACID
Active strength
6 [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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53346-1310IInactivated by FDA2026-10-15
excluded packagepackage53346-131053346-1310-5IInactivated by FDA2026-10-15

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53346-1310-5IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53346-1310-5IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53346-1310-5IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53346-1310-5IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53346-1310-5IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53346-1310-5IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53346-1310-5IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53346-1310-5IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53346-1310-5IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53346-1310-5IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53346-1310-5IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53346-1310-5IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53346-1310-5IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53346-1310-5IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53346-1310-5IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53346-1310-5IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53346-1310-5IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53346-1310-5IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53346-1310-5IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53346-1310-5IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53346-1310-5IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53346-1310-5EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53346-1310-52020-01-31C16284748780-19d75b9cf-d8b3-f424-e053-dadaa90a57ceDr. Reckeweg R10 Klimakteran

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53346-1310-5Dr. Reckeweg R10 KlimakteranCombination Product50 mL in 1 BOTTLELIQUID501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BLACK COHOSHACTIVE INGREDIENTK73E24S6X9DR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07IDR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD508DR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C2DR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1
SULFURIC ACIDACTIVE INGREDIENTO40UQP6WCFDR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1
BLACK COHOSHACTIVE MOIETYK73E24S6X9DR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07IDR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD508DR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C2DR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1
SULFURIC ACIDACTIVE MOIETYO40UQP6WCFDR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1
WATERINACTIVE INGREDIENT059QF0KO0RDR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53346-1310DR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT (CIMICIFUGA RACEMOSA 6X, LACHESIS MUTUS 12X, SANGUINARIA CANADENSIS 6X, SEPIA 6X, SULFURICUM ACIDUM 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1Legacy NDC, 1 package rows20130513_a678cbb1-f4f3-4e4d-a89f-0cff0e4af4d5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53346-1310-55334613100550 mL in 1 BOTTLE50 mlHistorical