DR. RECKEWEG R25 Prostatan

Product NDC: 53346-1325
11-digit product format: 533461325
Labeler code: 53346
Product ID: 53346-1325_e7b47449-855c-40f0-8f6d-3fb7d7e04d14
Type: HUMAN OTC DRUG
Nonproprietary name: Chimaphila umbellata 6X, Conium maculatum 6X, Ferrum picricum 6X, Pareira brava 6X, Populus tremuloides 6X, Pulsatilla 6X, Sabal serrulata 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: CHIMAPHILA UMBELLATA; CONIUM MACULATUM FLOWERING TOP; FERRIC PICRATE; CHONDRODENDRON TOMENTOSUM ROOT; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; PULSATILLA PRATENSIS; SAW PALMETTO
Active strength: 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53346-1325		I	Inactivated by FDA		2026-10-05
excluded package	package	53346-1325	53346-1325-5	I	Inactivated by FDA		2026-10-05

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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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	53346-1325-5	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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
04cdd491-d111-4bc2-9549-75c575e1bd4b	Product name	1	20200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73	Product name	1	20200611
96a528e9-23e2-495f-81b9-ae87df2f7552	Product name	1	20191120
3df56c93-5837-4523-aac2-4b1ec48b9676	Product name	2	20160719
a883b7cc-d320-41d7-92ae-c873457ae641	Product name	1	20151116
bb23e78e-9e64-4037-a1c1-0e1d8762700e	Product name	1	20150325
ef06c001-572c-d95e-42f6-ee83da75673a	Product name	1	20140508
fd21f957-6863-d07b-5a35-250186878716	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53346-1325-5	2020-01-31	C162847	48780-1	9d75b9cf-d8b9-f424-e053-dadaa90a57ce	DR. RECKEWEG R25 Prostatan

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53346-1325-5	DR. RECKEWEG R25 ProstatanCombination Product	50 mL in 1 BOTTLE	LIQUID	50		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHIMAPHILA UMBELLATA	ACTIVE INGREDIENT	WCK21A9W9J	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
CHONDRODENDRON TOMENTOSUM ROOT	ACTIVE INGREDIENT	395A3P448Z	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
CONIUM MACULATUM FLOWERING TOP	ACTIVE INGREDIENT	Q28R5GF371	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
FERRIC PICRATE	ACTIVE INGREDIENT	KZM8ZRY36A	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
POPULUS TREMULOIDES BARK	ACTIVE INGREDIENT	5543O0CEID	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
POPULUS TREMULOIDES LEAF	ACTIVE INGREDIENT	7IIH57D9E0	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
PULSATILLA PRATENSIS	ACTIVE INGREDIENT	8E272251DI	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
SAW PALMETTO	ACTIVE INGREDIENT	J7WWH9M8QS	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
CHIMAPHILA UMBELLATA	ACTIVE MOIETY	WCK21A9W9J	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
CHONDRODENDRON TOMENTOSUM ROOT	ACTIVE MOIETY	395A3P448Z	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
CONIUM MACULATUM FLOWERING TOP	ACTIVE MOIETY	Q28R5GF371	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
FERRIC CATION	ACTIVE MOIETY	91O4LML611	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
POPULUS TREMULOIDES BARK	ACTIVE MOIETY	5543O0CEID	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
POPULUS TREMULOIDES LEAF	ACTIVE MOIETY	7IIH57D9E0	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
PULSATILLA PRATENSIS	ACTIVE MOIETY	8E272251DI	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
SAW PALMETTO	ACTIVE MOIETY	J7WWH9M8QS	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) 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
53346-1325	DR. RECKEWEG R25 PROSTATAN COMBINATION PRODUCT (CHIMAPHILA UMBELLATA 6X, CONIUM MACULATUM 6X, FERRUM PICRICUM 6X, PAREIRA BRAVA 6X, POPULUS TREMULOIDES 6X, PULSATILLA 6X, SABAL SERRULATA 6X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]	1	Legacy NDC, 1 package rows	20130514_bd7f2f38-e44d-4795-a024-a48e650ad3c9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WCK21A9W9J	CHIMAPHILA UMBELLATA		CHIMAPHILA UMBELLATA
Q28R5GF371	CONIUM MACULATUM FLOWERING TOP		CONIUM MACULATUM FLOWERING TOP
KZM8ZRY36A	FERRIC PICRATE	20255-23-6	FERRIC PICRATE
395A3P448Z	CHONDRODENDRON TOMENTOSUM ROOT		CHONDRODENDRON TOMENTOSUM ROOT
5543O0CEID	POPULUS TREMULOIDES BARK		POPULUS TREMULOIDES BARK
7IIH57D9E0	POPULUS TREMULOIDES LEAF		POPULUS TREMULOIDES LEAF
J7WWH9M8QS	SAW PALMETTO		SAW PALMETTO

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53346-1325-5	53346132505	50 mL in 1 BOTTLE	50 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DR. RECKEWEG R25 Prostatan	PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO	2013-04-04	HUMAN OTC DRUG LABEL	1