Bed Wetting prevention

Product NDC: 57955-0012
11-digit product format: 579550012
Labeler code: 57955
Product ID: 57955-0012_edc11c38-4f5f-4ad4-ad22-26dd26c9b00a
Type: HUMAN OTC DRUG
Nonproprietary name: Belladonna, Bellis perennis, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago Major, Rhus aromatica, Sepia
Dosage form: LIQUID
Route: ORAL
Labeler: King Bio Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2015-08-31
Marketing end: 0000-00-00
Substance: ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE
Active strength: 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
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	57955-0012		I	Inactivated by FDA		2026-08-17
excluded package	package	57955-0012	57955-0012-2	I	Inactivated by FDA		2026-08-17

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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	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	57955-0012-2	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57955-0012-2	2020-01-31	C162847	48780-1	9d75b9d0-b97a-f424-e053-dadaa90a57ce	Bed Wetting Prevention

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57955-0012-2	Bed Wetting prevention	59 mL in 1 BOTTLE, SPRAY	LIQUID	59		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
BELLIS PERENNIS	ACTIVE INGREDIENT	2HU33I03UY	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
BENZOIC ACID	ACTIVE INGREDIENT	8SKN0B0MIM	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
CAUSTICUM	ACTIVE INGREDIENT	DD5FO1WKFU	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
EQUISETUM HYEMALE	ACTIVE INGREDIENT	59677RXH25	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
LYCOPODIUM CLAVATUM SPORE	ACTIVE INGREDIENT	C88X29Y479	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
PHOSPHORUS	ACTIVE INGREDIENT	27YLU75U4W	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
PLANTAGO MAJOR	ACTIVE INGREDIENT	W2469WNO6U	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
RHUS AROMATICA ROOT BARK	ACTIVE INGREDIENT	Q3H36W0J42	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
SEPIA OFFICINALIS JUICE	ACTIVE INGREDIENT	QDL83WN8C2	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
BELLIS PERENNIS	ACTIVE MOIETY	2HU33I03UY	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
BENZOIC ACID	ACTIVE MOIETY	8SKN0B0MIM	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
CAUSTICUM	ACTIVE MOIETY	DD5FO1WKFU	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
EQUISETUM HYEMALE	ACTIVE MOIETY	59677RXH25	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
LYCOPODIUM CLAVATUM SPORE	ACTIVE MOIETY	C88X29Y479	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
PHOSPHORUS	ACTIVE MOIETY	27YLU75U4W	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
PLANTAGO MAJOR	ACTIVE MOIETY	W2469WNO6U	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
RHUS AROMATICA ROOT BARK	ACTIVE MOIETY	Q3H36W0J42	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
SEPIA OFFICINALIS JUICE	ACTIVE MOIETY	QDL83WN8C2	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57955-0012	BED WETTING PREVENTION (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]	3	Legacy NDC, 1 package rows	20161109_b4a9134d-b1ef-4940-b413-d15be28e03b5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WQZ3G9PF0H	ATROPA BELLADONNA		ATROPA BELLADONNA
2HU33I03UY	BELLIS PERENNIS		BELLIS PERENNIS
8SKN0B0MIM	BENZOIC ACID	65-85-0	BENZOIC ACID
DD5FO1WKFU	CAUSTICUM		CAUSTICUM
59677RXH25	EQUISETUM HYEMALE		EQUISETUM HYEMALE
C88X29Y479	LYCOPODIUM CLAVATUM SPORE	8023-70-9	LYCOPODIUM CLAVATUM SPORE
27YLU75U4W	PHOSPHORUS	7723-14-0	PHOSPHORUS
W2469WNO6U	PLANTAGO MAJOR		PLANTAGO MAJOR
Q3H36W0J42	RHUS AROMATICA ROOT BARK		RHUS AROMATICA ROOT BARK
QDL83WN8C2	SEPIA OFFICINALIS JUICE		SEPIA OFFICINALIS JUICE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
57955-0012-2	57955001202	59 mL in 1 BOTTLE, SPRAY	59 ml	Historical