Newborn Tonic

Product NDC: 57955-5114
11-digit product format: 579555114
Labeler code: 57955
Product ID: 57955-5114_43d69ea8-6fa0-4107-8d28-09ad35ae3926
Type: HUMAN OTC DRUG
Nonproprietary name: Aconitum napellus, Bovista, Bryonia, Chamomilla, Cinchona officinalis, Lupulinum, Mercurius vivus, Myrica cerifera, Natrum sulphuricum, Phosphorus, Sepia
Dosage form: LIQUID
Route: ORAL
Labeler: King Bio Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2014-03-20
Marketing end: 0000-00-00
Substance: ACONITUM NAPELLUS; LYCOPERDON UTRIFORME FRUITING BODY; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; HOPS; MERCURY; MORELLA CERIFERA ROOT BARK; SODIUM SULFATE; PHOSPHORUS; 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; [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	57955-5114		I	Inactivated by FDA		2026-10-05
excluded package	package	57955-5114	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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	57955-5114-2	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
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57955-5114-2	2020-01-31	C162847	48780-1	9d75b9d0-4a29-f424-e053-dadaa90a57ce	Newborn Tonic™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57955-5114-2	Newborn Tonic	59 mL in 1 BOTTLE, SPRAY	LIQUID	59		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACONITUM NAPELLUS	ACTIVE INGREDIENT	U0NQ8555JD	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
BRYONIA ALBA ROOT	ACTIVE INGREDIENT	T7J046YI2B	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
CINCHONA OFFICINALIS BARK	ACTIVE INGREDIENT	S003A158SB	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
HOPS	ACTIVE INGREDIENT	01G73H6H83	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
LYCOPERDON UTRIFORME FRUITING BODY	ACTIVE INGREDIENT	K2A74U428F	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
MERCURY	ACTIVE INGREDIENT	FXS1BY2PGL	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
MORELLA CERIFERA ROOT BARK	ACTIVE INGREDIENT	S46HJ3710D	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
PHOSPHORUS	ACTIVE INGREDIENT	27YLU75U4W	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
SEPIA OFFICINALIS JUICE	ACTIVE INGREDIENT	QDL83WN8C2	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
SODIUM SULFATE	ACTIVE INGREDIENT	0YPR65R21J	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
ACONITUM NAPELLUS	ACTIVE MOIETY	U0NQ8555JD	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
BRYONIA ALBA ROOT	ACTIVE MOIETY	T7J046YI2B	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
CINCHONA OFFICINALIS BARK	ACTIVE MOIETY	S003A158SB	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
HOPS	ACTIVE MOIETY	01G73H6H83	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
LYCOPERDON UTRIFORME FRUITING BODY	ACTIVE MOIETY	K2A74U428F	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
MERCURY	ACTIVE MOIETY	FXS1BY2PGL	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
MORELLA CERIFERA ROOT BARK	ACTIVE MOIETY	S46HJ3710D	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
PHOSPHORUS	ACTIVE MOIETY	27YLU75U4W	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
SEPIA OFFICINALIS JUICE	ACTIVE MOIETY	QDL83WN8C2	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
SODIUM SULFATE ANHYDROUS	ACTIVE MOIETY	36KCS0R750	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57955-5114	NEWBORN TONIC (ACONITUM NAPELLUS, BOVISTA, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, LUPULINUM, MERCURIUS VIVUS, MYRICA CERIFERA, NATRUM SULPHURICUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]	1	Legacy NDC, 1 package rows	20140321_1c8b57ab-486d-4257-947b-0d114374825a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U0NQ8555JD	ACONITUM NAPELLUS		ACONITUM NAPELLUS
K2A74U428F	LYCOPERDON UTRIFORME FRUITING BODY		LYCOPERDON UTRIFORME FRUITING BODY
T7J046YI2B	BRYONIA ALBA ROOT		BRYONIA ALBA ROOT
S003A158SB	CINCHONA OFFICINALIS BARK		CINCHONA OFFICINALIS BARK
01G73H6H83	HOPS		HOPS
FXS1BY2PGL	MERCURY	7439-97-6	MERCURY
S46HJ3710D	MORELLA CERIFERA ROOT BARK		MORELLA CERIFERA ROOT BARK
0YPR65R21J	SODIUM SULFATE	7727-73-3	SODIUM SULFATE
27YLU75U4W	PHOSPHORUS	7723-14-0	PHOSPHORUS
QDL83WN8C2	SEPIA OFFICINALIS JUICE		SEPIA OFFICINALIS JUICE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
57955-5114-2	57955511402	59 mL in 1 BOTTLE, SPRAY	59 ml	Historical