Gout Symptom Relief

Product NDC: 57955-0021
11-digit product format: 579550021
Labeler code: 57955
Product ID: 57955-0021_feebffed-535b-43dc-b78d-cb4bd5294350
Type: HUMAN OTC DRUG
Nonproprietary name: Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens
Dosage form: LIQUID
Route: ORAL
Labeler: King Bio Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2012-11-06
Marketing end: 0000-00-00
Substance: AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR BARK; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS
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	57955-0021		I	Inactivated by FDA		2026-08-11
excluded package	package	57955-0021	57955-0021-2	I	Inactivated by FDA		2026-08-11

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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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	57955-0021-2	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
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57955-0021-2	2020-01-31	C162847	48780-1	9d75b9d0-1c87-f424-e053-dadaa90a57ce	Gout Symptom Relief™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57955-0021-2	Gout Symptom Relief	59 mL in 1 BOTTLE, SPRAY	LIQUID	59		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMMONIUM PHOSPHATE, DIBASIC	ACTIVE INGREDIENT	10LGE70FSU	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
COLCHICUM AUTUMNALE BULB	ACTIVE INGREDIENT	993QHL78E6	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
FORMIC ACID	ACTIVE INGREDIENT	0YIW783RG1	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
FRAXINUS EXCELSIOR BARK	ACTIVE INGREDIENT	R6KCX5H8I2	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
FRAXINUS EXCELSIOR LEAF	ACTIVE INGREDIENT	RC38362Q7M	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
LEDUM PALUSTRE TWIG	ACTIVE INGREDIENT	877L01IZ0P	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
SODIUM CARBONATE	ACTIVE INGREDIENT	45P3261C7T	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE INGREDIENT	269XH13919	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
URTICA URENS	ACTIVE INGREDIENT	IHN2NQ5OF9	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
CARBONATE ION	ACTIVE MOIETY	7UJQ5OPE7D	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
COLCHICUM AUTUMNALE BULB	ACTIVE MOIETY	993QHL78E6	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
FORMIC ACID	ACTIVE MOIETY	0YIW783RG1	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
FRAXINUS EXCELSIOR BARK	ACTIVE MOIETY	R6KCX5H8I2	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
FRAXINUS EXCELSIOR LEAF	ACTIVE MOIETY	RC38362Q7M	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
LEDUM PALUSTRE TWIG	ACTIVE MOIETY	877L01IZ0P	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
PHOSPHATE ION	ACTIVE MOIETY	NK08V8K8HR	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE MOIETY	269XH13919	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
URTICA URENS	ACTIVE MOIETY	IHN2NQ5OF9	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57955-0021	GOUT SYMPTOM RELIEF (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS) LIQUID [KING BIO INC.]	1	Legacy NDC, 1 package rows	20150310_6f7e17d1-cb7e-4be5-9690-f755f3f7fde2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
10LGE70FSU	AMMONIUM PHOSPHATE, DIBASIC	7783-28-0	AMMONIUM PHOSPHATE, DIBASIC
WQZ3G9PF0H	ATROPA BELLADONNA		ATROPA BELLADONNA
993QHL78E6	COLCHICUM AUTUMNALE BULB		COLCHICUM AUTUMNALE BULB
0YIW783RG1	FORMIC ACID	64-18-6	FORMIC ACID
R6KCX5H8I2	FRAXINUS EXCELSIOR BARK		FRAXINUS EXCELSIOR BARK
RC38362Q7M	FRAXINUS EXCELSIOR LEAF		FRAXINUS EXCELSIOR LEAF
45P3261C7T	SODIUM CARBONATE	497-19-8	SODIUM CARBONATE
269XH13919	STRYCHNOS NUX-VOMICA SEED	8046-97-7	STRYCHNOS NUX-VOMICA SEED
IHN2NQ5OF9	URTICA URENS		URTICA URENS

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
57955-0021-2	57955002102	59 mL in 1 BOTTLE, SPRAY	59 ml	Historical