Headache

Product NDC: 57520-0305
11-digit product format: 575200305
Labeler code: 57520
Product ID: 57520-0305_f98d055a-1902-4137-ba2b-2300a0385996
Type: HUMAN OTC DRUG
Nonproprietary name: Belladonna, Bryonia, Gelsemium sempervirens, Glonionum, Melilotus officinalis, Natrum muriaticum, Nitricum acidum, Nux vomica, Silicea Spigelia anthelmia
Dosage form: LIQUID
Route: ORAL
Labeler: Apotheca Company
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2010-04-12
Marketing end: 2022-09-10
Substance: ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; MELILOTUS OFFICINALIS POLLEN; NITRIC ACID; NITROGLYCERIN; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA; STRYCHNOS NUX-VOMICA SEED
Active strength: 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes: Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Pollen [CS], Seed Storage Proteins [CS], Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	57520-0305		D	Discontinued by firm		2026-08-03
excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 32 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	57520-0305		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	57520-0305		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	57520-0305		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	57520-0305		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	57520-0305		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	57520-0305		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	57520-0305		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	57520-0305		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	57520-0305		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	57520-0305		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	57520-0305		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57520-0305	57520-0305-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	57520-0305		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57520-0305	57520-0305-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	57520-0305		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57520-0305	57520-0305-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	57520-0305		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57520-0305	57520-0305-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	57520-0305		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	57520-0305	57520-0305-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	57520-0305		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	57520-0305	57520-0305-1	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57520-0305-1	2022-04-04	C162847	48780-1	9d75b9d1-0cb1-f424-e053-dadaa90a57ce	Headache HP
57520-0305-1	2020-01-31	C162847	48780-1	9d75b9d1-0cb1-f424-e053-dadaa90a57ce	Headache HP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
BRYONIA ALBA ROOT	ACTIVE INGREDIENT	T7J046YI2B	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE INGREDIENT	639KR60Q1Q	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
MELILOTUS OFFICINALIS POLLEN	ACTIVE INGREDIENT	UVC3Z60VTX	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
NITRIC ACID	ACTIVE INGREDIENT	411VRN1TV4	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
NITROGLYCERIN	ACTIVE INGREDIENT	G59M7S0WS3	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
SILICON DIOXIDE	ACTIVE INGREDIENT	ETJ7Z6XBU4	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
SPIGELIA	ACTIVE INGREDIENT	467D26HS0B	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE INGREDIENT	269XH13919	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
BRYONIA ALBA ROOT	ACTIVE MOIETY	T7J046YI2B	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE MOIETY	639KR60Q1Q	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
MELILOTUS OFFICINALIS POLLEN	ACTIVE MOIETY	UVC3Z60VTX	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
NITRIC ACID	ACTIVE MOIETY	411VRN1TV4	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
NITROGLYCERIN	ACTIVE MOIETY	G59M7S0WS3	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
SILICON DIOXIDE	ACTIVE MOIETY	ETJ7Z6XBU4	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
SPIGELIA	ACTIVE MOIETY	467D26HS0B	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE MOIETY	269XH13919	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WQZ3G9PF0H	ATROPA BELLADONNA		ATROPA BELLADONNA
T7J046YI2B	BRYONIA ALBA ROOT		BRYONIA ALBA ROOT
639KR60Q1Q	GELSEMIUM SEMPERVIRENS ROOT		GELSEMIUM SEMPERVIRENS ROOT
UVC3Z60VTX	MELILOTUS OFFICINALIS POLLEN		MELILOTUS OFFICINALIS POLLEN
411VRN1TV4	NITRIC ACID	7697-37-2	NITRIC ACID
G59M7S0WS3	NITROGLYCERIN	55-63-0	NITROGLYCERIN
ETJ7Z6XBU4	SILICON DIOXIDE	7631-86-9	SILICON DIOXIDE
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE
269XH13919	STRYCHNOS NUX-VOMICA SEED	8046-97-7	STRYCHNOS NUX-VOMICA SEED

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57520-0305-1	57520030501	30 mL in 1 BOTTLE, DROPPER (57520-0305-1)	30 ml	2010-04-12	2022-09-10	No	No	Current

Headache

NDC auxiliary status#

Observed NDC auxiliary status history#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#