Burn

Product NDC: 58301-181
11-digit product format: 583010181
Labeler code: 58301
Product ID: 58301-181_ca25ffb3-f69c-4d2c-aa94-525ef518df91
Type: HUMAN OTC DRUG
Nonproprietary name: Aesculus hippocastanum, Aloe socotrina, Arnica montana, Berberis vulgaris, Calendula officinalis, Salicylicum acidum, Zincum metallicum
Dosage form: SPRAY
Route: TOPICAL
Labeler: MBI Distributing Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2010-09-01
Marketing end: 0000-00-00
Substance: AESCULUS HIPPOCASTANUM FLOWER; ALOE; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; SALICYLIC ACID; ZINC SULFATE HEPTAHYDRATE
Active strength: 4 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL
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	58301-181		I	Inactivated by FDA		2026-10-05
excluded package	package	58301-181	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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	58301-181-28	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
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58301-181-28	2020-01-31	C162847	48780-1	9d75b9d0-5b00-f424-e053-dadaa90a57ce	9a6f173c-7dcf-4a1c-8817-486eeace753d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58301-181-28	Burn	60 mL in 1 BOTTLE, SPRAY	SPRAY	60		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AESCULUS HIPPOCASTANUM FLOWER	ACTIVE INGREDIENT	KK0Z92II8M	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
ALOE	ACTIVE INGREDIENT	V5VD430YW9	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
BERBERIS VULGARIS ROOT BARK	ACTIVE INGREDIENT	1TH8Q20J0U	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE INGREDIENT	18E7415PXQ	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
ZINC SULFATE HEPTAHYDRATE	ACTIVE INGREDIENT	N57JI2K7WP	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
AESCULUS HIPPOCASTANUM FLOWER	ACTIVE MOIETY	KK0Z92II8M	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
ALOE	ACTIVE MOIETY	V5VD430YW9	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
BERBERIS VULGARIS ROOT BARK	ACTIVE MOIETY	1TH8Q20J0U	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE MOIETY	18E7415PXQ	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
AVOCADO OIL	INACTIVE INGREDIENT	6VNO72PFC1	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58301-181	BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]	6	Legacy NDC, 1 package rows	20110802_9a6f173c-7dcf-4a1c-8817-486eeace753d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KK0Z92II8M	AESCULUS HIPPOCASTANUM FLOWER		AESCULUS HIPPOCASTANUM FLOWER
V5VD430YW9	ALOE		ALOE
O80TY208ZW	ARNICA MONTANA	8057-65-6	ARNICA MONTANA
1TH8Q20J0U	BERBERIS VULGARIS ROOT BARK		BERBERIS VULGARIS ROOT BARK
18E7415PXQ	CALENDULA OFFICINALIS FLOWERING TOP		CALENDULA OFFICINALIS FLOWERING TOP
O414PZ4LPZ	SALICYLIC ACID	69-72-7	SALICYLIC ACID
N57JI2K7WP	ZINC SULFATE HEPTAHYDRATE	7446-20-0	ZINC SULFATE HEPTAHYDRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
58301-181-28	58301018128	60 mL in 1 BOTTLE, SPRAY	60 ml	Historical