COATS ALOE

Product NDC: 58826-702
11-digit product format: 588260702
Labeler code: 58826
Product ID: 58826-702_241d866f-6820-58d4-e054-00144ff8d46c
Type: HUMAN OTC DRUG
Nonproprietary name: ALLANTOIN
Dosage form: LOTION
Route: TOPICAL
Labeler: TYCHASIS CORPORATION
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-10-10
Marketing end: 0000-00-00
Substance: ALLANTOIN
Active strength: 1 g/100mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58826-702		I	Inactivated by FDA	2026-10-05
excluded package	package	58826-702	58826-702-02	I	Inactivated by FDA	2026-10-05
excluded package	package	58826-702	58826-702-08	I	Inactivated by FDA	2026-10-05
excluded package	package	58826-702	58826-702-33	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 2 · 88 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58826-702-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58826-702-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58826-702-33	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58826-702-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58826-702-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58826-702-33	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58826-702-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58826-702-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58826-702-33	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58826-702-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58826-702-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58826-702-33	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58826-702-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58826-702-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58826-702-33	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58826-702-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58826-702-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58826-702-33	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58826-702-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58826-702-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58826-702-33	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58826-702-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58826-702-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58826-702-33	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58826-702-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58826-702-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58826-702-33	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58826-702-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58826-702-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58826-702-33	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58826-702-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58826-702-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58826-702-33	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58826-702-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58826-702-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58826-702-33	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58826-702-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58826-702-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58826-702-33	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58826-702-08	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58826-702-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58826-702-33	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58826-702-08	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58826-702-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58826-702-33	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58826-702-02	2020-01-31	C162847	48780-1	9d75b9d1-036f-f424-e053-dadaa90a57ce	COATS ALOE LOTION 85%
58826-702-08	2020-01-31	C162847	48780-1	9d75b9d1-036f-f424-e053-dadaa90a57ce	COATS ALOE LOTION 85%
58826-702-33	2020-01-31	C162847	48780-1	9d75b9d1-036f-f424-e053-dadaa90a57ce	COATS ALOE LOTION 85%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58826-702-02	COATS ALOE	59 mL in 1 BOTTLE, DISPENSING	LOTION	59	4
58826-702-08	COATS ALOE	237 mL in 1 BOTTLE, DISPENSING	LOTION	237	4
58826-702-33	COATS ALOE	976 mL in 1 BOTTLE, DISPENSING	LOTION	976	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58826-702-02	ML - Milliliter	58826-702	f0690c6e-e3dd-4463-b45f-0bd1e492e407	1	2015-10-02
58826-702-08	ML - Milliliter	58826-702	754d0611-f9c9-4f13-811c-f586e5b892d2	1	2015-10-02
58826-702-33	ML - Milliliter	58826-702	b30c3b1e-8644-4081-bb53-1c520cfe3952	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLANTOIN	ACTIVE INGREDIENT	344S277G0Z	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
ALLANTOIN	ACTIVE MOIETY	344S277G0Z	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
BOROGLYCERIN	INACTIVE INGREDIENT	U3LMU4AN21	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
DIETHYLHEXYL ADIPATE	INACTIVE INGREDIENT	MBY1SL921L	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
ETHYLHEXYL STEARATE	INACTIVE INGREDIENT	EG3PA2K3K5	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
GLYCERYL STEARATE SE	INACTIVE INGREDIENT	FCZ5MH785I	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
LAURETH-23	INACTIVE INGREDIENT	N72LMW566G	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
LAURETH-4	INACTIVE INGREDIENT	6HQ855798J	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
METHYL GLUCETH-20	INACTIVE INGREDIENT	J3QD0LD11P	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58826-702	COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]	4	Legacy NDC, 3 package rows	20151109_20d386db-0d51-172f-e054-00144ff88e88.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
344S277G0Z	ALLANTOIN	97-59-6	ALLANTOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1087954	allantoin 0.5 % Topical Lotion	PSN	20d386db-0d51-172f-e054-00144ff88e88	4
1087954	allantoin 5 MG/ML Topical Lotion	SCD	20d386db-0d51-172f-e054-00144ff88e88	4
1087954	allantoin 0.5 % Topical Lotion	SY	20d386db-0d51-172f-e054-00144ff88e88	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
58826-702-02	58826070202	59 mL in 1 BOTTLE, DISPENSING	59 ml	Historical
58826-702-08	58826070208	237 mL in 1 BOTTLE, DISPENSING	237 ml	Historical
58826-702-33	58826070233	976 mL in 1 BOTTLE, DISPENSING	976 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COATS ALOE LOTION 85%	TYCHASIS CORPORATION \| BIOMED LABORATORIES	2015-11-09	HUMAN OTC DRUG LABEL	4