SBS 40

Product NDC: 11084-040
11-digit product format: 110840040
Labeler code: 11084
Product ID: 11084-040_a6650b96-9a5e-43e6-8bd4-a8d6d4c74815
Type: HUMAN OTC DRUG
Nonproprietary name: Allantoin
Dosage form: LOTION
Route: TOPICAL
Labeler: Deb USA, Inc.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-01-01
Marketing end: 0000-00-00
Substance: ALLANTOIN
Active strength: 1 mL/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	11084-040		I	Inactivated by FDA	2026-08-17
excluded package	package	11084-040	11084-040-08	I	Inactivated by FDA	2026-08-17
excluded package	package	11084-040	11084-040-35	I	Inactivated by FDA	2026-08-17
excluded package	package	11084-040	11084-040-39	I	Inactivated by FDA	2026-08-17

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	11084-040-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11084-040-35	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11084-040-39	`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	11084-040-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11084-040-35	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11084-040-39	`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	11084-040-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11084-040-35	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11084-040-39	`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	11084-040-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11084-040-35	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11084-040-39	`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	11084-040-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11084-040-35	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11084-040-39	`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	11084-040-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11084-040-35	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11084-040-39	`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	11084-040-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11084-040-35	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11084-040-39	`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	11084-040-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11084-040-35	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11084-040-39	`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	11084-040-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11084-040-35	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11084-040-39	`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	11084-040-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11084-040-35	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11084-040-39	`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	11084-040-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11084-040-35	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11084-040-39	`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	11084-040-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11084-040-35	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11084-040-39	`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	11084-040-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11084-040-35	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11084-040-39	`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	11084-040-08	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11084-040-35	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11084-040-39	`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	11084-040-08	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11084-040-35	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11084-040-39	`1332a3947898…`	`d4bfe170f9cd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11084-040-08	2019-10-21	C162847	48780-1	956f9ecf-c183-621f-e053-dbdaa90a74ad	Drug Facts
11084-040-35	2019-10-21	C162847	48780-1	956f9ecf-c183-621f-e053-dbdaa90a74ad	Drug Facts
11084-040-39	2019-10-21	C162847	48780-1	956f9ecf-c183-621f-e053-dbdaa90a74ad	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11084-040-08	SBS 40	2500 mL in 1 BOTTLE, PLASTIC	LOTION	2500	1
11084-040-35	SBS 40	148 mL in 1 TUBE	LOTION	148	1
11084-040-39	SBS 40	30 mL in 1 TUBE	LOTION	30	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Allantoin	ACTIVE INGREDIENT	344S277G0Z	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Allantoin	ACTIVE MOIETY	344S277G0Z	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Carbomer 934	INACTIVE INGREDIENT	Z135WT9208	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Cetyl Esters Wax	INACTIVE INGREDIENT	D072FFP9GU	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Chloroxylenol	INACTIVE INGREDIENT	0F32U78V2Q	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Isopropyl Palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
MAGNESIUM CHLORIDE	INACTIVE INGREDIENT	02F3473H9O	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
MAGNESIUM NITRATE	INACTIVE INGREDIENT	77CBG3UN78	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11084-040	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1	Legacy NDC, 3 package rows	20100908_52b86b15-5df4-4042-ac2b-b96fbd3db0a7.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	52b86b15-5df4-4042-ac2b-b96fbd3db0a7	1
1087954	allantoin 5 MG/ML Topical Lotion	SCD	52b86b15-5df4-4042-ac2b-b96fbd3db0a7	1
1087954	allantoin 0.5 % Topical Lotion	SY	52b86b15-5df4-4042-ac2b-b96fbd3db0a7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
11084-040-08	11084004008	2500 mL in 1 BOTTLE, PLASTIC	2500 ml	Historical
11084-040-35	11084004035	148 mL in 1 TUBE	148 ml	Historical
11084-040-39	11084004039	30 mL in 1 TUBE	30 ml	Historical