SEBOBALANCE Purifying Sebo-absorbing Mask

Product NDC: 62499-535
11-digit product format: 624990535
Labeler code: 62499
Product ID: 62499-535_6d00776f-043e-4e47-974d-a9f6fa630108
Type: HUMAN OTC DRUG
Nonproprietary name: Salicylic Acid
Dosage form: PASTE
Route: TOPICAL
Labeler: Laboratoire Dr. Renaud
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-06-29
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 1 g/100g
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	62499-535		I	Inactivated by FDA	2026-10-16
excluded package	package	62499-535	62499-535-09	I	Inactivated by FDA	2026-10-16
excluded package	package	62499-535	62499-535-11	I	Inactivated by FDA	2026-10-16

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 · 66 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	62499-535-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62499-535-11	`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	62499-535-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62499-535-11	`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	62499-535-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62499-535-11	`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	62499-535-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62499-535-11	`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	62499-535-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62499-535-11	`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	62499-535-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62499-535-11	`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	62499-535-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62499-535-11	`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	62499-535-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62499-535-11	`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	62499-535-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62499-535-11	`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	62499-535-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62499-535-11	`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	62499-535-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62499-535-11	`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	62499-535-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62499-535-11	`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	62499-535-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	62499-535-11	`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	62499-535-09	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	62499-535-11	`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	62499-535-09	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	62499-535-11	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	62499-535-11	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	62499-535-09	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	62499-535-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	62499-535-09	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	62499-535-11	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	62499-535-09	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	62499-535-11	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	62499-535-09	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	62499-535-11	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	62499-535-09	`e2bbac7714bc…`	`27bdfed8d636…`

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62499-535-09	2019-10-29	C162847	48780-1	960f7f55-c4f7-8e05-e053-dbdaa90a074a	Drug Facts
62499-535-11	2019-10-29	C162847	48780-1	960f7f55-c4f7-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62499-535-08	SEBOBALANCE Purifying Sebo-absorbing Mask	60 g in 1 TUBE	PASTE	60	3
62499-535-09	SEBOBALANCE Purifying Sebo-absorbing Mask	200 g in 1 TUBE	PASTE	200	3
62499-535-11	SEBOBALANCE Purifying Sebo-absorbing Mask	1 in 1 CARTON	PASTE	1	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
CHAMOMILE FLOWER OIL	INACTIVE INGREDIENT	60F80Z61A9	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
GALANGAL OIL	INACTIVE INGREDIENT	K0951TAR6Z	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
HECTORITE	INACTIVE INGREDIENT	08X4KI73EZ	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
LAVANDIN OIL	INACTIVE INGREDIENT	9RES347CKG	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
MASOPROCOL	INACTIVE INGREDIENT	7BO8G1BYQU	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
OLEANOLIC ACID	INACTIVE INGREDIENT	6SMK8R7TGJ	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
ROSEMARY OIL	INACTIVE INGREDIENT	8LGU7VM393	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
SAGE OIL	INACTIVE INGREDIENT	U27K0H1H2O	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62499-535	SEBOBALANCE PURIFYING SEBO-ABSORBING MASK (SALICYLIC ACID ) PASTE [LABORATOIRE DR. RENAUD]	3	Legacy NDC, 3 package rows	20101007_21b4619d-324c-4ad5-b82b-40377e4a2f1d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O414PZ4LPZ	SALICYLIC ACID	69-72-7	SALICYLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1014639	salicylic acid 1 % Paste	PSN	21b4619d-324c-4ad5-b82b-40377e4a2f1d	3
1014642	Sebobalance 1 % Topical Paste	PSN	21b4619d-324c-4ad5-b82b-40377e4a2f1d	3
1014642	salicylic acid 0.01 MG/MG Paste [Sebobalance]	SBD	21b4619d-324c-4ad5-b82b-40377e4a2f1d	3
1014639	salicylic acid 0.01 MG/MG Paste	SCD	21b4619d-324c-4ad5-b82b-40377e4a2f1d	3
1014639	salicylic acid 1 % Paste	SY	21b4619d-324c-4ad5-b82b-40377e4a2f1d	3
1014642	Sebobalance 0.01 MG/MG Paste	SY	21b4619d-324c-4ad5-b82b-40377e4a2f1d	3
1014642	Sebobalance 1 % Topical Paste	SY	21b4619d-324c-4ad5-b82b-40377e4a2f1d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
62499-535-08	62499053508	60 g in 1 TUBE	60 g	Historical
62499-535-09	62499053509	200 g in 1 TUBE	200 g	Historical
62499-535-11	62499053511	1 in 1 CARTON		Historical