CLEAR UP Prep

Product NDC: 62499-395
11-digit product format: 624990395
Labeler code: 62499
Product ID: 62499-395_54210f16-ce52-4575-85c3-a5e8b9f58f52
Type: HUMAN OTC DRUG
Nonproprietary name: Salicylic Acid
Dosage form: GEL
Route: TOPICAL
Labeler: Laboratoire Dr. Renaud
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-07-01
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 2 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	62499-395		I	Inactivated by FDA		2026-10-12
excluded package	package	62499-395	62499-395-11	I	Inactivated by FDA		2026-10-12

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	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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`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	62499-395-11	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	62499-395-11	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	62499-395-11	`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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
597b1cfd-7b31-5048-62be-ca5cd740da2f	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
62499-395-11	2019-10-29	C162847	48780-1	960f7f55-c79d-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62499-395-10	CLEAR UP Prep	5 g in 1 TUBE	GEL	5		4
62499-395-11	CLEAR UP Prep	1 in 1 CARTON	GEL	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
ARCTIUM LAPPA ROOT	INACTIVE INGREDIENT	597E9BI3Z3	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
GLYCOLIC ACID	INACTIVE INGREDIENT	0WT12SX38S	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
LEMON OIL	INACTIVE INGREDIENT	I9GRO824LL	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
METHYL GLUCETH-20	INACTIVE INGREDIENT	J3QD0LD11P	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
SAGE OIL	INACTIVE INGREDIENT	U27K0H1H2O	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
SAPONARIA OFFICINALIS ROOT	INACTIVE INGREDIENT	RI2K1BMA8B	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62499-395	CLEAR UP PREP (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]	4	Legacy NDC, 2 package rows	20101020_923ffc6d-6548-4ecf-ba6b-27ec9e9accbe.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
346298	salicylic acid 2 % Topical Gel	PSN	923ffc6d-6548-4ecf-ba6b-27ec9e9accbe	4
346298	salicylic acid 0.02 MG/MG Topical Gel	SCD	923ffc6d-6548-4ecf-ba6b-27ec9e9accbe	4
346298	salicylic acid 2 % Topical Gel	SY	923ffc6d-6548-4ecf-ba6b-27ec9e9accbe	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
62499-395-10	62499039510	5 g in 1 TUBE	5 g	Historical
62499-395-11	62499039511	1 in 1 CARTON		Historical