ClearPrep FX

Product NDC: 68327-006
11-digit product format: 683270006
Labeler code: 68327
Product ID: 68327-006_05ed1245-f8fd-45d1-85ad-5dad98bf568e
Type: HUMAN OTC DRUG
Nonproprietary name: SALICYLIC ACID
Dosage form: GEL
Route: TOPICAL
Labeler: Cover FX Skin Care, Inc.
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-07-01
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 1 g/100mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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	68327-006		I	Inactivated by FDA	2026-10-20
excluded package	package	68327-006	68327-006-01	I	Inactivated by FDA	2026-10-20
excluded package	package	68327-006	68327-006-02	I	Inactivated by FDA	2026-10-20
excluded package	package	68327-006	68327-006-03	I	Inactivated by FDA	2026-10-20

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 · 84 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	68327-006-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68327-006-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68327-006-01	`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	68327-006-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68327-006-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68327-006-01	`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	68327-006-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68327-006-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68327-006-01	`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	68327-006-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68327-006-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68327-006-01	`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	68327-006-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68327-006-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68327-006-01	`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	68327-006-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68327-006-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68327-006-01	`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	68327-006-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68327-006-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68327-006-01	`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	68327-006-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68327-006-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68327-006-01	`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	68327-006-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68327-006-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68327-006-01	`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	68327-006-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68327-006-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68327-006-01	`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	68327-006-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68327-006-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68327-006-01	`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	68327-006-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68327-006-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68327-006-01	`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	68327-006-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68327-006-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68327-006-01	`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	68327-006-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68327-006-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68327-006-01	`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	68327-006-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68327-006-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68327-006-01	`1332a3947898…`	`d4bfe170f9cd…`

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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68327-006-01	2020-01-31	C162847	48780-1	9d75b9d0-b401-f424-e053-dadaa90a57ce	5889aae9-6224-4cb1-a184-67a76597a48c
68327-006-02	2020-01-31	C162847	48780-1	9d75b9d0-b401-f424-e053-dadaa90a57ce	5889aae9-6224-4cb1-a184-67a76597a48c
68327-006-03	2020-01-31	C162847	48780-1	9d75b9d0-b401-f424-e053-dadaa90a57ce	5889aae9-6224-4cb1-a184-67a76597a48c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68327-006-01	ClearPrep FX	30 mL in 1 TUBE	GEL	30	1
68327-006-02	ClearPrep FX	15 mL in 1 TUBE	GEL	15	1
68327-006-03	ClearPrep FX	7 mL in 1 TUBE	GEL	7	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
ACER SACCHARUM BARK/SAP	INACTIVE INGREDIENT	Z120VL0KAC	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
ANNICKIA CHLORANTHA BARK	INACTIVE INGREDIENT	H70115MP4A	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
BILBERRY	INACTIVE INGREDIENT	9P2U39H18W	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
CASEIN	INACTIVE INGREDIENT	48268V50D5	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)	INACTIVE INGREDIENT	035JKJ76MT	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
CITRUS AURANTIUM FLOWER OIL	INACTIVE INGREDIENT	D4BGE91OXH	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER	INACTIVE INGREDIENT	RSA9I561OK	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)	INACTIVE INGREDIENT	9E4CO0W6C5	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
DIMETHICONOL (40 CST)	INACTIVE INGREDIENT	343C7U75XW	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
LEMON	INACTIVE INGREDIENT	24RS0A988O	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
LINOLEIC ACID	INACTIVE INGREDIENT	9KJL21T0QJ	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
LINOLENIC ACID	INACTIVE INGREDIENT	0RBV727H71	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
MASOPROCOL	INACTIVE INGREDIENT	7BO8G1BYQU	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
OLEANOLIC ACID	INACTIVE INGREDIENT	6SMK8R7TGJ	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
ORANGE	INACTIVE INGREDIENT	5EVU04N5QU	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
PALMITOYL OLIGOPEPTIDE	INACTIVE INGREDIENT	HO4ZT5S86C	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
PALMITOYL TETRAPEPTIDE-7	INACTIVE INGREDIENT	Q41S464P1R	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
PEG-60 ALMOND GLYCERIDES	INACTIVE INGREDIENT	4Y0E651N0F	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)	INACTIVE INGREDIENT	59Z907ZB69	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
SALIX NIGRA BARK	INACTIVE INGREDIENT	QU52J3A5B3	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
SUGARCANE	INACTIVE INGREDIENT	81H2R5AOH3	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
TETRAHEXYLDECYL ASCORBATE	INACTIVE INGREDIENT	9LBV3F07AZ	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68327-006	CLEARPREP FX (SALICYLIC ACID) GEL [COVER FX SKIN CARE, INC.]	1	Legacy NDC, 3 package rows	20130220_5889aae9-6224-4cb1-a184-67a76597a48c.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
251380	salicylic acid 1 % Topical Gel	PSN	5889aae9-6224-4cb1-a184-67a76597a48c	1
251380	salicylic acid 0.01 MG/MG Topical Gel	SCD	5889aae9-6224-4cb1-a184-67a76597a48c	1
251380	salicylic acid 1 % Topical Gel	SY	5889aae9-6224-4cb1-a184-67a76597a48c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68327-006-01	68327000601	30 mL in 1 TUBE	30 ml	Historical
68327-006-02	68327000602	15 mL in 1 TUBE	15 ml	Historical
68327-006-03	68327000603	7 mL in 1 TUBE	7 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ClearPrep FX - Cover FX Skin Care, Inc.	Cover FX Skin Care, Inc.	2013-02-19	HUMAN OTC DRUG LABEL	1