Breakout Clearing Overnight Treatment

Product NDC: 68479-313
11-digit product format: 684790313
Labeler code: 68479
Product ID: 68479-313_1278f223-284b-4de2-a570-b7fb0394aa41
Type: HUMAN OTC DRUG
Nonproprietary name: Salicylic Acid
Dosage form: LOTION
Route: TOPICAL
Labeler: Dermalogica, Inc.
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-09-06
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 20 mg/mL
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	68479-313		I	Inactivated by FDA	2026-10-05
excluded package	package	68479-313	68479-313-00	I	Inactivated by FDA	2026-10-05
excluded package	package	68479-313	68479-313-01	I	Inactivated by FDA	2026-10-05
excluded package	package	68479-313	68479-313-02	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 · 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	68479-313-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68479-313-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68479-313-02	`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	68479-313-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68479-313-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68479-313-02	`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	68479-313-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68479-313-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68479-313-02	`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	68479-313-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68479-313-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68479-313-02	`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	68479-313-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68479-313-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68479-313-02	`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	68479-313-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68479-313-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68479-313-02	`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	68479-313-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68479-313-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68479-313-02	`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	68479-313-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68479-313-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68479-313-02	`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	68479-313-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68479-313-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68479-313-02	`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	68479-313-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68479-313-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68479-313-02	`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	68479-313-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68479-313-00	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68479-313-02	`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	68479-313-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68479-313-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68479-313-02	`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	68479-313-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68479-313-00	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68479-313-02	`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	68479-313-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68479-313-00	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68479-313-02	`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	68479-313-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68479-313-00	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68479-313-02	`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
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68479-313-00	2020-01-31	C162847	48780-1	9d75b9d0-a327-f424-e053-dadaa90a57ce	Breakout Clearing Overnight Treatment
68479-313-01	2020-01-31	C162847	48780-1	9d75b9d0-a327-f424-e053-dadaa90a57ce	Breakout Clearing Overnight Treatment
68479-313-02	2020-01-31	C162847	48780-1	9d75b9d0-a327-f424-e053-dadaa90a57ce	Breakout Clearing Overnight Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68479-313-00	Breakout Clearing Overnight Treatment	2 mL in 1 POUCH	LOTION	2	1
68479-313-01	Breakout Clearing Overnight Treatment	14 mL in 1 TUBE	LOTION	14	1
68479-313-02	Breakout Clearing Overnight Treatment	1 in 1 CARTON	LOTION	1	1
68479-313-02	Breakout Clearing Overnight Treatment	59 mL in 1 TUBE	LOTION	59	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Salicylic Acid	ACTIVE INGREDIENT	O414PZ4LPZ	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Salicylic Acid	ACTIVE MOIETY	O414PZ4LPZ	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Alkyl (C12-15) Benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Butylene Glycol	INACTIVE INGREDIENT	3XUS85K0RA	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Cetostearyl Alcohol	INACTIVE INGREDIENT	2DMT128M1S	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Cucumber	INACTIVE INGREDIENT	YY7C30VXJT	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
FILIPENDULA ULMARIA ROOT	INACTIVE INGREDIENT	997724QNDS	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Green Tea Leaf	INACTIVE INGREDIENT	W2ZU1RY8B0	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)	INACTIVE INGREDIENT	86FQE96TZ4	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Isohexadecane	INACTIVE INGREDIENT	918X1OUF1E	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Lavandula Angustifolia Flower	INACTIVE INGREDIENT	19AH1RAF4M	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Medium-Chain Triglycerides	INACTIVE INGREDIENT	C9H2L21V7U	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Polyoxyl 20 Cetostearyl Ether	INACTIVE INGREDIENT	YRC528SWUY	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Porphyra Umbilicalis	INACTIVE INGREDIENT	14AN0J70WO	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Propanediol	INACTIVE INGREDIENT	5965N8W85T	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Tea Tree Oil	INACTIVE INGREDIENT	VIF565UC2G	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1
Zinc Acetate	INACTIVE INGREDIENT	FM5526K07A	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68479-313	BREAKOUT CLEARING OVERNIGHT TREATMENT (SALICYLIC ACID) LOTION [DERMALOGICA, INC.]	1	Legacy NDC, 4 package rows	20140213_b8af71fd-ecf3-4bb1-9b57-e11dfe703b6c.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68479-313-00	68479031300	2 mL in 1 POUCH	2 ml	Historical
68479-313-01	68479031301	14 mL in 1 TUBE	14 ml	Historical
68479-313-02	68479031302	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Breakout Clearing Overnight Treatment	Dermalogica, Inc. \| Cosway \| Diamond Wipes	2014-02-05	HUMAN OTC DRUG LABEL	1