ACNE SOLUTIONS

Product NDC: 49527-825
11-digit product format: 495270825
Labeler code: 49527
Product ID: 49527-825_4bbc494e-e1c7-7800-e063-6294a90a9f64
Type: HUMAN OTC DRUG
Nonproprietary name: SALICYLIC ACID
Dosage form: GEL
Route: TOPICAL
Labeler: CLINIQUE LABORATORIES LLC
Application: M006
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-12-01
Marketing end: 2027-04-19
Substance: SALICYLIC ACID
Active strength: 10 mg/mL
NDC exclude flag: No
Current FDA listing: Yes

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 package	package	49527-825	49527-825-01	D	Discontinued by firm	2026-10-15
excluded package	package	49527-825	49527-825-02	D	Discontinued by firm	2026-10-15
excluded package	package	49527-825	49527-825-03	D	Discontinued by firm	2026-10-15
excluded package	package	49527-825	49527-825-04	D	Discontinued by firm	2026-10-15

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	49527-825-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49527-825-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49527-825-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49527-825-03	`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	49527-825-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49527-825-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49527-825-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49527-825-03	`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	49527-825-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49527-825-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49527-825-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49527-825-03	`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	49527-825-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49527-825-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49527-825-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49527-825-03	`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	49527-825-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49527-825-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49527-825-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49527-825-03	`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	49527-825-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49527-825-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49527-825-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49527-825-03	`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	49527-825-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49527-825-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49527-825-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49527-825-03	`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	49527-825-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49527-825-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49527-825-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49527-825-03	`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	49527-825-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49527-825-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49527-825-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49527-825-03	`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	49527-825-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49527-825-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49527-825-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49527-825-03	`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	49527-825-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49527-825-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49527-825-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49527-825-03	`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	49527-825-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49527-825-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49527-825-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49527-825-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: ACNE SOLUTIONS
Brand name suffix: SPOT HEALING ACNE MEDICATION

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SALICYLIC ACID	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O414PZ4LPZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
251380	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c09ee4f6-b8f9-4d20-982a-fb490830bd34	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49527-825-01	2021-04-13	C162847	48780-1	9d75b9d0-dac8-f424-e053-dadaa90a57ce	ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION
49527-825-01	2020-01-31	C162847	48780-1	9d75b9d0-dac8-f424-e053-dadaa90a57ce	ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49527-825-01	ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION	15 mL in 1 TUBE	GEL	15	11
49527-825-01	ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION	1 in 1 CARTON	GEL	1	11
49527-825-02	ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION	1 in 1 CARTON	GEL	1	11
49527-825-02	ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION	30 mL in 1 BOTTLE	GEL	30	11
49527-825-03	ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION	1 in 1 CARTON	GEL	1	11
49527-825-03	ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION	3 mL in 1 TUBE	GEL	3	11
49527-825-04	ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION	1.5 mL in 1 PACKET	GEL	1.5	11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]	2
PSEUDOPTEROGORGIA ELISABETHAE	INACTIVE INGREDIENT	UDY3H1OUX5	ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]	2
WITCH HAZEL	INACTIVE INGREDIENT	101I4J0U34	ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]	2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BLEMISH DOTS - CHARCOAL (10 PATCHES)	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	ea66728a-bfb8-4313-b308-fa54306859f7	2026-05-22	Warnings	Exact identifier application number: M006
BLEMISH DOTS - RETINOL (10 PATCHES)	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	51024d71-07ab-49d5-8c60-058388a5df0e	2026-05-22	Warnings	Exact identifier application number: M006
EVEN KEEL RESURFACING PEEL	SALICYLIC ACID	Personal Day Inc.	330dd564-ebac-46f0-8c2a-34bbf60887d1	2026-05-20	Warnings	Exact identifier application number: M006
DAILY SELF DISCOVERY SET	SALICYLIC ACID	Personal Day Inc.	93c7a610-8282-49a9-9128-0f92a92abaa7	2026-05-20	Warnings	Exact identifier application number: M006
DOING THE WORK SALICYLIC ACID ACNE TREATMENT	SALICYLIC ACID	Personal Day Inc.	4193a9ab-686a-494e-ade7-6e900e47e5b6	2026-05-20	Warnings	Exact identifier application number: M006
CeraVe Developed with Dermatologists BHA Exfoliating Toner Acne Treatment	SALICYLIC ACID	L'Oreal USA Products Inc	434ab915-faa3-40a7-8f8d-ff0eeef95e1f	2026-05-19	Warnings	Exact identifier application number: M006
Clean and Clear Essentials Dual Action Moisturizer	SALICYLIC ACID	Kenvue Brands LLC	0a3c7897-c6c8-adb6-e063-6294a90aed48	2026-05-14	Warnings	Exact identifier application number: M006
Neutrogena Oil Free Acne Wash	SALICYLIC ACID	Kenvue Brands LLC	e3d5538a-51be-0ebe-e053-2995a90a6d15	2026-05-14	Warnings	Exact identifier application number: M006
Neutrogena Oil Free Acne Moisturizer Pink Grapefruit	SALICYLIC ACID	Kenvue Brands LLC	0eda5e12-297f-4049-90f6-540f5a1d1791	2026-05-14	Warnings	Exact identifier application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Toner	SALICYLIC ACID	L'Oreal USA Products Inc	a2dc3cf4-23d2-4cb7-8fdc-615420db5710	2026-05-14	Warnings	Exact identifier application number: M006
Clearasil Rapid Rescue Spot Treatment	BENZOYL PEROXIDE	Reckitt Benckiser LLC	cae9204d-4b6f-4fc7-9857-3050ffd6d2fa	2026-05-13	Warnings	Exact identifier application number: M006
Clearasil Rapid Rescue Deep Treatment Pads	SALICYLIC ACID	Reckitt Benckiser LLC	2387e74a-312c-44bf-bda5-fc4ec1ce6208	2026-05-13	Warnings	Exact identifier application number: M006
Clearasil Rapid Rescue Deep Treatment Wash	SALICYLIC ACID	Reckitt Benckiser LLC	1745fb36-5394-46cd-bc49-d5fe32b74e21	2026-05-13	Warnings	Exact identifier application number: M006
Clearasil Stubborn Acne Control 5in1 Daily Pads	SALICYLIC ACID	Reckitt Benckiser LLC	17875670-ca6a-4dc3-97c2-c8d1f85d4d55	2026-05-13	Warnings	Exact identifier application number: M006
Clearasil Stubborn Acne Control 5in1 Exfoliating Wash	SALICYLIC ACID	Reckitt Benckiser LLC	39eb1104-e3f4-4c25-9686-dcfb6456393e	2026-05-13	Warnings	Exact identifier application number: M006
Clearasil Stubborn Acne Control 5in1 Spot Treatment	BENZOYL PEROXIDE	Reckitt Benckiser LLC	bdb87e60-67a6-4c0e-b0ab-3e238a08269c	2026-05-13	Warnings	Exact identifier application number: M006
Lixuhya MILIA REMOVER ESSENCE	SALICYLIC ACID 1% MILIA REMOVER ESSENCE	Jiangxi Yudexi Pharmaceutical Co., LTD	51872c01-804c-a29f-e063-6294a90ae546	2026-05-13	Warnings	Exact identifier application number: M006
Equate	SALICYLIC ACID	Walmart INC	2643feb4-7a29-ef9f-e063-6394a90aec8a	2026-05-08	Warnings	Exact identifier application number: M006
Neutrogena Oil-Free Acne Wash Pink Grapefruit Foaming Scrub	SALICYLIC ACID	Kenvue Brands LLC	51352d8d-f84e-20dc-e063-6294a90a20d5	2026-05-07	Warnings	Exact identifier application number: M006
Medicated Apricot Scrub	SALICYLIC ACID	Publix Super Markets, Inc.	8861e0f0-f5ef-48d2-bd63-0cf0fe6a9112	2026-05-06	Warnings, Adverse reactions	Exact identifier application number: M006

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	c09ee4f6-b8f9-4d20-982a-fb490830bd34	11
251380	salicylic acid 0.01 MG/MG Topical Gel	SCD	c09ee4f6-b8f9-4d20-982a-fb490830bd34	11
251380	salicylic acid 1 % Topical Gel	SY	c09ee4f6-b8f9-4d20-982a-fb490830bd34	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49527-825-01	49527082501	1 TUBE in 1 CARTON (49527-825-01) > 15 mL in 1 TUBE	1 tube	2022-04-28	0000-00-00	No	No	Current
49527-825-02	49527082502	1 BOTTLE in 1 CARTON (49527-825-02) > 30 mL in 1 BOTTLE	1 bottle	2022-04-28	0000-00-00	No	No	Current
49527-825-03	49527082503	1 TUBE in 1 CARTON (49527-825-03) > 3 mL in 1 TUBE	1 tube	2022-04-28	0000-00-00	No	No	Current
49527-825-04	49527082504	1.5 mL in 1 PACKET (49527-825-04)	1.5 ml	2022-06-02	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION	CLINIQUE LABORATORIES LLC \| Estee Lauder Companies Inc. \| PALC \| Estee Lauder Cosmetics Ltd. \| Whitman Laboratories Ltd. \| Estee Lauder N.V. \| The Estee Lauder Inc \| Northtec LLC \| PADC 1	2026-02-26	HUMAN OTC DRUG LABEL	11