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	2026-10-20
excluded package	package	49527-825	49527-825-02	D	Discontinued by firm	2026-10-20
excluded package	package	49527-825	49527-825-03	D	Discontinued by firm	2026-10-20
excluded package	package	49527-825	49527-825-04	D	Discontinued by firm	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 · 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 34 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION Caramel	SALICYLIC ACID	ALMAY	2a982e0e-4720-797e-e063-6294a90a43c1	2024-12-31	Warnings	Exact identifier application number: M006
ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION Mocha	SALICYLIC ACID	ALMAY	2a9807d1-cf87-7096-e063-6394a90afca3	2024-12-31	Warnings	Exact identifier application number: M006
ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION Natural Tan	SALICYLIC ACID	ALMAY	2a981e22-d7d1-311b-e063-6294a90ab25f	2024-12-31	Warnings	Exact identifier application number: M006
ALMAY CLEAR COMPLEXION CONCEALER	SALICYLIC ACID	ALMAY	c3b57024-120e-390f-e053-2a95a90a6d35	2024-12-30	Warnings	Exact identifier application number: M006
Almay Clear Complexion Makeup Buff	SALICYLIC ACID	Almay	2a83300a-15f0-365a-e063-6394a90a28d1	2024-12-30	Warnings	Exact identifier application number: M006
RETINOL CLEARING	SALICYLIC ACID	Dermalogica, LLC.	4c20d87c-f3cf-4a40-acec-b0a8bfb9b29c	2024-12-30	Warnings	Exact identifier application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Balm	SALICYLIC ACID	L'Oreal USA Products Inc	0c902cfa-d98a-42c3-967b-5a7c51a65249	2024-12-30	Warnings	Exact identifier application number: M006
Salicylic Acid Cleanser	EXFOLIATING AND CLARIFYING FACE WASH	Bentley Laboratories, LLC	eb7fa2b5-3bdb-436c-8576-1eea29b8d1ff	2024-12-27	Warnings	Exact identifier application number: M006
Acne Control Superclean Body Wash AHA BHA Formula	SALICYLIC ACID	Bentley Laboratories, LLC	16fd3343-d044-4f6b-af1a-30bc32ce2041	2024-12-27	Warnings	Exact identifier application number: M006
SkinCeuticals Blemish Plus Age Defense Acne Treatment	SALICYLIC ACID	L'Oreal USA Products Inc	5726d12c-708c-46e6-a584-9e5c7a544fc8	2024-12-27	Warnings	Exact identifier application number: M006
SkinCeuticals Clarifying Exfoliating Cleanser	SALICYLIC ACID	L'Oreal USA Products Inc	a0cc4ae7-c266-4321-92e6-a46d560a74b2	2024-12-27	Warnings	Exact identifier application number: M006
BRODA Acne	SALICYLIC ACID	Bentley Laboratories, LLC	b7e1f105-8998-46a5-b1ae-85d21790b816	2024-12-27	Warnings	Exact identifier application number: M006
Monat Be Clarified Acne-Clearing Moisturizer	SALICYLIC ACID	Cosmax Usa, Corporation	2984d615-7ed1-46c3-e063-6294a90a1f8a	2024-12-26	Warnings	Exact identifier application number: M006
Nativae Milia Acne Serum	SALICYLIC ACID	CDE BRANDS LLC	e04cf0a2-bda7-4e5b-9771-769995cf6925	2024-12-26	Warnings	Exact identifier application number: M006
Milani Erase Base Blemish Control Primer	SALICYLIC ACID	Cosmax Usa, Corporation	1b1f1948-2ad9-48d2-9871-6830b2442f43	2024-12-26	Warnings	Exact identifier application number: M006
Oxy Sensitive Skin Acne Cleansing Pads	SALICYLIC ACID 0.5%	The Mentholatum Company	2a36b6c5-f518-66f0-e063-6394a90acd40	2024-12-26	Warnings	Exact identifier application number: M006
Oxy Deep Pore Acne Cleansing Pads	SALICYLIC ACID 2%	The Mentholatum Company	2a385fac-399b-c111-e063-6394a90aefc3	2024-12-26	Warnings	Exact identifier application number: M006
Oxy 3-IN-1 Acne Cleansing Pads	SALICYLIC ACID 2%	The Mentholatum Company	2a398c8d-09e6-513b-e063-6294a90ad857	2024-12-26	Warnings	Exact identifier application number: M006
DEEP ACNE	SULFUR	Dermalogica, LLC.	d4e9d230-2ee4-4cc7-a7c9-a7dde50b6f40	2024-12-26	Warnings	Exact identifier application number: M006
SUNDAY RILEY SATURN SULFUR ACNE SPOT TREATMENT MASK	SULFUR	Sunday Riley Modern Skincare, LLC	35364a71-b011-42f5-9941-4a2f8440808b	2024-12-26	Warnings	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