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	2026-10-21
excluded package	package	49527-825	49527-825-02	D	Discontinued by firm	2026-10-21
excluded package	package	49527-825	49527-825-03	D	Discontinued by firm	2026-10-21
excluded package	package	49527-825	49527-825-04	D	Discontinued by firm	2026-10-21

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 39 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rush Salicylc Acid Complexion Pads	SALICYLIC ACID	G.S. COSMECEUTICAL USA, INC.	e9c3c3aa-e0e0-45aa-b97c-dc211e2f62b1	2024-11-26	Warnings	Exact identifier application number: M006
EVEN BETTER CLINICAL ACNE SOLUTIONS	SALICYLIC ACID	CLINIQUE LABORATORIES LLC	02e22431-ae2f-1f42-e063-6394a90aa3af	2024-11-25	Warnings	Exact identifier application number: M006
Oxy Hydrating Anti-Blemish Body Wash	OXY HYDRATING ANTI-BLEMISH BODY WASH	The Mentholatum Company	21b64a3f-2c90-1c1a-e063-6294a90a0ea0	2024-11-23	Warnings	Exact identifier application number: M006
Neutrogena Oil-Free Acne Stress Control Power-Cream Wash	SALICYLIC ACID	Kenvue Brands LLC	f1d1053e-d863-4f02-9339-843d3d3e630e	2024-11-20	Warnings	Exact identifier application number: M006
Equate Acne Wash Acne medication	BENZOYL PEROXIDE	Wal-Mart Stores, Inc.	3c108488-dfaf-447c-ba26-15fd7cf67761	2024-11-18	Warnings	Exact identifier application number: M006
ACNE solutions CLARIFYING	SALICYLIC ACID	CLINIQUE LABORATORIES LLC	dc1b2e2e-0e13-4029-bdac-44adb70492fd	2024-11-18	Warnings	Exact identifier application number: M006
Meijer Maximum Strength Foaming Acne Face Wash Acne Medication	BENZOYL PEROXIDE	Meijer Distribution, Inc	4cfbaa79-ee6c-4946-8f8c-cda71b7a80fd	2024-11-15	Warnings	Exact identifier application number: M006
amazon basics acne blackhead clearing scrub Acne Treatment	SALICYLIC ACID	AMAZON.COM SERVICES LLC	8e129137-85c6-423d-936e-4266988506a2	2024-11-15	Warnings	Exact identifier application number: M006
AGE INTERVENTION DUALITY MD	BENZOYL PEROXIDE	G.S. COSMECEUTICAL USA, INC.	6d885fe2-8a2d-44d4-84d9-932c48260f79	2024-11-15	Warnings	Exact identifier application number: M006
AGE INTERVENTION DUALITY	BENZOYL PEROXIDE	G.S. COSMECEUTICAL USA, INC.	33fb5893-ea63-49a3-bb02-6b98c747c4fe	2024-11-15	Warnings	Exact identifier application number: M006
Amazon Basics Acne Wash Acne treatment	SALICYLIC ACID	AMAZON.COM SERVICES LLC	2e41ca5f-127a-4387-a64a-c5a4ab36192a	2024-11-15	Warnings	Exact identifier application number: M006
Meijer Acne Foaming Cleanser Acne Treatment	BENZOYL PEROXIDE	Meijer Distribution, Inc	cbf0587a-29c4-47ce-bd09-2bccaddba3b7	2024-11-15	Warnings	Exact identifier application number: M006
e.l.f Plz Clarify Facial Oil	E.L.F PLZ CLARIFY FACIAL OIL	Zhejiang Ayan Biotech Co., Ltd.	25a8a0fe-d09b-3e20-e063-6394a90a51f0	2024-11-14	Warnings	Exact identifier application number: M006
amazon basics acne foaming cleanser Acne Treatment	BENZOYL PEROXIDE	AMAZON.COM SERVICES LLC	bdfbaeab-137a-49d5-bdc3-06349b8a0564	2024-11-14	Warnings	Exact identifier application number: M006
amazon basics advanced blemish spot treatment Acne medication	SALICYLIC ACID	AMAZON.COM SERVICES LLC	67c1ef50-ecae-46a5-924e-1cff19481050	2024-11-14	Warnings	Exact identifier application number: M006
Neutrogena SkinClearing Mineral Powder Chestnut 135	SALICYLIC ACID	Kenvue Brands LLC	0d1556d3-d689-c4c1-e063-6394a90adab0	2024-11-13	Warnings	Exact identifier application number: M006
Neutrogena Oil Free Acne Wash	SALICYLIC ACID	Kenvue Brands LLC	581ea73f-439a-4290-a8c0-98a25b4496dc	2024-11-12	Warnings	Exact identifier application number: M006
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial Cleanser	SALICYLIC ACID	Kenvue Brands LLC	2dde181f-d24f-4239-bec5-ded7fdbc98c4	2024-11-12	Warnings	Exact identifier application number: M006
Neutrogena deep clean purifying cooling gel scrub	SALICYLIC ACID	Kenvue Brands LLC	da2ce634-36c4-b5b7-e053-2a95a90abefb	2024-11-12	Warnings	Exact identifier application number: M006
Cetaphil Gentle Clear Mattifying Acne Moisturizer	SALICYLIC ACID	Galderma Laboratories, L.P.	72977030-d9b6-435f-b321-edcbbb731587	2024-11-12	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