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 28 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neutrogena Stubborn Body Acne Cleanser and Exfoliator	SALICYLIC ACID	Kenvue Brands LLC	dd13b492-5c82-a7d0-e053-2a95a90a62b3	2025-05-26	Warnings	Exact identifier application number: M006
Neutrogena Stubborn Texture Daily Cleanser	SALICYLIC ACID	Kenvue Brands LLC	ef2d9cd5-5c6c-4839-af5d-6bc21187b132	2025-05-26	Warnings	Exact identifier application number: M006
NAELI Exfoliator AHA-BHA Face Cleanser	SALICYLIC ACID	ALLI LLC	16bf50c6-4a9d-4242-94a2-d2165b82e7ce	2025-05-22	Warnings	Exact identifier application number: M006
First Aid Beauty Acne Clearing Pads	SALICYLIC ACID	The Procter & Gamble Manufacturing Company	35bd600b-5da6-5225-e063-6294a90ac6f3	2025-05-22	Warnings	Exact identifier application number: M006
First Aid Beauty Body Acne Clearing Mist	SALICYLIC ACID	The Procter & Gamble Manufacturing Company	35be1450-01c1-1668-e063-6394a90af9b5	2025-05-22	Warnings	Exact identifier application number: M006
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial Cleanser	SALICYLIC ACID	Kenvue Brands LLC	353ed0a4-dcae-7748-e063-6294a90ac3f7	2025-05-16	Warnings	Exact identifier application number: M006
Dickinsons Original Witch Hazel Exfoliating Bubble Toner	SALICYLIC ACID	Dickinson Brands Inc.	5a5119a2-d6ca-4932-9df6-faed97e1d2a1	2025-05-16	Warnings	Exact identifier application number: M006
Earths Care Acne Spot Treatment	SULFUR	DLC Laboratories, Inc.	85dab75e-5436-4e31-9ce2-c1995fde1dd9	2025-05-15	Warnings	Exact identifier application number: M006
Neutrogena On-the-Spot Acne Treatment Vanishing Formula	BENZOYL PEROXIDE	Kenvue Brands LLC	7cc8f53d-b8e3-4711-a1d3-fd43be35af51	2025-05-12	Warnings	Exact identifier application number: M006
Biome-Balancing Clear and Prevent Acne (Blemish) Treatment Serum	SALICYLIC ACID	Murad, LLC	3709208a-5550-4819-b923-a883878737bb	2025-05-05	Warnings	Exact identifier application number: M006
MY BEAUTY SPOT Day and Night Acne Patch	SALICYLIC ACID	MELON BIO-TECH (THAILAND) CO., LTD.	6e4ab3d3-378e-40e5-a6a5-66090edcfda8	2025-04-28	Warnings	Exact identifier application number: M006
Byoma Acne Control Body	SALICYLIC ACID	Byoma Ltd	2ffedd29-b05d-485c-e063-6294a90a382b	2025-04-23	Warnings	Exact identifier application number: M006
Byoma Acne Control Moisturizer	SALICYLIC ACID	Byoma Ltd	300266fa-81fb-c26a-e063-6394a90abedf	2025-04-23	Warnings	Exact identifier application number: M006
Byoma Acne Treatment Spot	SALICYLIC ACID	Byoma Ltd	301673da-7202-49cf-e063-6294a90a520e	2025-04-23	Warnings	Exact identifier application number: M006
Byoma Acne Clearing Cleanser	SALICYLIC ACID	Byoma Ltd	30036070-f5f1-c082-e063-6294a90a66e1	2025-04-23	Warnings	Exact identifier application number: M006
Neutrogena Body Clear Body Wash	SALICYLIC ACID	Kenvue Brands LLC	0d0cfe85-93ee-4815-a5c0-5995372227cc	2025-04-18	Warnings	Exact identifier application number: M006
Dickinsons Original Witch Hazel Clarifying Foam Cleanser	SALICYLIC ACID	Dickinson Brands Inc.	63f30249-2a1f-403c-9bb3-8c0c4c9dde43	2025-04-10	Warnings	Exact identifier application number: M006
Aveeno Positively Radiant Clear Complexion Daily Moisturizer	SALICYLIC ACID	Kenvue Brands LLC	3269c17c-7e3a-734c-e063-6294a90a1543	2025-04-10	Warnings	Exact identifier application number: M006
Neutrogena Clear Pore Oil-Eliminating Astringent	SALICYLIC ACID	Kenvue Brands LLC	107ad1a9-0da7-4002-a40d-cee3764c6f6b	2025-04-09	Warnings	Exact identifier application number: M006
CLARIFYING TONER	SALICYLIC ACID	Drmtlgy, LLC	cb94cf95-8954-43b4-84c9-9b1076949c99	2025-04-09	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