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 51 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Differin Acne Clearing Body	SALICYLIC ACID	Galderma Laboratories, L.P.	ce4d1074-5f74-4ad7-9535-2737f5fff24f	2023-12-11	Warnings	Exact identifier application number: M006
Vichy Laboratoires Normaderm Phytoaction Acne Control Daily Moisturizer	SALICYLIC ACID	L'Oreal USA Products Inc	b7d0d094-6a5b-4776-9f13-1f8d30542476	2023-12-11	Warnings	Exact identifier application number: M006
Vichy Laboratoires Normaderm Phytoaction Deep Cleansing	SALICYLIC ACID	COSMETIQUE ACTIVE PRODUCTION	b61a3f74-a588-47f4-b4a5-c8f97f98d9dd	2023-12-11	Warnings	Exact identifier application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Serum Acne Treatment	SALICYLIC ACID	L'Oreal USA Products Inc	c6f5e9a4-c938-4c44-ace7-a9688b227d59	2023-12-11	Warnings	Exact identifier application number: M006
Clarifying Toner	SALICYLIC ACID	Allure Labs	0c07e6e9-18c1-20da-e063-6294a90aa3c8	2023-12-08	Warnings	Exact identifier application number: M006
Acne Advanced Clarifying Hydrator	SALICYLIC ACID	Eminence Organic Skin Care Ltd.	b710cc36-f589-4116-a0a2-c6966ebebbf2	2023-12-08	Warnings	Exact identifier application number: M006
Foaming Cleanser	SALICYLIC ACID	Allure Labs	0bf4c2d8-2fbf-a1c4-e063-6294a90ac130	2023-12-07	Warnings	Exact identifier application number: M006
CLEAROGEN 3	BENZOYL PEROXIDE	Allure Labs	0bdf9f38-5763-a4d0-e063-6394a90a41dc	2023-12-06	Warnings	Exact identifier application number: M006
REPLENIX ACNE 10% WASH PARABEN FREE WITH ALOE	BENZOYL PEROXIDE	Topiderm, Inc.	ea9a32c4-3795-4718-9394-bac69091c732	2023-12-04	Warnings	Exact identifier application number: M006
Acne Advanced Treatment System	SALICYLIC ACID	Eminence Organic Skin Care Ltd.	9acf53a6-10f1-470d-b270-3a0203cf89c0	2023-12-02	Warnings	Exact identifier application number: M006
Cetaphil Gentle Clear BPO Acne Cleanser	BENZOYL PEROXIDE	Galderma Laboratories, L.P.	6397f20f-d69f-47e4-a123-4cc7e1abfcad	2023-11-29	Warnings	Exact identifier application number: M006
Acne Fighting Spot with Aloe clear	SALICYLIC ACID	Zhejiang Ayan Biotech Co.,Ltd.	db0054b1-29b9-48fa-8a02-86683bae8134	2023-11-21	Warnings	Exact identifier application number: M006
Cetaphil Gentle Clear Clarifying Acne Cleanser	SALICYLIC ACID	Galderma Laboratories, L.P.	9add83f2-7da6-4cd0-b91b-f6c937a56255	2023-11-20	Warnings	Exact identifier application number: M006
Dr. Gross AB Acne Daily Breakout	SALICYLIC ACID	Topiderm, Inc	79d7f1f6-d08f-4be0-afc1-9ab4338a954d	2023-11-20	Warnings	Exact identifier application number: M006
Dr. Dennis Gross Alpha Beta On the Spot Eliminator	SALICYLIC ACID	Topiderm, Inc	e0dccdbc-56fd-4034-b479-f2a2ebde2234	2023-11-16	Warnings	Exact identifier application number: M006
Cetaphil Gentle Clear Triple-Action Acne Serum	SALICYLIC ACID	Galderma Laboratories, L.P.	3e6eb59f-c523-460e-87ed-750b4a8cacac	2023-11-16	Warnings	Exact identifier application number: M006
Medicated Wash	SALICYLIC ACID	Vivier Pharma, Inc.	e90ab8b6-6a77-4e02-9d71-45cd7383cb0a	2023-11-14	Warnings	Exact identifier application number: M006
GOODBYE ACNE Complete treatment gel	SALICYLIC ACID	Peter Thomas Roth, LLC	09b88031-f5fe-8ae1-e063-6394a90a8a6a	2023-11-14	Warnings	Exact identifier application number: M006
L BRI Pure n Natural Deep Clean Toner	SALICYLIC ACID	L'BRI HEALTH AND BEAUTY INC	353e948e-da5d-4c15-adcb-77ef978cf05f	2023-11-11	Warnings	Exact identifier application number: M006
MD-Acne Body Acne Treatment	BENZOYL PEROXIDE	MD Algorithms Inc.	97981e9b-d56a-42f6-a75f-647b4732021e	2023-11-11	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