Isomers Clear Skin Acne Treatment Lotion

Product NDC: 64990-605
11-digit product format: 649900605
Labeler code: 64990
Product ID: 64990-605_f2a273b5-ab49-4c45-8f5b-ef9a3cecc1ed
Type: HUMAN OTC DRUG
Nonproprietary name: Salicylic Acid
Dosage form: LOTION
Route: TOPICAL
Labeler: Isomers Laboratories Inc
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2009-12-26
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 0 mL/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64990-605		I	Inactivated by FDA	2026-10-05
excluded product	product	64990-605		I	Inactivated by FDA	2026-10-05
excluded product	product	64990-605		I	Inactivated by FDA	2026-10-05
excluded package	package	64990-605	64990-605-05	I	Inactivated by FDA	2026-10-05
excluded package	package	64990-605	64990-605-07	I	Inactivated by FDA	2026-10-05
excluded package	package	64990-605	64990-605-06	I	Inactivated by FDA	2026-10-05

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 3 · 132 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
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	64990-605-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64990-605-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64990-605-05	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
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	64990-605-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64990-605-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64990-605-05	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
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	64990-605-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64990-605-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64990-605-05	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
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	64990-605-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64990-605-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64990-605-05	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
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	64990-605-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64990-605-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64990-605-05	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
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	64990-605-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64990-605-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64990-605-05	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
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	64990-605-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64990-605-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64990-605-05	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
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	64990-605-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64990-605-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64990-605-05	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
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	64990-605-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64990-605-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64990-605-05	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
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	64990-605-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64990-605-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64990-605-05	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64990-605-05	2019-10-21	C162847	48780-1	956f9ecf-ccea-621f-e053-dbdaa90a74ad	DRUG FACTS
64990-605-06	2019-10-21	C162847	48780-1	956f9ecf-cfc9-621f-e053-dbdaa90a74ad	DRUG FACTS
64990-605-07	2019-10-21	C162847	48780-1	956f9ecf-da31-621f-e053-dbdaa90a74ad	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64990-605-05	Isomers Clear Skin Acne Treatment Lotion	60 mL in 1 BOTTLE	LOTION	60	1
64990-605-06	Isomers Clear Skin Acne Treatment Lotion	120 mL in 1 BOTTLE	LOTION	120	1
64990-605-07	Isomers Clear Skin Acne Treatment Lotion	240 mL in 1 BOTTLE	LOTION	240	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
DIHEXADECYL PHOSPHATE	INACTIVE INGREDIENT	2V6E5WN99N	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
DIHEXADECYL PHOSPHATE	INACTIVE INGREDIENT	2V6E5WN99N	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
DIHEXADECYL PHOSPHATE	INACTIVE INGREDIENT	2V6E5WN99N	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
OPUNTIA FICUS-INDICA	INACTIVE INGREDIENT	23Z87HTQ6P	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
OPUNTIA FICUS-INDICA	INACTIVE INGREDIENT	23Z87HTQ6P	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
OPUNTIA FICUS-INDICA	INACTIVE INGREDIENT	23Z87HTQ6P	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64990-605	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1	Legacy NDC, 1 package rows	20100210_0320db55-4d43-439d-864b-46a18dc43f00.zip
64990-605	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1	Legacy NDC, 1 package rows	20100129_8643c2e9-225d-4f00-9155-0e209c5fec3f.zip
64990-605	ISOMERS CLEAR SKIN ACNE TREATMENT LOTION (SALICYLIC ACID) LOTION [ISOMERS LABORATORIES INC]	1	Legacy NDC, 1 package rows	20100209_83fffc5c-0e61-4083-8fac-5612f7a6911f.zip

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
103568	salicylic acid 2 % Topical Lotion	PSN	0320db55-4d43-439d-864b-46a18dc43f00	1
103568	salicylic acid 2 % Topical Lotion	PSN	83fffc5c-0e61-4083-8fac-5612f7a6911f	1
103568	salicylic acid 2 % Topical Lotion	PSN	8643c2e9-225d-4f00-9155-0e209c5fec3f	1
103568	salicylic acid 20 MG/ML Topical Lotion	SCD	0320db55-4d43-439d-864b-46a18dc43f00	1
103568	salicylic acid 20 MG/ML Topical Lotion	SCD	83fffc5c-0e61-4083-8fac-5612f7a6911f	1
103568	salicylic acid 20 MG/ML Topical Lotion	SCD	8643c2e9-225d-4f00-9155-0e209c5fec3f	1
103568	salicylic acid 2 % Topical Lotion	SY	0320db55-4d43-439d-864b-46a18dc43f00	1
103568	salicylic acid 2 % Topical Lotion	SY	83fffc5c-0e61-4083-8fac-5612f7a6911f	1
103568	salicylic acid 2 % Topical Lotion	SY	8643c2e9-225d-4f00-9155-0e209c5fec3f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
64990-605-05	64990060505	60 mL in 1 BOTTLE	60 ml	Historical
64990-605-06	64990060506	120 mL in 1 BOTTLE	120 ml	Historical
64990-605-07	64990060507	240 mL in 1 BOTTLE	240 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Isomers Laboratories Inc	2010-02-10	HUMAN OTC DRUG LABEL	1
DRUG FACTS	Isomers Laboratories Inc	2010-02-09	HUMAN OTC DRUG LABEL	1
DRUG FACTS	Isomers Laboratories Inc	2010-01-25	HUMAN OTC DRUG LABEL	1